December 2006
Posted on December 29, 2006 @ 08:38 am
MedImmune, Inc. has signed a license agreement with Japan Tobacco, Inc. (JT) with the intent to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases. MedImmune will initially focus on developing the current lead antibody to inhibit a receptor believed to play a key role in controlling adaptive immune responses, called inducible-costimulator (ICOS), and thereby regulate T-cell dependent activation of B cells. Inappropriate activation of T cells resulting in B-cell activation is related to a variety of autoimmune disorders.
"The addition of this novel target to MedImmune's inflammatory disease pipeline underscores our commitment to developing innovative therapies for the treatment of unmet medical needs, such as systemic lupus erythematosus (SLE or lupus), Sjogrens syndrome and rheumatoid arthritis," said Anthony J. Coyle, Ph.D., MedImmune senior director, research, and head, inflammation biology. "As we work to develop the anti-ICOS MAb as a potential treatment for such immune system disorders, we also hope to continue to collect scientific knowledge related to the role of signaling pathways in regulating immune response outcomes."
Under the terms of the agreement, JT will receive an undisclosed upfront payment, milestone payments and royalties on any future marketed products. JT has exclusive development and marketing rights for the current lead antibody in Japan. MedImmune has exclusive development and marketing rights to this antibody for the rest of world and certain rights worldwide for other antibodies developed as a result of the agreement.
Posted on December 29, 2006 @ 08:33 am
AstraZeneca (AZ) plans to continue development of AZD3480 (TC-1734) in Alzheimer's disease (AD) and cognitive deficits in schizophrenia, triggering a $20 million milestone payment to
Targacept, Inc. This decision follows the completion of previously disclosed studies of AZD3480 (TC-1734) by AZ.
"AZ is committed to developing innovative therapies in the areas of unmet need of AD, schizophrenia and other cognitive disorders. Our decision to continue clinical development of AZD3480 demonstrates our belief in the cognitive-enhancing potential of NNR-targeted therapeutics," said Bob Holland, vice president and head of the neuroscience therapy area, AZ. "We are very pleased with our research collaboration with Targacept. We entered into the collaboration excited about the prospects of combining Targacept's longstanding leadership position in NNR research with our existing strengths, and the progress made in a relatively short time has been impressive."
"We are delighted with AZ's plans to move forward with development of AZD3480 in these two areas where a significant medical need is clear. We believe that the effects on cognition that we observed in our previous nine clinical trials of this product candidate in approximately 400 subjects show its potential as a treatment for cognitive disorders," said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept.
Posted on December 29, 2006 @ 08:27 am
Crucell has signed a cross-licensing agreement with
Merck allowing Merck to use its technology on an exclusive basis in undisclosed vaccine fields. In turn, Crucell will receive access to Merck's large scale manufacturing technology for its AdVac-based vaccines.
"This agreement will make it possible to speed up the delivery of our malaria and TB vaccines to the people in need, and makes it realistic to do so on the mass scale required," said Jaap Goudsmit, chief scientific officer at Crucell. "It also opens the way for Crucell to speed up the Ebola program with the VRC, which has recently entered a Phase I trial. But most importantly, it brings the reality of vaccines such as these significantly closer."
Posted on December 27, 2006 @ 08:58 am
GlaxoSmithKline and
Praecis Pharmaceuticals, Inc. entered into a definitive agreement whereby GSK will acquire all outstanding shares of Praecis for a total of approximately $54.8 million.
Praecis, a biopharmaceutical company, has a novel MetAP-2 inhibitor, PPI-2458, in clinical development for cancer indications, including non-Hodgkin's lymphoma and solid tumors, a drug discovery technology, DirectSelect, which enables the generation of large libraries for the discovery of orally active compounds for drug development, and a R&D program aimed at identifying one or more selective S1P-1 agonist compounds to advance into clinical testing.
"Praecis has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities," said Allen Oliff, senior vice president, molecular discovery research, GSK.
Kevin F. McLaughlin, Praecis' president and chief executive officer, stated, "We are pleased to announce this transaction which culminates a process initiated and directed by our Board to enhance and realize value for our stockholders."
The acquisition, subject to certain conditions, has been approved by the boards of directors of both companies and is expected to close in the first quarter of 2007.
Posted on December 27, 2006 @ 08:55 am
Albany Molecular Research, Inc. (AMRI) has entered into a two-year natural products-based drug discovery collaboration with
Bristol-Myers Squibb. Under the terms of the agreement, AMRI will test samples from its natural product hit seeking collections against multiple drug targets in a range of therapeutic areas. AMRI may provide follow-up medicinal chemistry hit-to-lead optimization, biocatalysis or chemical synthesis support on compounds of interest to BMS.
The collaboration includes an upfront payment, research funding and opportunities for AMRI to receive milestone payments based on the achievement of specific development and commercialization goals. AMRI would also receive royalty payments on sales of products that result from the collaboration.
"We are pleased to announce this natural products relationship with BMS," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "This collaboration draws on AMRI's breadth of drug discovery technologies, from our diverse collection of natural products and high throughput screening, to world class hit-to-lead optimization."
Posted on December 27, 2006 @ 08:49 am
Valeant Pharmaceuticals has sold certain discovery and preclinical assets to Ardea Biosciences, Inc. (formerly IntraBiotics Pharmaceuticals). The sale includes the rights to Valeant's HIV and cancer development programs.
Under the terms of the agreement, Ardea will make payments to Valeant upon the achievement of clinical milestones for both HIV and cancer programs. Valeant will retain an option to reacquire rights to commercialize its HIV program outside of the U.S. and Canada upon Ardea's completion of Phase III trials. Ardea will pay Valeant development milestones and royalties upon its commercialization of the HIV and cancer programs. Ardea may receive milestone and royalty payments related to the clinical advancement and commercialization of the HIV program should Valeant exercise its option to this program.
Timothy C. Tyson, Valeant's president and chief executive officer, said, "The sale to Ardea is another significant step forward in the execution of our restructuring initiative. The agreement will further the development of important programs for HIV and other therapies while allowing us to retain an interest in the commercial rights to our HIV compounds."
Posted on December 27, 2006 @ 08:44 am
Merck and
Vertex Pharmaceuticals, Inc. began an international Phase II trial of MK-0457 (also known as VX-680), a small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study will be conducted in patients with treatment-resistant chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) containing the T315I BCR-ABL mutation. With the start of dosing, Vertex earned a $25 million milestone payment from Merck.
"This pivotal trial based on a population prospectively defined by a genetic marker will hopefully represent a new paradigm for development of drugs targeting specific cancer patient populations," said Stephen H. Friend, M.D., Ph.D., executive vice president and franchise head, oncology and neuroscience, Merck Research Labs. "MK-0457 is the first compound to show clinical activity in patients with certain treatment-resistant forms of blood cancers. Based on encouraging Phase I results reported recently at the American Society of Hematology meeting, we are moving forward with this international Phase II trial in these patients."
Merck will conduct the trial of MK-0457, which is expected to enroll approximately 270 adult patients with advanced CML and ALL leukemias harboring the T315I BCR-ABL mutation. MK-0457 will be given as a five-day intravenous infusion every two-to- three weeks to evaluate safety and efficacy. Merck may seek marketing approval for MK-0457 based on the data generated in this trial. The study has been designed to support registration of MK-0457 in one or more cancer indications for which there is currently little or no effective treatment.
Posted on December 20, 2006 @ 09:36 am
Kosan Biosciences, Inc. has established a worldwide license agreement with
Pfizer for its motilin agonist program. The agreement includes Kosan's clinical candidate, KOS-2187 and related compounds. KOS-2187 has demonstrated improved gastric emptying in preclinical studies and may have therapeutic benefit in gastrointestinal diseases such as gastro- esophageal reflux disease (GERD), or diabetic gastroparesis (delayed gastric emptying).
Under the terms of the license agreement, the two companies will file regulatory documents and initiate a Phase I trial of KOS-2187. Pfizer will be responsible for all development, regulatory and commercial activities related to the motilin agonist program. Kosan will receive an upfront payment of $12.5 million and will be eligible to receive as much as $250 million for the successful development and commercialization of KOS-2187 for one indication, as well as royalties on worldwide sales.
"We have achieved a major corporate goal by partnering our gastrointestinal-focused motilin agonist program with Pfizer," said Robert G. Johnson, Jr., M.D., Ph.D., president and chief executive officer of Kosan. "Kosan is focused on advancing novel cancer therapeutics, as evidenced by our advancing Hsp90 inhibitor and epothilone oncology programs which are progressing into later-stage clinical development. Our motilin agonist program is the most promising polyketide-based, non-oncology asset to emerge from our proprietary discovery platform. This agreement with Pfizer further underscores Kosan's ability to convert technology into valuable product opportunities."
"Pfizer believes that the mechanism of action of KOS-2187 and its demonstrated activity as a prokinetic agent are significant indications of its potential as a new approach for the treatment of gastrointestinal diseases," said James Bristol, senior vice president, Pfizer World Wide Discovery Research. "We believe that KOS-2187 is a valuable addition to Pfizer's GI portfolio."
Posted on December 20, 2006 @ 09:22 am
Altus Pharmaceuticals, Inc. has entered into an agreement with
Genentech to develop, manufacture and commercialize ALTU-238, Altus' subcutaneous formulation of human growth hormone (HGH), which employs Altus' protein crystallization and formulation technology, for patients with growth hormone deficiencies.
The alliance and license agreement is exclusive to North America with an option for a global agreement. Genentech will make a $15 million upfront payment to Altus with the potential for Altus to receive additional payments of approximately $140 million based on development and commercialization milestones. Genentech will also invest $15 million in Altus through the purchase of shares. Genentech has a global commercialization option for ALTU-238 whereby Altus could receive additional payments of more than $110 million.
Under the terms of the agreement, Genentech will be responsible for ALTU-238 development and commercialization costs in North America and the two companies will co-promote and market ALTU-238. The agreement may be subject to Hart-Scott-Rodino approval under U.S. antitrust laws and customary closing conditions.
"The Altus and Genentech alliance is an important strategic move that we believe further validates ALTU-238 as a long-acting product candidate for growth hormone deficient patients as well as the value of our protein crystallization platform," stated Sheldon Berkle, president and chief executive officer of Altus Pharmaceuticals. "Through this agreement, we are now collaborating with a premier biopharmaceutical company that is a leader in the U.S. growth hormone market. We believe that Genentech's development experience as well as their knowledge of the regulatory and commercial environments for growth hormone products should contribute to even greater potential for ALTU-238."
Posted on December 20, 2006 @ 09:17 am
Curis, Inc. has made key promotions within its management team infrastructure. The changes are part of the company's strategy to better align the management structure for its plan to move away from early stage discovery research to develop later stage preclinical and, ultimately, clinical assets. The first later stage program includes cancer targets that are currently in preclinical testing. Curis expects to select the first lead candidate in early 2007 and file an IND during the second half of 2007.
Michael P. Gray, senior vice president of finance and chief financial officer, will assume the additional role of chief operating officer. Mr. Gray will continue to be responsible for a majority of Curis' administrative functions and will now have a greater role in aligning Curis' drug development programs with the company's overall objectives and operating budget.
"Mike Gray has been an important part of the Curis team and has consistently demonstrated strong management and leadership skills during his tenure," said Dan Passeri, president and chief executive officer of Curis. "I will be looking to Mike to lead the coordination of the company's drug development and administrative efforts as we seek to move our drug programs into later stages of development in a highly effective and cost-efficient manner."
Also,
Dr. Changgeng Qian has been promoted to the position of vice president, discovery and preclinical development. Dr. Qian joined the company in 2001, with more than 25 years of academic and industrial experience in drug discovery, including pharmacokinetics, drug metabolism, efficacy evaluation, experimental disease model development and drug safety assessment. He has played key roles in the discovery and development of several drug candidates, including cancer and central nervous system indications at CytoMed, Inc., LeukoSite, Inc., and Millennium Pharmaceuticals, Inc.
"Dr. Qian brings tremendous experience and scientific leadership to his new role. He has been an invaluable asset to Curis, both in his guidance surrounding Curis' programs under collaboration, and in his leadership in directing Curis' proprietary multi-targeted inhibitor (MTI) programs. We are extremely pleased to have someone of Dr. Qian's caliber leading these scientific efforts." Mr. Passeri said.
Posted on December 20, 2006 @ 09:13 am
MorphoSys has expanded its therapeutic antibody collaboration with
Pfizer through 2011, triggering a payment from Pfizer. Under the extended agreement, Pfizer has the option to begin new therapeutic antibody projects with MorphoSys, resulting in the potential for MorphoSys to receive development milestone payments exceeding $100 million. Further financial details were not disclosed.
The agreement, originally signed in December 2003, was scheduled to end in December 2008. Under the extended agreement, MorphoSys will continue to use its HuCAL GOLD library to generate therapeutic antibodies against multiple new targets from Pfizer. Pfizer will conduct preclinical and clinical development and the subsequent marketing of resulting products. MorphoSys may receive increased research funding as well as milestone and royalty payments on any antibody products derived from the collaboration. The collaboration currently has five active therapeutic antibody programs.
"We are very pleased by the successful progress in our collaboration with Pfizer and their decision to intensify this alliance, which will now run until 2011," said Dr. Simon Moroney, chief executive officer of MorphoSys. "The year 2006 in review has been very successful for MorphoSys. This news represents the fourth substantial expansion of an existing deal for MorphoSys in 2006. In combination with three new commercial partnerships signed during the year, this development demonstrates the strong performance of our partnered therapeutic business."
Posted on December 19, 2006 @ 08:55 am
Bridge Pharmaceuticals, Inc. has acquired
Gene Logic Labs (GLL), based in Gaithersburg, MD. Bridge will retain the services of all GLL employees, and the acquired unit’s name will become Bridge Global Development Services, Inc. (a subsidiary of Bridge Pharmaceuticals, Inc). Also, the two companies have entered into a preferred services agreement for preclinical drug development.
The acquisition of the Gene Logic Labs Gaithersburg facility enables Bridge to offer a complete IND suite of toxicology and pharmacology services on a global scale, according to the company. Combining the experience, technical staff and resources of U.S. operations with existing scientific staff in its new, purpose-built facility in Beijing, China, Bridge will provide the pharma industry with the high quality data required for worldwide regulatory submissions with "very significant cost savings."
“Many clients see the economies associated with performing preclinical work in Asia and want the assurances that work done there would be performed under the strict guidelines of U.S. level GLP regulatory requirements,” said Glenn Rice, Ph.D., chief executive officer and president of Bridge. “The GLL acquisition allows us to offer the unique benefits of our China facilities with the assurance of the regulatory compliance that clients require.”
Posted on December 19, 2006 @ 08:53 am
Avid Bioservices, Inc., a subsidiary of Peregrine Pharmaceuticals, Inc., has extended its commercial manufacturing supply agreement with
Halozyme Therapeutics, Inc. Under the terms of the contract amendment, Avid could manufacture as many as 20 runs per year during the next five years of a recombinant human enzyme that is the active ingredient in Halozyme's marketed products, Hylenex and Cumulase. Avid began manufacturing commercial product for Halozyme under cGMP in 2004.
"We are pleased to extend our contract with Avid to manufacture our recombinant human enzyme that is a key ingredient in Hylenex and Cumulase," said William Fallon, vice president of manufacturing and operations at Halozyme. "Avid's proven capabilities in cGMP manufacturing support our ability to increase sales of both marketed products."
"We are delighted that Halozyme has re-confirmed their confidence in Avid's capabilities by extending the term of the agreement for five additional years, while also significantly expanding its potential scope," said Richard Richieri, senior vice president of bioprocess development and manufacturing at Avid. "We have had a very productive relationship with Halozyme over the past few years and are pleased to be the primary manufacturer for this important commercial product and technology."
Posted on December 19, 2006 @ 08:51 am
GlaxoSmithKline and
Genmab have entered a worldwide agreement to co-develop and commercialize HuMax-CD20, a human monoclonal antibody in late stage development for CD20 positive B-cell chronic lymphocytic leukemia (B-CLL) and follicular non-Hodgkin's lymphoma (NHL) and in Phase II for rheumatoid arthritis (RA). The agreement is subject to review under the Hart-Scott-Rodino Act.
Under the terms of the agreement, Genmab will receive a license fee of approximately $102 million, and GSK will invest approximately $357 million in Genmab. The potential value of this agreement, in the event of commercial success in cancer and various autoimmune and inflammatory diseases, could exceed $2.1 billion. Genmab will also be entitled to receive tiered royalties on global sales of HuMax-CD20.
GSK will receive an exclusive worldwide license to HuMax-CD20 as well as other antibodies with affinity for the CD20 antigen, which Genmab may develop. GSK will also have an exclusive option to a CD20 UniBody to be developed in collaboration with Genmab. The two companies will co-develop HuMax-CD20. Genmab will be responsible for development costs until 2008, including two ongoing late-stage oncology studies after which development costs will be shared. GSK will be solely responsible for the manufacturing and commercialization of HuMax-CD20.
Genmab will have an option to co-promote HuMax-CD20 in a targeted oncology setting in the U.S. and in the Nordic region. Should this be undertaken, Genmab will have the option co-promote Bexxar and Arranon in the U.S. and Atriance in the Nordic region.
Dr. Moncef Slaoui, chairman of R&D, GSK, commented, "We believe that this alliance is a significant step for GSK and Genmab. By combining the skills and knowledge of Genmab in developing fully human antibodies, such as HuMax-CD20, and the substantial experience of GSK in clinical and commercial development, we hope to be able to bring this innovative and potentially valuable medicine to patients as soon as possible."
Posted on December 18, 2006 @ 09:07 am
Exelixis, Inc. and
Bristol-Myers Squibb have entered into a worldwide collaboration to discover, develop and commercialize novel targeted therapies for the treatment of cancer.
Under the collaboration, Exelixis will use its drug discovery platform for the identification and preclinical development of small molecule drug candidates directed against mutually selected targets. BMS will have the right to select as many as three IND candidates against three different targets. BMS will then lead all global activities and the two companies will co-develop and co-commercialize the programs in the U.S.
Under the terms of the agreement, BMS will make an upfront payment of $60 million in cash and Exelixis will also receive $20 million for each of the drug candidates selected by BMS as INDs. Exelixis will also receive royalties on product sales outside of the U.S. For each program selected by BMS, Exelixis may opt out of the co-development or co-promotion in the U.S., in which case Exelixis would receive milestones and royalties in lieu of a U.S. profit share.
"We are very pleased to collaborate with BMS on the discovery and development of novel treatments for cancer," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "This collaboration will capitalize on the power of Exelixis' drug discovery engine and on the breadth and depth of BMS' expertise in oncology. We have had excellent, productive collaborations with BMS in oncology since 2000, and I am confident that this new collaboration will build on this excellent relationship and on the knowledge that we have generated during those years."
Posted on December 18, 2006 @ 09:05 am
Amgen broke ground for the expansion of its Louisville, KY Distribution Center. The $38 million expansion and improvement project will add 27,000 sq. ft. to the existing building infrastructure and is scheduled for completion in 2007.
"The expansion of our Louisville Distribution Center will help enable Amgen to meet growing demand for our current marketed products and prepare for new medicines from our pipeline in the years ahead," said Dennis Fenton, Amgen executive vice president, operations. "We are proud of our Kentucky site and grateful to the area's elected federal, state and local officials and business community for supporting our operations."
Posted on December 18, 2006 @ 09:02 am
Pablo J. Cagnoni, M.D. has been promoted to vice president and chief medical officer,
OSI Pharmaceuticals, Inc. In this position, Dr. Cagnoni will oversee all of the clinical development and medical affairs activities of the company's oncology portfolio, which includes further development of Tarceva. Dr. Cagnoni has also been appointed as an officer of the corporation and will serve as a member of the company's executive management committee.
"Pablo has shown excellent leadership in managing Tarceva's development program as well as the company's oncology clinical operations during his tenure," stated Colin Goddard, chief executive officer of OSI Pharmaceuticals. "As the company continues to build a top-tier oncology franchise upon the success of Tarceva, Pablo's expertise in oncology will play an integral role in advancing innovative molecular targeted therapies within our pipeline."
Dr. Cagnoni has 20 years of clinical development experience in oncology in both biotechnology and academic settings. He previously served as vice president, clinical development and medical affairs at OSI. Before joining the company in 2004, Dr. Cagnoni was vice president of clinical development at Allos Therapeutics, where he headed the development organization and led the development of Efaproxyn and pralatrexate. Prior to that, Dr. Cagnoni was assistant professor of medicine in the Division of Oncology at the University of Colorado. Dr. Cagnoni has authored more than 50 publications, numerous book chapters and has lectured extensively in several areas related to clinical oncology and drug development.
Posted on December 15, 2006 @ 08:57 am
Thermo Fisher Scientific, Inc. has acquired
Cohesive Technologies, Inc., adding in-line sample preparation capabilities that couple with mass spectrometry technology to create end-to-end workflow solutions for drug and other organic molecule analyses. These new capabilities improve sample throughput and increase detection limits during LC/MS/MS analysis for customers in the pharmaceutical, clinical, environmental and food science industries. Based in MA, Cohesive Technologies manufactures advanced sample extraction and liquid chromatography products.
"Cohesive's sample preparation technologies will strengthen our ability to offer customers the advanced tools they need to accelerate research and discovery and to provide them with higher-quality analytical information," said Marijn E. Dekkers, president and chief executive officer of Thermo Fisher Scientific. "We look forward to integrating Cohesive into Thermo Fisher Scientific, and to making their sample preparation capabilities available to customers worldwide through our global sales channels."
Posted on December 15, 2006 @ 08:55 am
Crucell has received its first orders for the CMO agreement with NJ-based
Wyeth Biotech. The agreement for formulation and filing of a vaccine was finalized at the end of 2005 and will have the first business impact for Crucell in 2007. The vaccine will be supplied from Crucell's Swiss subsidiary.
Posted on December 15, 2006 @ 08:53 am
Bob Tepper, M.D., R&D president, is leaving
Millennium in the first quarter of 2007. Dr. Tepper was one of the founding executives in 1994 and was an integral part of its expansion from a drug discovery company to a fully-integrated biopharmaceutical company with nine novel molecules in development and market-leading product, Velcade for Injection for relapsed multiple myeloma and mantle cell lymphoma.
"Bob was one of a small group of people who had a vision for forming a new company that could make a difference in the way medicine is discovered to change the lives of patients," said Millennium president and chief executive officer Deborah Dunsire, M.D. "Today that vision is a reality and Millennium is indeed improving the lives of patients with multiple myeloma and mantle cell lymphoma, with a strong and diverse pipeline behind Velcade. I would like to thank Bob for his vision and relentless commitment to scientific excellence."
Posted on December 14, 2006 @ 09:20 am
Forest Laboratories, Inc. has signed a definitive merger agreement to acquire
Cerexa, Inc. for $480 million cash. As part of the acquisition, Forest will obtain worldwide development and marketing rights (excluding Japan) to two injectable antibiotics and an option to a third, early stage injectable antibiotic. The lead compound, ceftaroline acetate, which is entering Phase III studies, is a next generation, broad-spectrum, hospital-based cephalosporin antibiotic that is being developed for initial indications of complicated skin and skin structure infections (cSSSI) and community acquired pneumonia (CAP).
The second product, ME1036, a broad-spectrum parenteral carbapenem, is currently in preclinical development and has demonstrated activity against both aerobic and anaerobic Gram-positive and Gram-negative bacteria, including common drug-resistant pathogens.
"Ceftaroline is an important late-stage development product that can address serious and life-threatening infections in the hospital setting including MRSA. We have a high degree of confidence in the successful commercialization and financial prospects for ceftaroline given the strength of the existing clinical data and the need for a next generation hospital based antibiotic," commented Howard Solomon, chairman and chief executive officer of Forest.
Dennis Podleask, Cerexa's chief executive officer, added, "We received significant interest in Cerexa from multiple parties and are delighted to be entering into this transaction with Forest, who will be assuming responsibility for the development and future commercialization of ceftaroline. Forest has a proven track record of success in developing and commercializing products and we have great confidence in their ability to optimize the therapeutic and commercial potential of the Cerexa portfolio."
The transaction is expected to close in Forest's fourth quarter following the expiration of the Hart-Scott-Rodino antitrust waiting period.
Posted on December 14, 2006 @ 09:18 am
HollisterStier Contract Manufacturing has signed a manufacturing contract with
GeneraMedix, Inc. to develop a process for compounding and lyophilizing multiple generic drug products. GeneraMedix plans to use HollisterStier's project management system to meet timelines and project specifications. Further details of the agreement were not disclosed.
Anthony Bonanzino Ph.D., president and chief executive officer of HollisterStier said, "Establishing this new arrangement with GeneraMedix is further evidence of HollisterStier's substantial technical competency. Merging the core competencies of each organization assures a rapid market introduction to meet this important patient need."
Ronald F. Quadrel, president and chief executive officer of GeneraMedix said, "This new agreement with HollisterStier Contract Manufacturing is another step in the development and buildup of our generic injectable product portfolio. We are very pleased to be working together with HollisterStier on these new products. We believe that HollisterStier has the team, the experience and the infrastructure to ensure the successful development and commercial supply of these products."
Posted on December 14, 2006 @ 09:16 am
Abbott has acquired a majority of the shares of
Kos Pharmaceuticals, Inc. for $3.7 billion. The acquisition follows a scheduled expiration on December 12th for the purchase of all outstanding common stock of Kos. Abbott's shares now represent approximately 91.4% of Kos' outstanding shares.
The merger is expected to occur within the next few days.
Posted on December 13, 2006 @ 09:37 am
Holmes Biopharma, Inc. has signed a letter of intent to purchase an existing pharmaceutical development, clinical manufacture, biotechnology, and analytical laboratory business located in the eastern U.S. The name and terms of the acquisition will be disclosed in the coming weeks.
"This strategic acquisition provides Holmes Biopharma with a profitable subsidiary, secure supply of drug samples for the contract research business, and entry into the drug development business," stated John F. Metcalfe, president of Holmes.
Posted on December 13, 2006 @ 09:28 am
Boehringer Ingelheim Pharmaceuticals, Inc. has chosen to exercise options in its original agreement with
Graffinity Pharmaceuticals that will increase the number of targets screened by Graffinity as part of this global alliance. Under the terms of the agreement, Graffinity will receive additional technology access fees for the generation of multiple small molecule hit series against a variety of drug targets from different therapeutic areas.
Graffinity will apply its fragment based drug discovery technology and drug fragment chemical microarrays to identify small molecule hit structures focusing on compounds with novel modes of action. Financial details were not disclosed.
Kristina Schmidt, chief executive officer of Graffinity, remarked, "Boehringer Ingelheim is taking full advantage of our proprietary process for rapidly identifying quality fragment hits. We believe that this collaboration is a validation of Graffinity's approach of accelerating drug discovery through innovations in fragment based drug discovery."
Posted on December 13, 2006 @ 09:23 am
BASF Corp. has selected
Mutchler, Inc. to serve as an authorized distributor of pharmaceutical excipients in the U.S.
“We have selected Mutchler based on its ability to meet and exceed the expected service levels required of a company representing our product portfolio,” said Kelley DaVanon, pharma solutions distribution manager for BASF in North America. “We believe that our partnership with Mutchler will help us to better serve the market and help us expand our customer base.”
Mutchler, located in Harrington Park, NJ, has served as the company's distributor for pharmaceutical excipients in PR for the past five years.
“Mutchler is a leader in providing quality products at competitive prices, on-time deliveries and courteous service to the pharmaceutical industry,” said Glenn Mutchler, president of Mutchler.
Posted on December 12, 2006 @ 09:40 am
GlaxoSmithKline and
EPIX Pharmaceuticals have entered a worldwide multi-target strategic collaboration to discover, develop and market medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases, including EPIX's novel 5-HT4 partial agonist program, PRX-03140, in early-stage clinical development for the treatment of Alzheimer's disease. The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery (CEEDD).
EPIX will receive initial payments of $35 million and will be eligible to earn potential milestones of as much as $1.2 billion based on the achievement of certain discovery, development, regulatory and commercial milestones across the four GPCR programs. EPIX will also receive royalties on sales by GSK of all collaboration-developed product sales.
EPIX will be responsible for the discovery and development of small molecule drug candidates, including PRX-03140 for the treatment of Alzheimer's disease, through to clinical proof of concept, at which point GSK will have an exclusive option to license each product for further development and commercialization on a worldwide basis. If GSK exercises the option to license EPIX's 5-HT4 partial agonist program, EPIX will retain the right to co-promote any products from that program in the U.S.
"We are very pleased to enter into this collaboration with GSK, a world-class pharmaceutical company," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "This alliance will provide us with access to significant capital in the near and long term to support the ongoing development of PRX-03140 and three additional programs, as well as the ability to continue to move forward our existing programs. Furthermore, the co-promotion option in this collaboration provides further opportunity for EPIX to build a sales force in the future."
Posted on December 12, 2006 @ 09:39 am
Indevus Pharmaceuticals and
Valera Pharmaceuticals have entered into a definitive agreement under which Indevus will acquire Valera in a transaction valued at $120 million plus contingent payments based on future product milestones.
Valera focuses on the development and commercialization of urology and endocrinology products. The company markets Vantas for advanced prostate cancer and has multiple products in clinical development including Supprelin-LA for central precocious puberty for which the company has filed an NDA. The company also expects to submit an sNDA in the first half of 2007 for Valstar for the treatment of BCG-refractory bladder cancer. Other products in development include a biodegradable ureteral stent for post-kidney stone lithotripsy and an octreotide implant for the treatment of acromegaly.
"The acquisition of Valera firmly establishes Indevus as an emerging leader in the specialty areas of urology and men's health and fully leverages our national sales force," said Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Upon closing, Indevus' robust product portfolio will include three marketed products and the combined company anticipates five new product launches within two years, including three products from Valera."
"We have greatly admired Indevus as a company and we believe this partnership is a smart fit for Valera. As we entered into discussion for a co-promotional arrangement with Indevus, it became apparent that our product offerings, the patient and physician benefits, and the potential for shareholder returns would be enhanced by leveraging the strengths of the combined companies," stated David S. Tierney, M.D., president and chief executive officer of Valera.
Dr. Tierney will provide consulting services during a transition period after the completion of the transaction. Valera's facility in Cranbury, NJ, which contains manufacturing operations and R&D capabilities, will be maintained and become an integral part of Indevus' operations.
Posted on December 12, 2006 @ 09:36 am
Millennium Pharmaceuticals reported overall response rates (ORR) as high as 75% from Phase II trials of Velcade for Injection combination therapy across four subtypes of non-Hodgkin's lymphoma (NHL): follicular, marginal zone, mantle cell lymphoma (MCL) and T-cell lymphoma. These data include positive results from the Phase II study of Velcade in combination with rituximab in follicular lymphoma, which served as the basis for an ongoing Phase III registration-enabling trial initiated earlier this year.
The multicenter Phase II study evaluated the safety and efficacy of Velcade in combination with rituximab in 81 patients with follicular or marginal zone lymphoma. ORR was 53% among patients treated with once-weekly Velcade and 57% among patients treated in the twice-weekly arm. Median time to progression (TTP) was nine months among patients treated with once- weekly and 9.9 months among patients treated with twice-weekly Velcade. Therapy was well tolerated.
Based on these results, a randomized Phase III trial of Velcade in combination with rituximab compared to rituximab alone was initiated earlier this year under a Special Protocol Assessment (SPA) with the FDA. Velcade received approval from the FDA on December 8, 2006 for treatment of patients with MCL who have received at least one prior therapy, marking the first indication for Velcade in lymphoma and the first therapy to receive FDA approval in this treatment setting.
The company also reported results from several clinical trials of Velcade for Injection combination therapies for treatment of relapsed multiple myeloma (MM). The results of these trials showed overall response rates (ORR) as high as 93% and complete and near complete response (CR/nCR) rates as high as 43%. Based on an interim analysis of a randomized Phase III trial announced by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), Velcade in combination with Doxil achieved a statistically significant improvement in time to disease progression (TTP), the primary endpoint of the study, compared to Velcade alone.
Posted on December 11, 2006 @ 11:10 am
Microtest has enhanced its analytical lab services with the installation of a new, advanced technology, MicroSeq Microbial Identification System from Applera Corp. The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.
Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period, according to a company statement. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.
"In the highly competitive biotechnology industry, accuracy and speed cannot be compromised," stated Dr. Steven Richter, Microtest's president. "Our new MicroSeq system enables our specialists to provide customers with consistent and rapid results that, unlike previous equipment, ensures that the issues and concerns that prompted our clients to undertake their testing are properly analyzed and resolved, thus putting their production back on track."
The new system is integrated for use across the spectrum of services that Microtest provides, including contract manufacturing, pharmaceutical testing & validation, medical device testing & validation, environmental control and testing, water validation, mold identification, and biologics/virology, according to the company.
Posted on December 11, 2006 @ 10:02 am
Merck has formed a broad collaboration with
Idera Pharmaceuticals to research, develop and commercialize Idera's Toll-like Receptor (TLR) agonists by incorporating them in therapeutic and prophylactic vaccines being developed by Merck for oncology, infectious diseases and Alzheimer's disease.
"Our collaboration with Idera is part of Merck's long-standing commitment to research and develop novel vaccines and medicines that can improve human health," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We believe that vaccines combined with TLR-targeted compounds offer great promise in treating and preventing serious diseases, and look forward to integrating Idera's TLR agonists into our vaccine development programs."
Under the terms of the agreement, Merck will receive worldwide exclusive rights to a number of Idera's agonist compounds targeting TLR 7, 8 and 9 for use in combination with Merck's therapeutic and prophylactic vaccines under development for oncology, infectious diseases and Alzheimer's disease. Merck and Idera will engage in a two-year R&D collaboration to generate novel agonists targeting TLR 7 and TLR 8 and incorporating both Merck and Idera chemistry for use in the licensed fields.
Merck has agreed to pay an upfront license fee of $20 million to Idera and to purchase $10 million of its common stock at $5.50 per share. In addition, Merck will fund the R&D collaboration. Idera is eligible to receive milestone payments of as much as $165 million if vaccines are successfully developed in each of the three fields. Additional milestones of as much as $260 million would be payable for follow-on indications in the oncology field and the successful development of additional vaccines containing Idera's TLR agonists. There is no limit to the number of vaccines to which Merck can apply Idera's agonists within the licensed fields. In addition, Idera will receive royalties on products commercialized under the collaboration.
Posted on December 11, 2006 @ 10:00 am
Parexel International Corp. has created a new, strategic leadership position of chief information officer and has appointed
Christopher Rieder to the role. Managing the company's global information technology initiatives and worldwide IT leadership and staff, Mr. Rieder is responsible for accelerating the integration of technology solutions, information management and business processes to benefit Parexel's clients and worldwide employees.
Mr. Rieder has more than 20 years of IT experience in translating business objectives into technological requirements and managing global IT organizations in application development and implementation as well as system integration. Prior to joining Parexel, he was vice president of IT at Kos Pharmaceuticals, where he built a customer-centric IT division, determined IT strategy, and directed all corporate-wide IT initiatives. Previously, he held senior IT management positions at BRI International, a contract research organization, and at North American Vaccine, a provider of pediatric-based vaccines.
Posted on December 8, 2006 @ 09:24 am
GlaxoSmithKline (GSK) has entered an agreement to acquire
Domantis Ltd., an antibody therapy developer, for $451 million in cash. The acquisition expands GSK's biopharmaceuticals portfolio of antibody technology.
Domantis, a privately-held British company, will become part of GSK's Biopharmaceuticals Centre of Excellence for Drug Discovery (CEDD) but will continue to operate from its labs in Cambridge. Domantis' current research programs include antibody therapies for rheumatoid arthritis and asthma. The acquisition is expected to complete in January.
"Domantis has pioneered the extension of antibody therapies to potentially far wider applications than has been possible with conventional monoclonal antibodies," said Mike Owen, senior vice president, Biopharmaceuticals CEDD, GSK. "Its talent and world-leading technology will complement the work we are already taking forward in the CEDD to put GSK at the forefront of biotechnology."
Robert Connelly, Domantis founding chief executive officer, said, "The agreement with GSK allows us to embed our R&D organization intact within a company committed to fully exploiting the potential therapeutic applications of our technology. I am delighted that GSK has made this major investment in our technology, our people, and our product pipeline."
Posted on December 8, 2006 @ 09:22 am
The Synthetic Organic Chemical Manufacturing Association (SOCMA) named the winners of its 2006 Performance Improvement Awards, recognizing manufacturing facilities that demonstrate outstanding commitment to continuous improvement in environmental, health, safety and security (EHS&S). The awards will be given out at SOCMA's Annual Dinner on December 11, 2006.
SOCMA will honor the following three facilities with the Excellence Award: ISOCHEM, Inc., Lockport, NY, SACHEM, Inc., Cleburne, TX, and BASF Corp., Spartanburg, DC.
"On behalf of all SOCMA members, I thank these companies for their commitment to improved EHS&S performance and active engagement with their communities," said SOCMA president and chief executive officer, Joe Acker. "These companies set a high example for the industry and deserve to be commended."
A total of 42 SOCMA member facilities will be given the Achievement Award, which goes to facilities maintaining strong EHS&S programs. The names of these facilities can be found on SOCMA’s website at www.socma.org. Both awards promote continuous improvement in the areas of pollution prevention, process safety, employee health product stewardship, community awareness, and emergency response. The awards are sponsored by SOCMA’s ChemStewards program.
Posted on December 8, 2006 @ 09:16 am
Cambridge Antibody Technology (CAT) has promoted three individuals to the management position of vice president.
Gaynor Fryers has been named vice president, business development and will be responsible for managing the company's business development activities. Ms. Fryers joined the company in 2004, and prior to her promotion, held the position of business development director. Before joining CAT, she worked as group commercial director at Bespak and held a number of business and commercial roles at Bio Products Laboratory (BPL).
Ian Anderson will serve as vice president, discovery - respiratory and inflammation. He will lead the respiratory and inflammation team within CAT's drug discovery department. Mr. Anderson joined the company in 1998 to establish the pharmacology group and previously worked at Glaxo Wellcome in a number of roles within the pharmacology and neuroscience departments.
Andy Williams, named vice president, discovery - program management, will lead the program management team within CAT's drug discovery department. He joined the company in 1993, following a post-doctoral fellowship at the University of British Columbia in Vancouver, and has led a number of CAT's drug discovery and technology development projects.
Hamish Cameron, chief executive officer at CAT, commented, "CAT's progression as a world-leading biopharmaceutical company is underpinned by the knowledge and expertise of our exceptional staff. These key promotions will strengthen and broaden the capabilities and experience of our team and we are delighted to recognize the expertise of these three individuals and their contribution to CAT's ongoing success."
Posted on December 7, 2006 @ 09:10 am
AC Immune, Ltd. has entered into an exclusive global license agreement and research collaboration with
Genentech for the development of anti-beta-amyloid antibodies for the potential treatment of Alzheimer's Disease (AD) and other human diseases. Beta-amyloid is an important target for disease-modification of AD and AC Immune has developed conformation-specific antibodies against this protein generated by its SupraAntigen Technology.
Under the terms of this agreement, Genentech will make an upfront payment with the potential for a total of more than $300 million upon successful completion of clinical and regulatory milestones for AD and additional applications. Upon commercialization of a product, Genentech will pay AC Immune royalties on net sales of AC Immune's antibodies in the field of AD or other human applications. Genentech will also provide funding for a multi-year collaborative research program and will cover all development and clinical costs of the lead antibody and subsequent antibody candidates.
"Out-licensing one of our lead programs to Genentech achieves a major business objective for the company and represents a significant milestone in the three-year history of AC Immune," said Andrea Pfeifer, chief executive officer of AC Immune. "Genentech is an excellent, and our preferred, collaborator for the antibody program due to its expertise in development and commercialization of antibodies."
Posted on December 7, 2006 @ 09:07 am
Immunicon Corp. has entered into a research agreement with
Eisai, Co. Ltd., funding biomarker development for certain proteins and their modifications associated with molecular targeted agents. Leon Terstappen, chief scientific officer of Immunicon, said, "We are pleased to work with Eisai on these important biomarkers. If successful, these proteins and their modifications will help to identify patients that may benefit from targeted therapies or to monitor treatment efficacy."
Byron D. Hewett, president and chief executive officer of Immunicon, commented, "We are pleased to add Eisai to our growing list of pharma partners. We now have research collaborations with partners in the U.S., Europe and Japan, all with the important goal of advancing the understanding of cancer and ultimately improving the lives of patients."
Posted on December 7, 2006 @ 09:04 am
Thomas O. Daniel, M.D. has been appointed president of
Celgene Research, responsible for leading the discovery, preclinical and early stage clinical programs for the company worldwide. Dr. Daniel has more than 20 years of medical and pharmaceutical research experience. He most recently served as the chief scientific officer at Ambryx, Inc., a biotechnology company focused on discovering and developing protein-based therapeutics. Prior to that, Dr. Daniel was vice president of research at Amgen, where he served as research site head for Amgen Seattle, as inflammation therapeutic area head, and on R&D portfolio review boards. Prior to Amgen's acquisition of Immunex, Dr. Daniel was senior vice president of discovery research at Immunex, where he consolidated and built programs in oncology and vascular biology.
"We are very pleased to welcome Dr. Daniel to Celgene," said Sol J. Barer, Ph.D., chief executive officer at Celgene Corp. "Dr. Daniel's extensive experience in oncology and immunology, coupled with a proven track record of building and leading research and development teams, provides us with valuable skills to advance our promising proprietary pipeline that embodies the future of Celgene."
Also,
David W. Gryska joined the company as chief financial officer and will lead the worldwide finance organization with responsibility for accounting and reporting, strategic planning and analysis, treasury, tax, audit, and corporate communications. Mr. Gryska has extensive business experience having served as a chief financial officer of public companies for more than 10 years, most recently at Scios Inc., a biopharmaceutical company that was acquired by Johnson & Johnson. Earlier in his career, Mr. Gryska spent 11 years at Ernst & Young where he rose to partner and was responsible for managing audit and consulting services for private and public held biotechnology and healthcare companies.
"We are very pleased to have David join our senior management team at Celgene during a period of such rapid growth where his business building skills and financial experience will contribute broadly to our finance, operations and global business strategy," said Dr. Barer.
Posted on December 6, 2006 @ 09:20 am
Akorn, Inc. and
Strides Arcolab Ltd. have agreed to fund, develop, and commercialize an additional 10 ANDA injectable drug products for their Akorn-Strides, LLC Joint Venture. The two companies created the JV in 2005 and have since submitted 15 ANDAs. Before the end of the year, the JV expects to submit two more ANDAs. Akorn-Strides is developing liquid, lyophilized and dry powder fill generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.
The additional funding for the Joint Venture will expand Akorn-Strides to 29 ANDAs for a total of 53 SKUs, or product line offerings. The JV expects to generate revenues in 2007 based on initial product approvals and subsequent product launches.
Arthur S. Przybyl, president and chief executive officer of Akorn and member manager of Akorn-Strides, LLC stated, "We are pleased with the progress of the Joint Venture since its inception. Strides Arcolab has demonstrated on-time execution in developing ANDA injectable drug products. Akorn has been filing regulatory submissions for the JV at a rate of approximately two per month. It stands to reason that expanding the product portfolio will only help to generate greater revenues and market presence."
Posted on December 6, 2006 @ 09:19 am
Ricerca Biosciences, LLC and the
Bicoll Group have signed a collaboration agreement that will combine their strengths in MedChem Services to offer solutions that streamline drug discovery and development. Ricerca has a network of business development representatives throughout the U.S. and it will leverage Bicoll’s medicinal chemistry and natural product chemistry technology for drug discovery to North American clients.
“We believe that the access to Bicoll’s unique natural product chemistry technology as well as its competence in supportive reporting and IP protection will further strengthen our broad portfolio as a successful solution provider for product and process development and testing services,” commented Thomas Bradshaw, chief executive officer of Ricerca. “Bicoll’s strong and reliable MedChem Services, conducted in China, will allow us to provide our clients with additional valuable support in drug discovery.”
“Joining forces, Bicoll and Ricerca will be able to provide high medicinal, natural product, and custom synthetic chemistry services with a competitive price range to their clients,” stated Dr. Kai Lamottke, general manager of Bicoll (Shanghai) Co. Ltd. “As a state-of-the-art R&D company for high-tech natural product chemistry and drug discovery, the Bicoll Group has experienced an intensive growth spurt over the past few years – with the strong marketing partnership of Ricerca within North America we will now be able to provide our services together not only to European pharmaceutical customers, but to clients worldwide.”
Posted on December 6, 2006 @ 09:17 am
Charles A. Rowland, Jr. has been appointed executive vice president, chief financial officer and treasurer,
Endo Pharmaceuticals Holdings, Inc. Mr. Rowland has more than 20 years of pharmaceutical industry experience, including senior-level positions at Pharmacia Corp., Novartis, Bristol-Myers Squibb and most recently as senior vice president and chief financial officer of Biovail Pharmaceuticals. In his new role, he will be responsible for all aspects of Endo's financial and accounting operations, as well as corporate communications.
"We are delighted to welcome an executive of Charlie Rowland's stature and abilities to Endo's senior management team," said Peter A. Lankau, president and chief executive officer. "He brings a successful track record that includes broad-based industry experience, keen financial and transaction acumen and an aligned strategic vision that we believe will benefit us as we enter the next phase of our growth." Mr. Rowland replaces Endo's former chief financial officer, Jeff Black, who retired in August.
The company has also promoted
David E. Kerr to senior vice president, commercial business, to head the sales and marketing efforts for the both branded and generic businesses.
Posted on December 5, 2006 @ 09:04 am
Intertek Group's Oil, Chemical and Agri division (Caleb Brett) has acquired
Alta Analytical Laboratories, Inc., a supplier of immunochemistry and LC/MS/MS bio-analytical services to the pharma and biopharma industries in North America. Alta has labs in San Diego and labs near Sacramento, CA with approximately 110 staff.
The acquisition is part of Intertek's strategic growth plan to support global pharma and biopharma industries by providing extensive method development capabilities and a range of state-of-the-art analytical testing services.
Intertek's executive vice president and chief executive officer of the Caleb Brett Division, Mark Loughead, commented, "Alta has earned an outstanding reputation for quality and service and its expertise will further expand our ability to respond to the needs of the pharmaceutical and biopharmaceutical industry for outsourced R&D and testing support. It establishes a firm platform for further development for Intertek in the U.S." Intertek currently provides testing services to clients from its laboratories in the UK.
Bob Bethem and Jo Smolec, Ph.D., the Alta Analytical Laboratory business heads, commented, "Acquisition by Intertek allows Alta the ability to invest in the next phase of expansion to grow our services and offer extended expertise to our existing clients. Becoming part of Intertek's global business and reach provides a powerful opportunity to expand our bio-analytical services to existing and new international customers and markets."
Posted on December 5, 2006 @ 09:03 am
Merck has initiated clinical development of a compound that was discovered as part of a funded research collaboration between Merck and
Isis Pharmaceuticals. Merck will pay Isis a $1 million milestone payment based on the initiation of clinical trials.
Isis' senior vice president of research, C. Frank Bennett, Ph.D., commented, "We're pleased to see Merck advancing this molecule in clinical trials. The compound was created out of our productive collaboration, which took advantage of Isis' expertise in nucleic acid therapeutics. We look forward to Merck's future progress with this compound."
Posted on December 5, 2006 @ 08:50 am
Celsis International is offering its rapid microbial detection capability as an outsourced service for pharmaceutical and consumer products companies. According to the company, the results -- presence or absence of microbial contamination -- are delivered in less than half the time as conventional agar methods, according to the company. Earlier identification of contamination allows for faster corrective action. The company's proprietary ATP bioluminescence technology offers speed and sensitivity that ensures detection of slow growing microorganisms even in the presence of non-microbial ATP.
Celsis Analytical Services, a Celsis division that provides contract chemical and biological science laboratory services, will use the company's rapid microbial detection technology to rapidly test samples for organisms in five days or less upon compound receipt. Results are sent electronically to customers for immediate notification of the presence or absence of yeast, molds or bacteria.
"Compared to traditional agar methods, rapid microbial detection means customers can release finished products faster and reduce their manufacturing lead times," said John Daniels, vice president of analytical services. "When contamination events do occur, earlier detection results in earlier containment and response."
Celsis Analytical Services has laboratory facilities in Edison, NJ, and St. Louis, MO. Both locations are FDA registered and operate under cGMP standards.
Posted on December 4, 2006 @ 09:36 am
Pfizer has stopped development of its cholesterol drug torcetrapib, due to safety concerns. According to the company, an independent safety board recommended the discontinuation of the clinical trial, Illuminate, because of an imbalance of mortality and cardiovascular events. Pfizer immediately terminated the entire development program for the drug. The product, which raises levels of "good" HDL cholesterol, was expected to be a major growth driver for the company, with sales potentially rivaling those of Lipitor, which will likely face generic competition by 2011.
"We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Dr. Philip Barter, chairman of the steering committee overseeing the Illuminate study and director of the Heart Research Institute in Australia.
Following the discontinuation of Torcetrapib, Pfizer's chief executive officer, Jeffrey Kindler, affirmed the financial forecast he gave recently, emphasizing the company's diverse portfolio of new drugs in the pipeline and the company's financial strength. "With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it. It is important to put this information in the context of both our commitment to transform Pfizer and our overall product and financial strength," Mr. Kindler said.
Posted on December 4, 2006 @ 09:27 am
ProMetic Life Sciences, Inc.'s UK subsidiary,
ProMetic Biosciences, Ltd. (PBL), has entered into an agreement with
Novartis Vaccines and Diagnostics to develop a synthetic-ligand affinity adsorbent for the purification of a recombinant protein vaccine. Under the terms of the agreement PBL will receive funding from Novartis to screen its Chemical Combinatorial Libraries for ligands suitable for the process scale purification of a new vaccine product by Novartis currently undergoing clinical trials. The work will be conducted at PBL's research laboratories at the Cambridge Science Park, UK. Financial details were not disclosed.
According to Dr. Steve Burton, chief executive officer of PBL, "We are proud to have been selected by Novartis for this exciting project. This latest agreement is further recognition of PBL's prominence and successful track record in the development of affinity ligand products for bioprocess applications."
Posted on December 4, 2006 @ 09:26 am
Karen L. Goldenthal, M.D. has joined
PharmaNet Development Group's consulting division as executive director, PharmaNet Consulting. "Dr. Goldenthal's in-depth knowledge of the clinical and regulatory aspects of vaccine development will bring additional strength and leadership to PharmaNet vaccine development services," commented James P. Burns, Jr., Ph.D, senior vice president, regulatory consulting worldwide.
Dr. Goldenthal joins the company from the FDA where she worked for more than 20 years. For the past 10 years, she was director of the division of vaccines and related products applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER). Dr. Goldenthal has been extensively involved in all aspects of vaccine development. She was responsible for providing input to senior management on regulatory policy and the review of clinical trials and clinical data to support licensure of vaccines. She has also worked with national and international committees and organizations on technical and policy issues related to vaccine development.
Posted on December 1, 2006 @ 08:49 am
Crucell N.V. has been awarded contracts totaling more than $230 million for its Quinvaxem and Hepavax-Gene pediatric vaccines by supranational organizations. The contracts cover the next three years and the awarded amount will increase during those three years.
Following the WHO prequalification in September 2006 the combination vaccine was made available to supranational purchasing organizations. These organizations are major customers for combination vaccines, which are used in large vaccination programs in developing countries.
Quinvaxem, a fully liquid pentavalent vaccine for children, was co-developed with Novartis Vaccines and Diagnostics and is produced in Crucell's laboratories in South Korea. The vaccine combines antigens for protection against five childhood diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b, one of the leading causes of bacterial meningitis and pneumonia in children. Current demand for the Quinvaxem vaccine exceeds 50 million doses.
The Hepavax-Gene, recombinant hepatitis B vaccine, is one of the WHO's pre-qualified vaccines for active immunization against the hepatitis B virus. Young children infected with HBV are the most likely to develop chronic infections. Hepavax-Gene was introduced in 1996 and is supplied to more than 90 countries.
"The multiple year contracts that the supranational organizations have granted to Crucell, underline Crucell's position as a leading supplier of important vaccines. Quinvaxem is the first internationally available fully-liquid vaccine containing these five life saving antigens and it will make a significant contribution to children's vaccination programs in the developing world," stated Crucell's chief executive officer, Dr Ronald H.P. Brus.
Posted on December 1, 2006 @ 08:44 am
Yuji Orihara has been appointed president and representative director,
Amgen KK, effective immediately. Amgen KK was formed in 1992 in Japan as a wholly owned subsidiary of Amgen, Inc. Mr. Orihara will be responsible for all aspects of the company's commercial efforts in Japan and will be based at the Amgen KK headquarters in Tokyo.
Amgen is building Amgen KK to become a full commercial operation and a growing clinical research operation. During the next several years, the company's commercial operations in Japan are expected to expand as it prepares for the potential launch of its late-stage pipeline products. Amgen expects to increase its staff in Japan to more than 300 by 2009.
"Yuji's significant experience in Japan's pharmaceutical industry make him exceptionally qualified to meet the challenges of achieving our goal of bringing Amgen's vital medicines to patients in Japan," said George Morrow, executive vice president, Global Commercial Operations. "I am confident that he will prove a strong leader and a collaborative partner within Amgen's global operations to ensure organizational success."
Mr. Orihara joins the company from Novartis Pharma K.K. where he most recently served as senior managing director in charge of the oncology, transplantation/immunology/infectious diseases, and ophthalmic business units. He also led business development and licensing as well as market access and public policy for Novartis Japan. Prior to Novartis, Mr. Orihara was the president of UCB Japan where he was successful in building a significant sales force and commercializing a series of products that yielded revenues in excess of $300 million.
November 2006
Posted on November 30, 2006 @ 08:39 am
Cardinal Health plans to divest its Pharmaceutical Technologies and Services (PTS) segment, a business that manufactures or packages 100 billion doses of medication annually for pharma and biopharma firms. The segment employs approximately 10,000 people at more than 30 facilities worldwide and generates $1.8 billion in revenue.
"In the coming years, Cardinal Health will focus more on our products and services that help providers improve the safety and productivity of health care," said R. Kerry Clark, president and chief executive officer of Cardinal Health. "While synergies clearly exist between PTS and our other businesses, we believe there is greater customer and shareholder value in the expansion of our supply-chain and medical and clinical products businesses domestically and internationally. These segments align with our core competencies and customers, and we see significant opportunities for future growth and improved return on capital."
According to the company, the decision was made to focus its capabilities and resources to better serve health-care provider customers, such as hospitals and pharmacies. The company expects to use the proceeds to repurchase Cardinal Health shares. The company plans to continue to invest in organic growth and acquisitions to strengthen existing product and service offerings.
Cardinal Health will retain Martindale and Beckloff Associates, two businesses that support the generic pharmaceutical market. Martindale develops generic, intravenous medicine that is complementary to Cardinal's hospital business and generics strategy. Beckloff provides regulatory consulting services, including for Cardinal's generic products. Combined, these businesses have approximately 400 employees at two primary locations in the U.S. and UK.
Posted on November 30, 2006 @ 08:29 am
AAIPharma, Inc. and
Mallinckrodt Pharmaceuticals Outsourcing have established a pharmaceutical outsourcing alliance in order to deliver worldwide complementary services from drug development to high-volume commercial manufacturing. The two companies will work together to provide a one-stop drug development solution for the pharma and biopharma industries.
AAIPharma has expertise in analytical development, formulation development, bioanalysis and clinical trials. Mallinckrodt has capabilities in technical transfer for manufacturing scale-up and full-scale commercial production. Together, the two companies plan to create value for customers by utilizing collective scientific and development skills.
“Our extensive capabilities in manufacturing management coupled with AAIPharma’s long-standing strength will bring exceptional service and value to a broad spectrum of pharmaceutical companies,” said Vince Kaiman, vice president and general manager of Mallinckrodt Pharmaceuticals, a division of Tyco Healthcare.
“We are delighted to be collaborating with Mallinckrodt,” stated Vito Mangiardi, AAIPharma president of North American Operations. “This alliance significantly strengthens our ability to meet the commercial manufacturing needs of our customers worldwide. Combining AAIPharma and Mallinckrodt’s expertise will create competitive advantages for both companies and expand respective business opportunities.”
Posted on November 30, 2006 @ 08:27 am
Alcan will invest $27.5 million to expand its pharma center in Shelbyville, KY. The Shelbyville center is dedicated to pharmaceutical flexible packaging materials. The expansion is expected to be operational by February 2008.
“This investment demonstrates Alcan’s ongoing effort to anticipate its customers' expanding needs and to deliver the highest value added products and services,” said Michael Rubenstein, president, Alcan Global Pharmaceutical Packaging. “This expansion will provide additional capacity that will meet the projected growth in the North American pharmaceutical packaging industry over the coming years,” added Mr. Rubenstein.
The expansion will include the installation of a laminator, eight color gravure printing press, slitter, clean room, finishing/packing complex, warehouse facility and cure room. The project will create 40-50 new positions at the facility, which currently employs approximately 150 people.
Posted on November 29, 2006 @ 09:17 am
Auxilium Pharmaceuticals, Inc. has amended its manufacturing agreement with UK-based
Cobra Biologics, Ltd. Under the amended agreement, Cobra will complete one BLA batch of the active ingredient for AA4500, the company's injectable enzyme. The revised agreement is a result of Auxilium's decision to move forward with its facility in Horsham, PA to support the BLA submission and to serve as a primary source of the commercial supply of AA4500.
Auxilium will use the materials in ongoing and future clinical trials for AA4500 for the treatment of Dupuytren's contracture and other indications. The companies agreed to continue their collaboration related to the technology transfer, ongoing stability programs and other services provided by Cobra.
"This amendment allows our manufacturing, quality assurance and development teams to focus on getting the Horsham facility ready for the BLA submission expected at the end of 2007," said Mr. Armando Anido, Auxilium's chief executive officer and president. "The amendment also ensures that Cobra will continue to provide technology support and be involved as a development partner for this critical asset. We look forward to continuing our collaboration with the Cobra team."
Posted on November 29, 2006 @ 09:15 am
Millennium Pharmaceuticals, Inc. initiated a randomized, double-blind, placebo-controlled Phase II study of MLN3897 in patients with rheumatoid arthritis (RA). MLN3897, an oral, small molecule designed to block CCR1, is a chemokine receptor believed to play a role in inflammatory disorders including RA.
The study will assess the efficacy, safety and tolerability of MLN3897 in combination with methotrexate (MTX), a standard therapy for RA. As many as 186 patients with RA that have been taking MTX for at least six months prior to screening will be enrolled in the study. Patients will continue the MTX regimen and will receive MLN3897 or placebo. The primary endpoint of the study is ACR20 response rate, a standard clinical measurement for RA, which measures improvement in the number of tender and swollen joints and various levels of disease activity.
Posted on November 29, 2006 @ 09:13 am
ImpactRx, Inc. has named
Richard C. Altus president and chief executive officer. Mr. Altus served as president and acting chief executive officer since May of this year. Per Lofberg, chairman of ImpactRx’s board of directors and president of Merck Capital Ventures, an investor in ImpactRx, stated, "During his first six months on the job, Rich has proven to be an effective leader and has continued to build on the company's successes. He has established a clear strategic direction for the company and has made real progress in ensuring that the organization executes its business objectives. This action by the board to fully endorse him as president and chief executive officer is confirmation of our confidence in Rich’s ability to lead ImpactRx into the future."
Mr. Altus, who joined the company in 2002, has more than 25 years of financial and management experience in both private and public companies. Prior to his current position, he was the company’s chief financial officer. Before joining the company, he served as chief operating officer for Medical Broadcasting Company, a company that was an innovator in the use of online and e-marketing techniques for the pharmaceutical and biotechnology industries.
Posted on November 28, 2006 @ 09:24 am
Baxter Healthcare Corp. has expanded lyophilization capacity at its Halle, Germany facility to support the growth of its Baxter BioPharma Solutions (BPS) cytotoxic contract manufacturing business. Two large-scale lyophilization chambers will be added to freeze-dry cancer therapies for its pharma and biopharma partners. The expansion will be complete and fully validated by mid-2007.
"We are expanding to meet the growing demands of the cytotoxic manufacturing market," said Tom Polen, senior director of marketing for BPS. "As a leader in the industry, we look forward to providing greater capacity and continuing to advance our track record for delivering safe, high-quality products for our customers."
The lyophilization chambers, which will include technologies such as handling of organic solvents, will be designed to optimize product quality and safety to ensure product integrity. An automated vial loading system and new in-process quality analysis technology will provide advanced control over the manufacturing process to help ensure the highest quality product is produced.
Posted on November 28, 2006 @ 09:22 am
Dr. Joseph Chiesa, former European director of clinical research for
Covance, has re-joined the company as medical director of its Leeds, UK clinical research facility. Dr. Chiesa has 30 years of pharmaceutical industry experience and in-depth knowledge of the CRO industry. He spent the last eight years in CRO management positions with Pharm-Olam, Intercern, Chiltern, Kendle and Veeda Clinical Research, in addition to Covance. He also held management roles of increasing responsibility in the pharmaceutical industry, most recently with Astra Zeneca.
Posted on November 28, 2006 @ 09:20 am
Cytokinetics, Inc. has amended its collaboration and license agreement with
GlaxoSmithKline (GSK), under which Cytokinetics will assume responsibility for the costs of continued development of the kinesin spindle protein (KSP) inhibitors ispinesib (SB-715992) and SB-743921, subject to GSK's option to resume responsibility for some or all development and commercialization activities associated with each of these novel drug candidates.
Under the revised terms of the agreement, Cytokinetics will develop a program for ispinesib designed to supplement Phase I and Phase II trials sponsored by GSK that have shown promise in the treatment of metastatic breast and lung cancers and that have shown a tolerability profile for ispinesib in combination with standard chemotherapeutics. Cytokinetics plans to conduct trials in breast cancer patients in 2007. This program would be designed to further define the clinical activity profile of ispinesib in advanced breast cancer in preparation for a Phase III trial of ispinesib for the second-line treatment of advanced breast cancer. Currently, The National Cancer Institute (NCI) is conducting Phase II and Phase I trials with ispinesib and Cytokinetics is conducting a Phase I/II trial of SB-743921 in non-Hodgkin's lymphoma (NHL).
"We are pleased to have the opportunity to sponsor additional activities focused to advancing ispinesib as a potential next-generation approach for the treatment of breast cancer alongside our ongoing clinical trial now underway with SB-743921," stated James H. Sabry, M.D., Ph.D., Cytokinetics' chief executive officer. "We believe that the clinical trials data generated by GSK, alongside data arising from NCI sponsored trials, should serve as a foundation for a focused and cost effective development program going forward."
Posted on November 27, 2006 @ 10:34 am
Genzyme Corp. has begun treating patients in a Phase II trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. This is Genzyme's second pivotal clinical study of Clolar in adult patients with AML to commence this year, and it is expected to provide substantial support for expanding the current product label.
"We are very pleased to begin treatment in this clinical study as we seek to expand Clolar therapy to adult patients," stated Mark Enyedy, senior vice president and general manager of Genzyme Oncology. "Significant data from investigator-sponsored clinical trials have already been presented regarding the use of Clolar in adult AML and show very encouraging results. The start of this new clinical study is another important step in our plan to broaden Clolar's label to benefit a larger patient population and address multiple lines of adult AML."
The trial is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the U.S. The median survival for those receiving therapy can vary from one to thirteen months, and the five-year survival rate over the past three decades remains at less than 15 percent. Standard therapy is poorly tolerated and early induction mortality exceeds 30 percent in patients with poor risk factors.
Posted on November 27, 2006 @ 10:31 am
ATMI LifeSciences and
Artelis have announced agreements to focus on the commercialization and distribution of Artelis’ proprietary disposable mixing technology integrated with ATMI’s proprietary film technology, and to jointly develop, test and manufacture single-use bioreactors/fermentors.
The agreements will leverage ATMI LifeSciences' expertise in advanced ultra-clean film manufacturing and single-use mixing technology with Artelis' knowledge of the cell culture process, fermentation applications and disposable bioreactors to provide customers with higher performance in purity, precision and process efficiency in the manufacture of advanced biopharmaceuticals.
ATMI LifeSciences Managing Director, Mario Philips, said: "Our initial focus has been to establish our scalable contained powder and liquid single-use mixing technologies. Now, through our alliance with Artelis we are completing our single-use mixing product offering for scalable liquid-to-liquid mixing applications. Artelis' mixing technology is more advanced than the recirculation pump and magnetic mixer liquid-to-liquid mixing systems currently available in the marketplace. This enables us to have suitable mixing product offerings across all bioprocess applications for our customers."
Posted on November 27, 2006 @ 10:27 am
Schering-Plough Corp. has appointed
Thierry Powis as president director, P.T. Schering-Plough Indonesia Tbk. Mr. Powis will be responsible for leading the company's pharmaceutical business in Indonesia and will be based in Jakarta. He will report directly to
Ashley Morris, area director, South Asia.
Mr. Powis brings more than 25 years of experience in the pharmaceutical industry gained in Europe, North America and Asia. Most recently, he held a consultant position with Sofco, a software development company, based in Jakarta. Previously, he served in positions of increasing marketing and sales responsibility with Sandoz in Belgium and Canada and as managing director in Thailand. For the past 10 years, he has worked in Indonesia as managing director for Bayer, market company president for Pharmacia, and general manager for Sanofi-Synthelabo.
Posted on November 22, 2006 @ 08:57 am
Pfizer and
Teva Pharmaceutical Industries have settled a patent litigation regarding Teva's sale of generic versions of Pfizer's Zithromax antibiotic and Idamycin cancer drug. Under the agreement, Teva will pay Pfizer as much as $70 million and will continue to market its generic versions of the two drugs. The settlement also includes an option for Teva to sell its generic version of another cancer drug, epirubicin, prior to the August 2007 patent expiration, according to a Pfizer statement.
Posted on November 22, 2006 @ 08:33 am
The Austrian Ministry of Health has entered into a preparedness contract with
Baxter Healthcare SA, a subsidiary of Baxter International, for an option to purchase 16 million doses of pandemic influenza vaccine. The three-year agreement provides the Austrian MOH with future access to the company's cell-based vaccine production capacity in the event of an avian flu pandemic.
"We are proud to provide the advanced science and technology, manufacturing capability and other resources to assist the Austrian Ministry of Health in its efforts to protect citizens from the threat of a flu pandemic," said Joy Amundson, corporate vice president and president of Baxter's BioScience business.
Baxter is also under contract to supply two million doses of H5N1 vaccine to the UK Government. The company is also working with the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop a cell culture-based H5N1 candidate pandemic influenza vaccine.
Baxter's preliminary results of a Phase I/II trial in 270 adults with its inactivated wild-type H5N1 pandemic vaccine suggested that the vaccine is well tolerated in humans. Results also suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level. These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic.
Posted on November 22, 2006 @ 08:29 am
Roche will discontinue its agreement with
PDL BioPharma, Inc. for the development and commercialization of daclizumab for organ transplant patients on longer-term maintenance therapy. This decision follows an internal review of its development programs. Earlier this year, Roche discontinued its involvement in the co-development of daclizumab for the treatment of asthma. The agreement between the two companies will end in May 2007.
PDL will hold exclusive development and commercial rights to daclizumab for transplant maintenance and asthma indications, both of which have shown potential based on earlier clinical trials. In a separate collaboration, Biogen Idec and PDL are developing daclizumab in multiple sclerosis and other indications.
"We are evaluating the overall transplant maintenance indication opportunity for daclizumab, while we continue to support the ongoing studies of daclizumab in relapsing/remitting multiple sclerosis, and anticipate results from the Phase II study during 2007," said Mark McDade, chief executive officer, PDL BioPharma. "In the meantime, efforts are ongoing to evaluate partnership opportunities for this important drug in asthma."
Posted on November 21, 2006 @ 08:39 am
Almac Pharma Services are extending their formulation facilities with the opening of a refurbished 10,500-sq.-ft. building at the company’s UK headquarters. The company invested $10.5 million to strengthen its offering to the global pharma and biopharma industries.
The custom-designed facility will operate to full cGMP, providing extended formulation development services in solid oral dosage forms from pre-clinical through to pilot scale. This advancement will provide classified facilities (ISO 8 / Class 100,000) including labs with independent temperature and humidity controlled zones and self-contained suites—many with high containment capabilities.
Graeme McBurney M.D., Almac Pharma Services president, said the investment represents a significant element of the overall future growth strategy of Pharma Services. “We at Almac Pharma Services are entering into a new and exciting phase in our development. We are investing to expand the breadth and depth of an already comprehensive suite of commercial services. We work with an increasing number of clients, supporting their needs at each stage of the drug product life cycle, including formulation development, clinical batch production, commercial scale manufacturing, packaging and global supply chain management.”
Posted on November 21, 2006 @ 08:35 am
Albany Molecular Research, Inc. (AMRI) has made leadership changes following the restructuring of its large scale manufacturing facility in Rensselaer, NY.
Steven R. Hagen, Ph.D. has been promoted to vice president for quality and analytical chemistry and
Paul F. Vogt, Ph.D. has been promoted to director of manufacturing.
Dr. Hagen will be responsible for overseeing analytical and quality functions at all of AMRI's facilities. He will also be responsible for the company's regulatory activities, including the company's relationship with the FDA. Dr. Hagen was previously senior director of analytical quality services, where he supervised the company's analytical chemistry team, which measures the chemical purity and physical properties of drugs as they move through the drug development and manufacturing process. He joined the company in 2005 from his previous position as director of analytical R&D at Pfizer's Global R&D Division in Kalamazoo, MI. He joined Pfizer in 1994 as a research scientist. Prior to Pfizer, he was an analytical biochemist with Ribi ImmunoChem Research, Inc.
In his new role, Dr. Vogt will be responsible for the manufacturing of all bulk chemicals, pharmaceuticals and intermediates at the company's Rensselaer facility. He will oversee all compounds manufactured for human clinical trials and commercial products. Dr. Vogt joined the company in 1997 as a senior research chemist and has since held positions of increasing responsibility. He was promoted in 2005 to director of chemical development, where he oversaw the company's chemical development activities, including managing customer projects and project teams involved in process research and scale-up activities.
"We are pleased to announce the promotions of Drs. Hagen and Vogt into these leadership roles at AMRI," said AMRI chairman, chief executive officer and president Thomas E. D'Ambra, Ph.D. "These promotions occur as part of the restructuring of our large scale manufacturing operations. Steve and Paul each have managed areas of our business that have been bright spots performance-wise in the recent past. I am confident, as they bring their skills to their increased responsibilities, that AMRI has the right people in place to position our manufacturing operations for long-term growth and profitability. We are pleased to announce these changes and wish Steve and Paul continued career growth and success."
Posted on November 21, 2006 @ 08:30 am
Crucell has signed an agreement to acquire Stockholm-based
SBL Vaccin AB (SBL) from 3i and SEB for $50.6 million in cash. The acquisition is expected to close on November 23, 2006.
SBL is an independent Swedish biotechnology company employing 120 people. SBL's main product is Dukoral, an oral vaccine for protection against cholera and is registered in more than 50 countries excluding the U.S. Dukoral is also registered in the same countries (excluding the EU and Australia) to protect against ETEC (travelers' diarrhea). In 2005 sales were $16.6 million. SBL also has a sales and distribution organization for vaccines in Scandinavia where the company markets vaccines sourced from global vaccine companies including Crucell. Revenues related to the distribution of third party products were approximately $13 million in 2005.
"The acquisitions of SBL and recently acquired Berna Products Corp., both fit perfectly in our strategy to further expand our travel vaccines portfolio," said Crucell's chief executive officer, Ronald H.P. Brus. "We now have access to 'best in class' marketing and sales capabilities, which we will use to accelerate future sales growth and support new product launches."
Posted on November 20, 2006 @ 09:17 am
Hospira,
Stada Arzneimittel AG, and
Bioceuticals Arzneimittel AG, a Stada-initiated company focused on biosimilar products, have entered into a development, manufacturing and distribution agreements for a generic version of erythropoietin (EPO). Erythropoietin is a naturally occurring protein hormone produced by the kidney. Therapeutic erythropoietin is used to treat anemia in dialysis and in certain oncology applications.
"Developing and providing access to biosimilars is a natural extension of Hospira's leadership position in generic injectable pharmaceuticals and an important part of our strategy of investing for growth," said Christopher B. Begley, chief executive officer, Hospira. "The collaboration will help expand the availability of a more cost-effective alternative to EPO medications currently on the market, furthering our ability to take additional costs out of the global healthcare system."
Through the agreement, Hospira obtains exclusive distribution rights for Bioceuticals' erythropoietin in the EU and several other European countries. Hospira will retain exclusive distribution rights in the U.S. and Canada, where it will also be responsible for the development and manufacture of the product. Hospira holds a first right of refusal for the distribution rights in all other countries. Bioceuticals will receive a $21 million upfront payment, as much as an additional $34 million in payments based on meeting specified objectives, and royalty payments on commercial sales.
Bioceuticals has submitted a marketing application for a biosimilar erythropoietin to the EMEA for a dialysis indication. The company is currently conducting trials in support of an oncology indication. Due to later patent expirations, a U.S. launch of the product is not expected for several years.
Posted on November 20, 2006 @ 09:15 am
Memory Pharmaceuticals Corp. earned a milestone payment of $960,000 from the
Stanley Medical Research Institute (SMRI) based on progress of an ongoing Phase IIa trial of MEM 1003 in patients with acute mania in bipolar disorder.
"We are pleased to have earned our first milestone payment from SMRI, and we are particularly pleased by enrollment in this trial to date," said Stephen R. Murray, M.D., Ph.D., vice president of clinical development. "We have increased the number of subjects in the trial from 60 to 80 to improve the power of the trial to detect the effect of MEM 1003 on the mood swings characterized by this disorder. We continue to look forward to completing this trial in the near future."
The multi-center, double-blind, randomized, placebo-controlled study is evaluating the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder. Subjects are being randomized to receive MEM 1003 or placebo for a 21-day treatment period, which will be followed by an optional open-label four-week treatment period. The primary outcome measure of the trial is the change in the Young Mania Rating Scale (YMRS) at 21 days.
Under the terms of the agreement, Memory could receive as much as $3.2 million from SMRI to fund its Phase IIa trial of MEM 1003 in bipolar disorder. Memory is eligible to receive as much as an additional $1.3 million of funding from SMRI upon the achievement of further milestones related to this trial. All of the milestone payments will be repayable to SMRI in the form of royalties on any future sales of MEM 1003 for the treatment of bipolar disorder or schizophrenia.
Posted on November 20, 2006 @ 08:58 am
ICON has selected
Sparta Systems' TrackWise as its enterprise tool for managing global quality requirements, with initial implementation of the system focused on internal, external, and supplier audits, as we well as Corrective and Preventive Action (CAPA) management.
TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool for electronically managing, tracking, and trending quality and regulatory issues and action items across the enterprise.
"ICON utilized a formal evaluation process, which initially included sending out detailed requests for proposals to several vendors," commented Josephine Coyle, vice president of corporate quality assurance at ICON. "The selection team chose TrackWise, based on the system's flexibility and Sparta's proven experience in the life sciences industry. We felt that Sparta and TrackWise provided the best long-term solution to meet our needs."
"The TrackWise system will act as a central repository for quality information and will enhance efficiency by enabling more proactive use of company resources," stated Graeme Pluves, account executive, for Sparta Systems Europe. "The system is designed to facilitate process harmonization, providing users with valuable, real-time information to support business objectives."
Posted on November 17, 2006 @ 08:50 am
Altus Pharmaceuticals, Inc. has signed a long-term agreement with
Lonza Group Ltd. for the commercial manufacture of its ALTU-135 drug substances at Lonza's facility in Kourim, Czech Republic. ALTU-135 is an orally administered enzyme replacement therapy in development for patients with pancreatic insufficiency. The drug product that results after blending three drug substance enzymes: protease, lipase and amylase. This combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals and to promote and maintain proper digestion.
Altus plans to initiate a Phase III trial of ALTU-135 in the 2Q2007. Altus will use its current contract manufacturer for the drug substances to be used in the trial. In preparation for the commercial launch of ALTU-135, Altus and Lonza will coordinate the technology transfer as well as the installation and qualification of the equipment necessary for the production of the drug while the Phase III trial is being conducted.
"We are pleased to be collaborating with Lonza, which is an organization with significant expertise in biopharmaceutical production, microbial fermentation, process optimization and quality systems," commented Sheldon Berkle, president and chief executive officer of Altus. "We believe selecting Lonza is a significant milestone for the ALTU-135 program. We continue to work towards putting the pieces in place for a successful ALTU-135 commercial launch."
Lonza's chief executive officer, Stefan Borgas, said, "Lonza is gratified to be partnering with Altus Pharmaceuticals and to be awarded this significant manufacturing agreement. We believe this relationship will significantly benefit both organizations and will ultimately result in a valuable therapy for patients in need."
Posted on November 17, 2006 @ 08:48 am
Wyeth has elected
Robert E. Landry, Jr. to the position of treasurer, effective January 1, 2007. Mr. Landry joined the company in 1988. In 2004, he was appointed chief financial officer of Wyeth Pharmaceuticals in Australia and New Zealand. In 2006, he was promoted to director, sales and marketing, Wyeth Australia. He succeeds Jack O'Connor, who will become executive vice president global finance and information services, Wyeth Consumer Healthcare.
Posted on November 17, 2006 @ 08:48 am
Genentech received approval from the FDA for Herceptin, a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment -- surgery with or without radiation therapy -- with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.
The approval was based on data from an interim joint analysis of more than 3,500 patients in two Phase III trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52% in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.
After 3.5 years in the study, 87% of women treated with Herceptin plus chemotherapy were disease free, compared to 71% of women treated with chemotherapy alone. A survival analysis conducted after an average of 24 months showed a 33% reduction in the risk of death, or a 49% improvement in overall survival.
Posted on November 16, 2006 @ 09:06 am
Advinus Therapeutics, Ltd. and
Merck have formed a drug discovery and clinical development collaboration in the area of metabolic disorders. The two companies will work together to develop clinically validated drug candidates for metabolic disorders, with Merck retaining the right to advance the most promising of these candidates into late-stage clinical trials.
Advinus will receive an upfront payment and could potentially receive milestone payments of as much as $74.5 million for each target included in the collaboration. Advinus is also eligible for royalties on the sales of any products that result from the collaboration. The collaboration will begin with two target programs, and could expand to include others.
"This collaboration provides an avenue for Advinus to gain access to cutting-edge technologies from Merck while leveraging its India-based discovery and development capabilities," said Dr. Rashmi Barbhaiya, chief executive officer and managing director of Advinus. "Importantly, this agreement also reflects India's emerging role in bringing innovative and life-saving drugs to market with speed and cost-effectiveness."
Merv Turner, Ph.D., senior vice president, worldwide licensing and external research at Merck, said, "Merck is looking forward to establishing its first research-based collaboration in India with Advinus. This agreement furthers our strategy of building global alliances and our commitment to discovering and developing innovative medicines for metabolic disorders, a growing public health issue."
Posted on November 16, 2006 @ 09:04 am
Parexel Consulting has expanded its risk management and strategic compliance expertise with the appointment of
Raymond T. Oji to the position of senior consultant. Formerly a microbiologist and consumer safety officer in the FDA San Francisco District, Mr. Oji has 40 years of experience in performing pharmaceutical inspections and drug and device analyses. He joins a global network of consultants dedicated to addressing risk management challenges.
"Parexel Consulting integrates scientific and regulatory compliance expertise with business performance expertise, represented by consultants such as Ray. Clients turn to our experts to help them respond rapidly and effectively to regulatory actions and avoid potential problems that could negatively impact business performance. Our goal is to help clients proactively assess and prevent risks to ensure successful product development and business outcomes," said Kurt Brykman, president of Parexel Consulting and Medical Communications.
Mr. Oji's background as a consumer safety officer and microbiologist with the FDA included conducting GMP and pre-approval inspections and audits worldwide of pharmaceutical manufacturing facilities in the areas of aseptic filling and processing, terminal sterilization, APIs and OTC drug production, as well as auditing pharmaceutical microbiology and chemistry laboratory operations. Mr. Oji also developed and performed analytical procedures and managed clean room operations, serving as a principal analyst for testing sterile drugs and devices. He has performed the full range of procedures for drug and device analyses including sterility, endotoxin, bioburden, microbial limits, water and environmental monitoring.
Posted on November 16, 2006 @ 09:01 am
Boston Scientific Corp. has appointed
Brenda Becker senior vice president of global government affairs. She will be responsible for managing the company's global government affairs and its corporate public policy and political action committee. Ms. Becker will report to
Paul LaViolette, chief operating officer.
"We are extremely pleased to have someone of Brenda's talent and distinguished reputation leading our government affairs function," said Mr. LaViolette. "She brings an outstanding track record of success to Boston Scientific with more than 20 years of governmental experience working in the nation's capitol."
Ms. Becker is currently assistant to the vice president for Legislative Affairs where she is responsible for advising the vice president of the U.S. and senior White House staff on legislative strategy in the House and Senate. Previously, Ms. Becker was assistant secretary for Legislative and Intergovernmental Affairs for the U.S. Department of Commerce, where she provided advice and counsel to the Secretary of Commerce and other senior Commerce officials on Congressional and intergovernmental affairs issues. Prior to that, she was vice president for Congressional Communications at the Blue Cross and Blue Shield Association.
Posted on November 15, 2006 @ 09:11 am
Bristol-Myers Squibb Co. has promoted
Andrew Bonfield, chief financial officer, and
Elliott Sigal, M.D., Ph.D., chief scientific officer, to executive vice presidents of the company. They join Lamberto Andreotti, president, worldwide pharmaceuticals. Mr. Andreotti leads global pharmaceuticals operations, as well as technical operations and global marketing at the company.
Mr. Bonfield will continue to lead global finance and strategic planning and issues management. Dr. Sigal continues his leadership of the Pharmaceutical Research Institute (PRI), the R&D arm of the company.
"Andrew and Elliott have played critical roles in the execution of the corporate strategy," said James M. Cornelius, chief executive officer, BMS. "Andrew has delivered superior oversight of the company's financial and operating performance, and was instrumental in integrating compliance throughout the company with new requirements under the Sarbanes-Oxley Act. Under Elliott's leadership, the PRI has delivered eight new product approvals in fewer than four years. This is outstanding performance by any measure."
Mr. Bonfield previously served as director of finance at the BG Group, PLC, an international energy company. Prior to that, he was chief financial officer at SmithKline Beecham -- now GlaxoSmithKline -- responsible for all aspects of the company's finances, including corporate control, operations, finance, tax, strategy and development.
Dr. Sigal has held senior positions in both discovery and development in the PRI, joining the company nearly 10 years ago to start its genomics department. As chief scientific officer, he achieved five new product approvals: Orencia, Sprycel, Baraclude, Emsam and Atripla. As senior vice president of clinical development, he secured the approvals of Abilify, Erbitux and Reyataz.
Posted on November 15, 2006 @ 09:09 am
Xceleron and
Covance have entered a co-promotional agreement in which both companies will make available their drug development services to customers. The two companies will carry out joint projects on behalf of sponsors and further the development of new applications.
Xceleron chief executive officer, professor Colin Garner, said, "This is a strategically important deal for Xceleron. It demonstrates how quickly our technology has moved from being seen as novel and at the edges of drug development to its acceptance as a mainstream part of the drug development process. Covance is a great partner to have and this agreement will add global marketing power to our business. We look forward to working closely with them."
Scott Tarrant, Xceleron’s vice president of business development, commented, "Covance is a well known service provider to U.S. pharma and biotech companies. The recent expansion of Covance’s Phase I capabilities mean that our customers will have enhanced support to conduct accelerated clinical trials and improve the efficiency of their drug development processes."
Posted on November 15, 2006 @ 09:07 am
Kendle has appointed
Sylva H. Collins, Ph.D. to vice president, global biometrics. Dr. Collins will oversee the company's biometrics services, which include clinical data management, biostatistics and scientific programming. She will also provide leadership for data centers in the U.S., Europe, Australia and Mexico staffed by more than 500 associates. She will serve on the company's management committee and will be based out of Kendle's headquarters in Cincinnati. Dr. Collins has scientific and management expertise, and is a recognized thought leader in the Electronic Data Capture (EDC) field.
"We are extremely pleased to welcome Dr. Collins to Kendle. Her forward thinking and proven leadership will keep Kendle's Biometrics services at the forefront of the industry," said Christopher Bergen, president and chief operating officer. "Her nearly three decades of experience in drug development and her extensive EDC experience will be significant assets as we continue to execute against our 'Kendle 500' global growth strategy."
Dr. Collins joins the company from Novartis Corp., where she served most recently as vice president, global advanced clinical systems, and vice president, global electronic data management. In these positions, she implemented and led the global data management operations for more than 400 EDC studies involving approximately 130,000 patients and 16,000 investigator sites on six continents.
Posted on November 14, 2006 @ 09:07 am
Eisai, Inc. has broken ground for a production and formulation R&D facility for parenteral oncology treatments in Research Triangle Park (RTP), NC. Eisai has a number of drugs in development for patients with cancer and recently entered the market through the acquisition of four oncology-related products from Ligand Pharmaceuticals.
Eisai will invest $90 million in the 65,000-sq.-ft. facility, which will have aseptic processing suites, labs and other support functions. A separate $15 million central utilities building is planned to supply power, steam, chilled water and compressed air to existing and new operations. Operations are expected to begin in 2009, leading to 59 new jobs during the next three years and a total of 84 new jobs in the next five years.
The new facility will support the existing 190,000-sq.-ft. facility, which is devoted to manufacturing Aricept and Aciphex tablets and to formulation R&D and manufacturing of compounds for use in clinical trials.
"The solid growth of the company, which includes an oncology pipeline, has led us to expand our presence in North Carolina for the third time since 2001," said Lou Arp, vice president, production operations, Eisai. "The new facility is a tribute to our successful history and future plans for production expansion, as well as our commitment to providing a stable supply of high-quality medicines."
Posted on November 14, 2006 @ 09:05 am
Abbott received approval for an expanded indication for Humira that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). Humira is also approved in the U.S. for use in moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis (AS).
PsA is a chronic disease that combines symptoms of arthritis, including joint pain and inflammation, and those of psoriatic skin disease, such as painful, raised red lesions covered by silvery white scales. Approximately one million people suffer from PsA in the U.S.
Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. Patients were randomized to receive either HUMIRA 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week open-label extension.
Posted on November 14, 2006 @ 09:03 am
CuraGen Corp. and
TopoTarget have initiated patient dosing in a Phase II trial evaluating the antitumor activity of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of ovarian cancer. The National Cancer Institute (NCI) is sponsoring this trial through an agreement with CuraGen for PXD101.
The Phase II trial is an open-label study of patients with either advanced platinum resistant ovarian tumors or micropapillary/borderline low malignant potential (LMP) ovarian carcinoma. Patients will receive intravenous PXD101 daily for five days in three-week cycles until disease progression. The primary endpoint for the study is the determination of objective disease response, as evaluated by the RECIST criteria. Secondary endpoints include safety and tolerability of PXD101, stable disease rates, duration of response, progression-free survival and median and overall survival.
Posted on November 13, 2006 @ 07:19 am
Neurogen Corp. has begun a Phase I trial for its leading drug candidate for treatment of obesity. The compound, NGD-4715, works as an antagonist at the melanin concentrating hormone receptor-1 (MCH1).
William H. Koster, president and chief executive officer, said, "We are extremely pleased to be entering human testing exploring this promising new target. While the MCH1 mechanism has been a target of high interest in the pharmaceutical community, we believe most in the industry have encountered significant obstacles to advancing drug candidates into human studies. Neurogen has established a leading position in this promising new arena and we hope to provide an effective therapeutic for the growing number of patients affected by obesity and its many co-morbidities, including diabetes and hypertension."
The Phase I trial is a randomized, double-blind, placebo-controlled evaluation in healthy overweight and obese subjects of the safety, pharmacokinetics, and pharmacodynamics of single rising oral doses of NGD-4715. The study will include 84 male and female subjects. This study will be conducted in the U.S. and standard safety assessments will be made.
Posted on November 13, 2006 @ 07:17 am
Medarex, Inc. expects to receive an undisclosed milestone payment from its licensing partner, Amgen Inc., for the advancement of an antibody into clinical trials. The antibody was developed using Medarex's UltiMAb technology and is the fourth UltiMAb-derived antibody in clinical development by Amgen. Medarex may receive future milestone payments and royalties should this product candidate progress through clinical development and to the market.
"We are pleased with the development progress that Amgen continues to make with our fully human antibody technology," said Irwin Lerner, chairman of the board of directors and interim president and chief executive officer of Medarex. "We believe that Amgen's proven product development experience has been key to their advancing the four UltiMAb antibodies into clinical trials."
Posted on November 13, 2006 @ 07:14 am
Cangene Corp.’s Varicella zoster immune globulin (VariZIG) has received orphan drug designation from the FDA for passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella. This designation would give the drug seven years of market exclusivity if marketing approval is obtained and certain regulatory filing fees will be waived.
"This designation is another step in our commitment to address the unmet medical need faced by susceptible individuals who are exposed to chickenpox. It builds on the expanded access investigational new drug protocol that was approved in January by the FDA," said Dr. John Langstaff, Cangene's president and chief executive officer.
Posted on November 10, 2006 @ 09:51 am
Bayer HealthCare is realigning the structure of its global pharmaceutical R&D organization and the company has outlined its future U.S. pharma site plan. Also, NJ will become the U.S. headquarters for pharmaceuticals. The restructuring follows Bayer's acquisition of Schering AG, Germany in June 2006 and serves as part of the company's plan to integrate its operations with Schering AG and Berlex, Inc. (the U.S. subsidiary of Schering AG).
Through the realignment, research programs and activities in various sites will be consolidated into three major R&D sites: Berlin and Wuppertal, Germany and Berkeley, CA. The Berlin research group will take leadership for diagnostic imaging, oncology and gynecology/andrology research and Wuppertal will be core for the company's cardiology research. Both locations have capabilities and activities in target discovery, lead generation and optimization, drug metabolism and pharmacokinetics, toxicology and clinical pharmacology.
As a result of this global consolidation, research operations at U.S. sites in West Haven, CT and Richmond, CA will close. The company will relocate remaining departments and functions currently based in West Haven into headquarters located in NJ.
Wayne and Montville, NJ will be headquarters for the company's U.S. pharmaceutical commercial operations and global oncology and specialized therapeutics business units, and U.S.-based global drug development groups and other business support functions. Employee groups transferring from other U.S. sites will move during the next 12-18 months.
Bayer anticipates that approximately 600 U.S. positions will be eliminated by these changes, primarily in research, and anticipates an additional 200 U.S.-based positions will be eliminated by the overall reorganization. After one-time costs of approximately $350 million, the company expects to reduce overall R&D costs by more than $210 million per year by the end of 2008. Employees whose positions are eliminated will receive severance packages and the company will provide a comprehensive support package to displaced employees to ensure a smooth transition. The company will also work with state and local governments as well as economic development authorities in the communities where locations are closing, in an attempt to minimize the impact to those communities.
"The changes in R&D will leverage the combined assets of Schering and Bayer to maximize both the output and effectiveness of our global drug discovery and development programs. They also give us the flexibility to substantially lower our ongoing infrastructure costs," said Arthur Higgins, chairman of Bayer HealthCare AG and chairman of Bayer Schering Pharma AG. The company anticipates the consolidation of research activities to be largely complete by the end of the first half of 2007.
Gunnar Riemann, member of the board of Bayer Schering Pharma AG in charge of the Latin and North American regions, said, "These changes will unlock opportunity for new drive and focus in the U.S. We can now bring together a critical mass of functions into a cohesive U.S. headquarters unit that blends the best of Bayer and Berlex talent and know-how. Ultimately, our goal is to create a high-performance U.S. organization that is lean, market-focused and capable of driving superior growth in one of the largest and most important pharmaceutical markets in the world."
Posted on November 10, 2006 @ 09:44 am
Following a review of strategic options for its global pharmaceuticals business,
3M Co. has agreed to sell its branded drug business for approximately $2.1 billion in a three-part transaction.
Graceway Pharmaceuticals, Inc. of Bristol, TN, will purchase 3M's pharmaceutical operations in the U.S., Canada and Latin America for $875 million, while
Meda AB, a Swedish drug manufacturer, will purchase its European pharmaceutical unit for $857 million. An investment group led by
Ironbridge Capital and
Archer Capital has agreed to acquire 3M's drug operations in the Asia Pacific region, Australia and South Africa for $349 million. The businesses include the skin cancer treatment Aldara as well as the drugs Minitran, Difflam, Duromine and Tambocor.
"These are great brands and products, and we believe they will thrive in today's very competitive pharmaceutical marketplace under the direction of their new owners," said Brad Sauer, executive vice president of 3M Health Care.
3M announced in April that it would try to sell the pharmaceutical unit, believing it would be worth more to a dedicated pharmaceutical company with the sales force to make it grow. At that time pharmaceuticals were about 20% of its health care division.
The pharmaceutical division employs about 1,050 people worldwide. 3M estimated that approximately 70% of those employees will have the opportunity to stay with the acquiring companies.
In a company statement, Sweden's Meda said the acquisition of 3M's European unit will strengthen its product portfolio and add about $280 million in annual sales, pushing it toward a goal of becoming the leading specialty pharmaceutical company in Europe. The sale is expected to close in the fourth quarter.
Posted on November 10, 2006 @ 09:43 am
Genentech, Inc. has plans to acquire
Tanox, Inc., a biotechnology company, for a total cash value of approximately $919 million. Tanox specializes in the discovery and development of biotherapeutics based on monoclonal antibody technology. The two companies have been working together in collaboration with Novartis since 1996 to develop and commercialize Xolair, an anti-IgE monoclonal antibody approved by the FDA in 2003 as a treatment for patients with moderate-to-severe allergic asthma.
Upon the closing of the acquisition, Genentech will improve its financial results for Xolair by eliminating the royalty it currently pays to Tanox and by obtaining Novartis' profit share and royalty payments to Tanox. Genentech will also acquire Tanox's product pipeline.
"IgE inhibition is an important way to treat patients with moderate-to-severe asthma and we look forward to growing our asthma business by increasing the number of patients treated and by introducing new indications, formulations, and next generation products. This acquisition will help us improve our profitability from Xolair," said Arthur Levinson, Ph.D., chief executive officer of Genentech. "We are also excited by molecules in the Tanox pipeline being developed to potentially treat diseases including asthma, HIV, and age-related macular degeneration," Mr. Levinson added.
"Joining with one of the world's leading biotech companies allows us to fully realize the potential of our drug development programs and the strong scientific platform developed by our researchers," said Tanox co-founder and chairman Nancy Chang, Ph.D. "We believe Genentech's offer reflects the value we have created and achieves a significant return for our shareholders."
Genentech and Tanox will be reviewing current operations and possible opportunities at Genentech for Tanox's employees in the coming months. The terms of the agreement have been approved by the boards of directors of both companies. The acquisition is subject to approval of Tanox's shareholders and customary closing conditions, including clearance under the Hart-Scott-Rodino Act. The transaction is expected to be complete by the end of the first quarter of 2007.
Posted on November 9, 2006 @ 09:35 am
The Tufts Center for the Study of Drug Development estimates the average cost of developing a new biotechnology product to be $1.2 billion, which reflects the costs of drugs that fail in testing and the time costs associated with bringing a new biopharmaceutical to market. Of this amount, out-of-pocket preclinical cost totaled $615 million, while similar clinical period cost totaled $626 million.
According to the Tufts CSDD analysis, clinical development and regulatory review for a new biopharmaceutical product took 97.7 months on average, about 8% longer than for pharmaceuticals.
“While biotech offers significant promise in treating entire categories of diseases for which no medicines previously existed, it comes at a significant cost,” said Tufts CSDD director of economic analysis, Joseph A. DiMasi.
Tufts CSDD estimates are based on compound-specific costs for a sample of 17 investigational biopharmaceuticals from four firms that first entered clinical testing from 1990 to 2003. Average development times and phase transition probabilities were estimated based on data from more than 500 therapeutic recombinant proteins and mAbs. The full R&D cost estimate was based on a clinical approval success rate (defined as obtaining U.S. regulatory approval for marketing) of 30.2% for biopharmaceuticals.
Additional study findings put the cost per approved biopharmaceutical for the preclinical period at $198 million. When capitalized, this estimate is $615 million per biopharmaceutical. Average clinical period cost per approved biopharmaceutical was $361 million. When capitalized, this estimate is $626 million. Capitalization increases biopharmaceutical costs relative to traditional pharma costs due to longer development timelines and a higher cost of capital. Also, biopharmaceuticals had an overall clinical approval success rate of 30.2% vs. 21.5% for traditional pharma firm pipelines.
Posted on November 9, 2006 @ 09:33 am
R. Ian Lennox has been appointed executive chairman at
Ricerca Biosciences, LLC. Mr. Lennox is co-founder of Impax/Fairway Capital, which manages more than $500 million of investment assets including CMDF Life Sciences funds. He was formerly chief executive officer of pharmaceutical and biotechnology markets at MDS, chief executive officer at Phoenix International Life Sciences, and executive chairman and chief executive officer at Drug Royalty Corp. Mr. Lennox's career began at Monsanto Co. where for almost 20 years he held various leadership positions in both U.S. and international operations.
"We are delighted to welcome Ian Lennox to Ricerca. He brings global life sciences experience and a track record of accomplishment in our industry," stated Tom Bradshaw, chief executive officer, Ricerca Biosciences. "Ian has already commenced work with the board and is focused on attracting additional scientific and management talents as well as resources required to implement Ricerca's new business plan," commented board member Sengal Selassie, Cowen Investment Holdings, LLC.
Posted on November 9, 2006 @ 09:29 am
AMRI has implemented a plan to restructure its large scale manufacturing operations in Rensselaer, NY, following a detailed analysis of the site's processes, management, cost structure, efficiency and profitability. The restructuring plan aims to strengthen the company's competitiveness in large scale manufacturing and reduce operating costs through leadership, increasing efficiency and eliminating overlap. Through this effort, the company expects annual savings of approximately $5 million beginning in 2007. The savings are expected to occur through workforce reductions as well as non-workforce-related actions such as disposal of underutilized assets, elimination of non-essential operating expenses, and reductions in raw material costs. Many of these initiatives will be implemented by the end of this year.
As part of this restructuring plan, the company expects to reduce the employee base at its Rensselaer manufacturing site by approximately 40 people, or 15% of the large scale manufacturing workforce, through attrition, retirements and job eliminations. Charges relating to this restructuring are estimated to be approximately $3 to $4 million.
Also, Kenton L. Shultis, vice president and general manager of the company's large scale manufacturing business, has been reassigned to an advisory role reporting to the chief executive officer, Thomas E. D'Ambra, Ph.D. The company is looking for a successor to Mr. Shultis.
"This initiative is designed to sharpen operational and financial focus on the size of our large scale manufacturing operations with customer demand, consistent with our business strategy," said Dr. D'Ambra. "We take these carefully considered steps as we continue to implement a well-defined growth strategy for our chemistry services business and, in particular, our large scale manufacturing operations. These actions build on our ongoing cost-savings efforts in Rensselaer, and support the transition of this facility away from a structure built to accommodate a few, larger legacy products to a more nimble, agile infrastructure that supports a number of projects produced simultaneously. As part of our efforts to focus resources at this facility, AMRI has invested over $40 million in improvements during the last three years. We take these actions today to position this key business component for both near- and long-term growth, and help establish the Rensselaer facility as a key driver for revenue and earnings well into the future."
Posted on November 9, 2006 @ 09:18 am
AMRI
3Q Revenues: $44.2 million (flat)
3Q Earnings: $1.4 million (-68%)
YTD Revenues: $133.2 million (-8%)
YTD Earnings: $2.9 million (-83%)
Comments: Total contract revenue for the quarter was $37.9 million, up 20%. Contract revenue for discovery services was $10.0 million, up 61%. Contract revenue from development and small scale manufacturing in the quarter was $9.6 million, up 45%. Large scale manufacturing revenues were $18.2 million, down 2%. Results for the quarter and YTD reflect a reduction in Allegra royalties, as well as the effects on large scale manufacturing due to the discontinuation of one product supplied to GE Healthcare in 2005.
Posted on November 8, 2006 @ 09:20 am
Genentech, Inc. has entered into an agreement with
Lonza Group, Ltd. for the sale of Genentech's manufacturing facility in Porrino, Spain for $150 million. The company has also entered into a supply agreement for the manufacture of certain products at Lonza's facility that is currently under construction in Singapore. Genentech will also have the right to exercise an exclusive option to purchase the Singapore facility.
Under the terms of the agreement, Lonza will acquire Genentech's FDA-licensed Porrino facility, which has 40,000 liters of biologic manufacturing capacity and is currently dedicated to the production of Genentech's Avastin. Lonza plans to retain the facility's 310 employees and will continue to produce Avastin for Genentech under the terms of a supply agreement.
Genentech plans to purchase Avastin and other oncology products from Lonza's planned 80,000-liter Singapore facility. FDA licensure for producing Avastin at Lonza's Singapore plant is expected in 2010. The terms of the option to purchase the facility allow Genentech to acquire the facility during the period from 2007 to 2012 for $290 million, plus an additional $70 million in milestone payments if certain performance milestones are met.
"We believe that this transaction provides Genentech with benefits that enhance our manufacturing organization and strengthen our strategic relationship with Lonza," said Patrick Y. Yang, Ph.D., executive vice president of Genentech's Product Operations. "We are pleased that the FDA-licensed Porrino facility and its highly-skilled employees will continue to supply product to our patients with new Lonza ownership, and we expect that our agreements, including an option to acquire Lonza's 80,000-liter facility in Singapore, will provide Genentech with flexibility, capacity and cost effectiveness to significantly improve our manufacturing capability."
The transaction is subject to various closing conditions. The companies anticipate closing the transaction before the end of 2006.
Posted on November 8, 2006 @ 09:18 am
Biovitrum has entered an agreement with
Resistentia Pharmaceuticals for process development and manufacturing of the biopharmaceutical substance RES 08 intended for use in Phase III trials of Resistentia's new protein-based drug candidate for the treatment of allergy.
RES 08 works by blocking the effect of IgE, preventing an allergic reaction and is intended for the treatment of IgE-mediated allergies. Biovitrum's assignment is to develop the existing process for the biotechnical manufacturing of RES 08 to a standard that meets the demands of a Phase III trial, and furthermore to manufacture sufficient amounts of the substance for the trial. The project will run for more than two years beginning in November 2006.
"We are very pleased with our partnership with the Swedish company Resistentia. This is a complex and extensive assignment which further emphasizes Biovitrum's role as a leading company in the Nordic biopharma industry," said Mats Pettersson, president of Biovitrum.
Marcus Bosson, president of Resistentia, said, "Biovitrum's experience and expertise in the development and manufacturing of Phase III processes is of vital importance at this stage to efficiently advance our project one step closer towards the market."
Posted on November 8, 2006 @ 09:15 am
Crucell N.V. and
DSM Biologics have opened the Percivia PER.C6 Development Center as part of a previously announced joint venture between the two companies. Percivia was designed to advance the PER.C6 cell line and provide solutions for the production of pharmaceutical proteins to licensees utilizing the PER.C6 human cell line in the biopharma industry.
"Percivia's state-of-the-art facility will support the use of PER.C6 cells in the manufacturing of human therapeutic proteins," said Dr. Marco Cacciuttolo, chief executive officer of Percivia. "With more than 20 companies licensing the technology for protein and monoclonal antibody production, we anticipate that the PER.C6 cell line will become the leading choice for many biotechnology and pharmaceutical companies, and Percivia is well-positioned to support this growing market."
"The tremendous promise and potential of PER.C6 technology has become apparent not only from our own work, but particularly from customer and licensee feedback," commented Leendert Staal, chief executive officer of DSM Pharmaceutical Products. "This R&D center dedicated to the further development of the PER.C6 technology platform will play a key role in establishing the PER.C6 cell line as a new standard in the production of human therapeutic proteins."
Ronald H.P. Brus, president and chief executive officer of Crucell, said, "Our current and future PER.C6 technology licensees will be able to continuously benefit from the know-how generated in the Percivia PER.C6 Development Center. The recombinant protein market is very large and still growing, and we believe that this center will provide an important service to licensees in this progressive industry."
Posted on November 7, 2006 @ 08:40 am
DPT Laboratories, Ltd., a DFB company, has opened its new, 258,000-sq.-ft. research, development, manufacturing, and distribution facilities, in San Antonio.
"We're thrilled to be part of the continuing emergence of San Antonio's biosciences economy," said DFB president and chief operating officer, John W. Feik. "And it's been great to have the opportunity to show off our new facilities and our great city to AAPS convention delegates from some of the biggest companies in the industry. We're proud of what everyone at DPT has accomplished so far but we're even more excited about the future and this campus."
The new facilities at Brooks City-Base enable the company to expand its formulation development and analytical chemistry capabilities while continuing to provide development solutions to clients. In addition to the new research center, functions of the new campus include front-end manufacturing processes, quality control labs, storage of raw materials and finished goods, and worldwide product distribution.
The $24 million project was developed for DPT under an 18-year build-to-suit lease agreement with the Brooks Development Authority, which owns the buildings and is leasing them back to the company. The two buildings encompass 224,000 sq. ft. and 34,000 sq. ft., respectively.
DPT will retain 136 pharma and biopharma jobs in San Antonio, with the plan to expand to 250 by 2010. Current staffing at Brooks includes skilled warehousing and laboratory staff and technicians as well as scientists representing multiple research disciplines.
Posted on November 7, 2006 @ 08:37 am
Cambridge Antibody Technology (CAT) is expanding its operations in Cambridge, UK, by leasing the building currently known as Unit GP15 on Granta Park, the science park near Cambridge where the company has two facilities.
Unit GP15, which was previously occupied by Millennium Pharmaceuticals and was vacated in 2003, will provide CAT with an additional 92,000 sq. ft. of state-of-the-art laboratory and associated open-plan office space. The company plans to alter the internal layout of the building prior to occupation in the next 12 to 15 months.
Hamish Cameron, CAT's chief executive officer, commented, "This investment in CAT's future is essential for us to achieve our planned expansion as part of the AstraZeneca group of companies. CAT is on a journey to create an outstanding biopharmaceutical company and is central to AstraZeneca's plans to establish a major international presence in the R&D of biological therapeutics. Starting next year, CAT will be recruiting a significant number of new staff, across all functions and at all levels, to join our team and this additional space is being prepared to accommodate this growth. Unit GP15 is ideal for us, and when fully occupied will house between 250-300 people. It is a high quality building and, being so close to our existing facilities on Granta Park, it will allow many of our staff to continue to work easily and closely together, an important feature of CAT's working culture, and one which we will strive to maintain as we grow."
Posted on November 7, 2006 @ 08:34 am
PDI, Inc. has appointed
David N. Stievater to the newly created position of senior vice president, emerging pharma, reporting to Michael Marquard, chief executive officer. Mr. Stievater will also serve on the executive committee.
Mr. Stievater joins the company from ImpactRx where he served as vice president of sales and vice president of business development, and was a member of the executive team. Prior to ImpactRx, he spent several years providing consulting services including marketing decision support to the biopharmaceutical industry, and concluded an 11-year tenure with the Monitor Company Group as partner and global account manager. He has advised pharmaceutical clients on such issues as sales force strategy and multi-channel physician marketing. Mr. Stievater began his career as a financial analyst at Merrill Lynch & Co.
Michael Marquard, PDI's chief executive officer, stated, "We are delighted to have David join PDI as part of the management team. David is a highly credentialed executive who brings extensive business development expertise within the pharmaceutical industry, including emerging companies, which is an essential part of PDI's growth strategy."
Mr. Stievater stated, "This is a very exciting time to be joining PDI. As the pharmaceutical industry model continues to evolve, there is tremendous opportunity to better serve a wider range of companies with value added sales and marketing services. PDI's expanded focus on earlier stage biotech and pharmaceutical clients establishes a broader base for solid growth. I look forward to having a significant impact on that effort."
Posted on November 6, 2006 @ 09:19 am
Abbott has entered into a definitive agreement to acquire
Kos Pharmaceuticals in a transaction valued at $3.7 billion. Kos is a specialty pharmaceutical company that develops and markets proprietary medications for the treatment of chronic cardiovascular, metabolic and respiratory diseases. Kos is based in Cranbury, NJ.
"Kos Pharmaceuticals is an excellent strategic fit for Abbott, both scientifically and commercially," said Miles D. White, chairman and chief executive officer, Abbott. "This acquisition expands Abbott's presence in the lipid management market and will provide several on-market and late-stage pipeline products. Kos also complements our existing commercial and research and development expertise, and increases our R&D spending capacity."
"Since being founded in 1988 by our current chairman Emeritus Michael Jaharis and chairman Daniel Bell, Kos has pioneered the HDL therapy area in the U.S. and firmly established Niaspan and Advicor as successful and highly differentiated therapies," said Adrian Adams, president and chief executive officer, Kos Pharmaceuticals. "This is an opportune time to become a part of another fast-growing organization like Abbott with the shared experience and additional resources to help capture the full value of our highly differentiated cholesterol franchise and our growing R&D pipeline."
Posted on November 6, 2006 @ 09:14 am
Ambit Biosciences has entered a screening, discovery and development collaboration with
Cephalon, Inc. aimed at establishing best-in-class kinase inhibitors as candidates for clinical research. By combining Ambit's KinomeScan-driven discovery capabilities with Cephalon's chemistry, discovery and development capabilities, the two companies expect to discover and develop small molecule pharmaceutical products in significantly less time.
Kinases consist of more than 500 related enzymes that play an important role in a range of human ailments, including cancer, inflammation, diabetes, infection, cardiovascular disease and central nervous system disorders.
"While they are our fourth major collaborator, Cephalon is the first pharmaceutical company to take complete advantage of Ambit's proprietary discovery platform," said Scott Salka, chief executive officer of Ambit. "The cornerstone of the collaboration is Ambit's unequaled ability to screen chemical libraries across a panel of 300 kinases, which will be used to rapidly annotate Cephalon's focused library of potential kinase inhibitors."
"Our structurally diverse, proprietary chemical library of kinase inhibitors is among our most valuable assets. We see this collaboration as an opportunity to extract the maximum value from this asset in the shortest period of time," said Jeffrey Vaught, Ph.D., executive vice president, R&D at Cephalon. "Ambit's technology will allow us to identify the best compounds for further research and to continue improving those we select through ongoing and iterative screening integrated tightly with our own medicinal chemistry and pharmacology efforts."
Cephalon will pay an up-front fee of $18 million to Ambit for access to its KinomeScan technology. In addition, the companies will collaborate on advancing two programs targeting undisclosed kinases, with Ambit having primary responsibility for delivering clinical candidates that Cephalon will further develop in exchange for additional milestone payments to Ambit of as much as $232.5 million and royalties on commercial sales. Ambit will also have the opportunity to use Cephalon's library of compounds to discover and develop products that are effective inhibitors of certain undisclosed kinases.
Posted on November 6, 2006 @ 09:08 am
Ziopharm Oncology, Inc. has signed a definitive agreement to acquire indibulin, a novel synthetic anti-cancer agent that targets mitosis, from affiliates of
Baxter Healthcare Corp. Indibulin is available as both an oral and a nanosuspension intravenous (IV) form with the oral form in a Phase I trial and the nanosuspension in late preclinical. Indibulin, now designated as ZIO-301, may offer efficacy, dosing and toxicity advantages as compared to marketed taxanes, including paclitaxel (Taxol), paclitaxel protein-bound particles for injectable suspension (Abraxane), and docetaxel (Taxotere).
The Phase I trial is ongoing at the Netherlands Cancer Institute and University Medical Center, Utrecht. As part of the purchase, the company has acquired the existing drug supply manufactured by Baxter and has assumed all responsibility for the Phase I trial. The company expects to file an IND to initiate a Phase II study with the oral form in the first half of 2007 followed by Phase I trials with the IV formulation.
Taxanes are administered by IV and are among the most effective clinical chemotherapeutic agents with sales of more than $3 billion in 2005. However, all of the marketed agents are associated with severe toxicities. The company believes that indibulin has the potential to provide important advantages over currently marketed taxanes, including reduced toxicity, activity against multi-drug and taxane resistant tumors and the availability of both an oral and an IV nanosuspension.
Terms of the acquisition include an upfront cash payment, clinical and regulatory-based milestone payments, and royalties on net product sales.
Posted on November 3, 2006 @ 08:59 am
Oramed Pharmaceuticals, Inc. has signed a manufacturing agreement with
Swiss Caps AG for the manufacture of gel capsules for its Phase I trials. In lieu of a cash payment, Swiss Caps offered a straight equity exchange for its services and will be paid in shares. This followed a due diligence process and an in-depth review of Oramed's oral delivery technology, according to a Swiis Caps statement.
"This type of agreement means cooperation with Swiss Caps rather than just out-service of the production line. Swiss Caps brings to the table skills and knowledge that goes beyond the direct execution of our formula and we are looking forward to seeing the benefits from our group effort," stated Nadav Kidron, Oramed's chief executive officer.
This agreement is only for the manufacturing of the product for proof of efficacy in clinical trials. Should Swiss Caps manufacture Oramed's drug product for commercial purposes, the contract will be renegotiated.
Posted on November 3, 2006 @ 08:57 am
InterMune, Inc. has closed its exclusive license and collaboration agreement with
Roche for the exclusive worldwide development and commercialization of InterMune's hepatitis C virus (HCV) protease inhibitor program. The parties received notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, on October 30th.
As a result of the closing, InterMune will receive an upfront payment of $60 million. Roche is now funding 67% of the global development costs associated with ITMN-191, InterMune's lead HCV protease inhibitor drug candidate. If the development and commercialization of ITMN-191 is successful, InterMune could receive as much as $470 million in milestones, including a potential $35 million within the next 12 months.
Posted on November 3, 2006 @ 08:56 am
DPT Laboratories, Ltd., a DFB Company, has named
Lyle Flom senior director of site operations for San Antonio. In his new role, Mr. Flom will be the site leader directly managing all manufacturing activities while indirectly managing all of the departments that support the manufacture of products in the San Antonio facility. He will report to vice president of operations
Mark Fite. Mr. Flom joined the company in 2001 as a finance manager and was promoted to director of finance/plant controller in 2003.
"Possessing a strong process and profit improvement mindset, Lyle has demonstrated success driving improvement and profitability at the San Antonio site," Mr. Fite said.
Posted on November 3, 2006 @ 08:53 am
DSM Biologics and
UMN Pharma, Inc. have signed a biopharmaceutical manufacturing agreement based on the PER.C6 platform. Under the terms of the agreement DSM Biologics will provide UMN Pharma with full process and analytical development services and cGMP manufacturing batches for UMN’s fusion protein, UMN-03, for the treatment of muscular dystrophy and metabolic diseases. The services will be provided out of DSM Biologics’ FDA-approved manufacturing facility in Groningen. The agreement follows the license agreement that was signed in March of this year between UMN Pharma, DSM Biologics and Crucell.
"The agreement builds further on the PER.C6 license agreement that is in place between UMN Pharma, DSM Biologics and Crucell. We gladly entrust DSM Biologics with the execution of this manufacturing agreement that is crucial for the success of our UMN-03 fusion protein," said Yasunari Kashihara, president and chief executive officer of UMN Pharma.
"DSM Biologics is very happy to be involved in this exciting project. The agreement is a further example of the broad use of the PER.C6 manufacturing platform. It is also a clear recognition of the value that DSM Biologics and the PER.C6 manufacturing platform are expected to bring to UMN Pharma, an important client for DSM Biologics," said Terry Novak, business director and chief marketing officer for DSM Biologics.
Posted on November 2, 2006 @ 10:07 am
Akorn, Inc. has added two injectable drug products to its API supply and margin sharing agreement with
Natco Pharma. The two ANDA drug products are indicated for the prevention of nausea and vomiting associated with cancer chemotherapy.
Under the agreement, signed April 2006, Natco will be responsible for the supply of API for both drug products and Akorn will be responsible for the manufacturing, regulatory submissions, marketing and distribution in the hospital, clinic, and home healthcare markets in the U.S. and Canada.
Arthur S. Przybyl, Akorn's president and chief executive officer, stated, "We are excited to expand our business partnership with Natco Pharma. These two products will provide an excellent fit with our oncology product pipeline."
Rejeev Nannapaneni, Natco Pharma's chief operating officer, stated, "We are happy to take our cooperation to four projects now. This deal structure will enhance business opportunities in an increasingly competitive environment."
Posted on November 2, 2006 @ 10:06 am
Schering-Plough has expanded discovery operations in Cambridge, MA with a new research facility to support the discovery and development of new therapeutic treatments. The state-of-the-art lab will accommodate approximately 200 scientists and support staff, more than twice that of the prior Cambridge location, and it provides more than triple the amount of lab space.
"This new facility is another demonstration of our long-term commitment to research-based health innovation. It also is evidence of our growing engagement in the science community of Cambridge, which with neighboring Boston has become one of the world's premier research hubs for life science discoveries," said Fred Hassan, Schering-Plough chairman and chief executive officer. "This kind of investment in discovery research is an engine of innovation at Schering-Plough for improved health for patients for the future."
Schering-Plough Research Institute (SPRI) Cambridge focuses on the early stages of the drug discovery process, conducting research to develop a portfolio of small molecule drugs and provide efficiency in lead discovery through the use of proprietary affinity-based screening technologies and an integrated chemistry library.
"The greater Boston area is a vibrant and stimulating scientific environment. Our SPRI scientists benefit from the proximity of major academic institutions and leading biotechnology companies based nearby," said Thomas D. Koestler, Ph.D., executive vice president, Schering-Plough and president, SPRI. "SPRI Cambridge, along with our research facilities in NJ and CA, is part of an integrated drug discovery organization that is developing an important pipeline of potential new medicines."
Posted on November 2, 2006 @ 10:00 am
Enzon
3Q Revenues: $45.9 million (+4%)
3Q Earnings: $2.2 million (loss of $5.8 million 3Q2005)*
Comments: Sales from the products segment were flat at $25.3 million. Sales of Oncaspar were up 28% to $7.4 million and sales of Adagen were up 16% to $6.9 million. Sales of Abelcet in the U.S. and Canada were $9 million, down 19% and sales of Depocytwere down 14% to $2 million. Contract manufacturing revenues were $1.9 million for the quarter as compared to $3.4 million 3Q2005. R&D expenses were $10.6 million in the quarter, as compared to $5.3 million 3Q2005. The increase was attributable to initiation of programs in 2006.
*Amortization expense decreased by $3.1 million to $184 thousand in the quarter. The decrease is related to Abelcet intangible assets.
Posted on November 1, 2006 @ 03:40 am
Sanofi-Aventis 3Q
3Q Revenues: $8.8 billion (-1%)
3Q Earnings: $1.5 billion
YTD Revenues: $26.7 billion (+3%)
YTD Earnings: $4.4 billion (+100%)
Comments: 3Q net sales for the pharmaceuticals business were hit hard by the introduction of generic versions of four products in the U.S. and the effect of healthcare system reforms in France and Germany, falling by 0.4% to $8.0 billion. Net sales of the top 15 products advanced by 1.5% to $5.4 billion, representing 67.5% of pharmaceuticals net sales, against 66.2% for the comparable period in 2005.
Posted on November 1, 2006 @ 03:37 am
Excel Life Sciences, a U.S.-based, India-focused company, has hired Dr. Vijai Kumar to serve as the company's president and chief medical officer. Dr. Kumar has been involved with more than 200 clinical trials and 20 approved NDAs in the U.S., Europe and Asia.
"Dr. Kumar's leadership, combined with the unique assets of Excel Life Sciences, will create an unmatched presence in this industry. It will help biopharmaceutical companies conduct global clinical trials in India with confidence, while complying with the highest regulatory and ethical requirements," said Bedi Singh, Excel Life Sciences Chairman and former CFO of Novartis Pharmaceuticals. "His extensive experience in almost all aspects of drug development and research methodology will help us consistently exceed our customer expectations."
Dr. Kumar previously served as the global medical director of Neeman Medical. In addition, he has been active in a variety of expert groups convened by the Drugs Controller General (India) to develop GCP guidelines and review the existing Drugs and Cosmetics Act.
Excel Life Sciences' service offerings include clinical trials, technology transfer, product licensing, formulation research, new product development, establishing GCP compliant sites and training of all clinical trials stakeholders, with an emphasis on emerging markets.
October 2006
Posted on October 31, 2006 @ 08:12 pm
VWR International, Inc. has established VWR Lab Products Private Limited, a full-service, wholly owned subsidiary in Bangalore, India to better serve the needs of the rapidly expanding pharmaceutical and biotech industry in the subcontinent.
The new office serves as a central resource for customer service, sales support and technical services for the Indian subcontinent. As a fully licensed Indian company, the new office has the ability to hire locally and conduct transactions in local currency, offering an added convenience for VWR's global customers. The office will also continue to serve as a location for VWR's strategic sourcing of laboratory supplies, equipment and instruments within India.
"India has been a significant player in the global science and research arena for some time now. India's abundant highly educated, competitive, English-speaking workforce continues to attract international companies. Several of VWR's current global customers, have opened their research and manufacturing facilities in India," said Ted Pulkownik, senior vice president of Strategy, Corporate Development and Emerging Markets, VWR. "Coupled with the rapidly expanding domestic pharmaceutical and biotech industry in the Indian subcontinent, this presents a tremendous opportunity for VWR to meet the needs of our existing customers and to tap into new market growth, while supporting VWR's overall strategy of geographic expansion with first-class local service for our customers."
"India is a growth market for VWR and has traditionally lacked a one-stop-shop provider for laboratory products with the capability to offer everything from consumables to instruments. VWR will now fill that void and help create procurement efficiencies along with global product standardization in terms of range and quality," said M.K. Sathya, vice president of Corporate Initiatives, VWR. "The needs of our customers will be better served with a local office that can provide immediate solutions for their business challenges."
Posted on October 31, 2006 @ 07:04 am
Akorn Inc. Third Quarter Report
3Q Revenues: $14.5 million (+32%)
3Q Loss: $1.2 million (loss of $3.6 million in 3Q2005)
YTD Revenues: $56.7 million (+68%)
YTD Loss: $0.6 million (loss of $8.0 million in YTD2005)
Comments: Two new contract manufacturing supply agreements were signed, one with GeneraMedix and one with Advanced Vision Research.The two agreements are projected to increase Contract Manufacturing sales by approximately 50% on an annualized basis, beginning in 2007. They are expected to contribute revenue in the fourth quarter of 2006.
Posted on October 31, 2006 @ 07:02 am
Charles River Laboratories International (CRL) has acquired privately held Tacoma, WA-based
Northwest Kinetics for $29.5 million dollars. The acquisition establishes a Phase I clinical services capacity for CRL in North America, which in conjunction with its Phase I facility in Edinburgh, Scotland, positions the company to support its clients' clinical pharmacology studies and further expands CRL's role in preclinical and early clinical development.
Northwest Kinetics is a 150-bed facility with expertise in branded-drug studies. It is currently in the process of expanding to 250 beds, which provides a platform for continued growth. When the expansion is completed in the fourth quarter of 2006, CRL will have a global capacity of more than 300 beds.
James C. Foster, chairman, president and chief executive officer of CRL, said, "Our mission is to support our clients' drug development needs from discovery to preclinical development to Phase I clinical trials, and the acquisition of Northwest Kinetics meets a key objective in strengthening our Phase I service offerings. With this acquisition, we can now offer high-end clinical pharmacology services in North America, complementing our presence in Scotland. Through its management's deep scientific and medical backgrounds, Northwest Kinetics has established itself as a premier provider of branded drug studies, and we expect to leverage that expertise on a global basis as we expand our Phase I service offerings. Northwest Kinetics' scientific excellence and outstanding customer service make it a superb fit for us, as these are the hallmarks of Charles River. We are very pleased to welcome Northwest Kinetics to the Charles River family."
Posted on October 31, 2006 @ 06:59 am
Merck has agreed to acquire
Sirna Therapeutics for approximately $1.1 billion. Sirna has been at the forefront of efforts to create RNAi-based therapeutics, medicines which selectively catalyze the destruction of the RNA transcribed from an individual gene. This enables an entirely novel approach to discovering drugs with the potential to produce highly specific, potent, and long-lasting effects. The two companies expect to complete the acquisition in the first quarter of 2007.
The acquisition of Sirna is seen as a component of Merck's RNA expression research that began with the 2001 acquisition of Rosetta Inpharmatics. "We are delighted about our agreement to acquire Sirna Therapeutics, a company that has established a leading presence in the critically important area of RNAi," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We believe that RNAi could significantly change the way in which we go about discovering and developing drugs, and could become a new way to treat patients with unmet medical needs."
"RNAi is a powerful enabler of drug discovery in cells, in animals, and in humans. We can potentially use this technology to target the activity of genes which control the activity of cancer cells, and so produce their destruction without damaging normal cells," said Stephen H. Friend, M.D., Ph.D., executive vice president and franchise head, Oncology and Neuroscience, Merck Research Laboratories.
Sirna's lead clinical development candidate, Sirna-027, is a chemically optimized, short interfering RNA (siRNA) currently moving into Phase II development for the treatment of the wet-form of age related macular degeneration (AMD) as part of a broad collaboration with Allergan, Inc. in the area of ophthalmic diseases. In addition to the collaboration with Allergan, Sirna has established a strategic alliance with GlaxoSmithKline for the development of siRNA compounds for the treatment of respiratory diseases. Besides its external collaborations, Sirna has several programs covering a broad range of therapeutic areas, including infectious diseases, metabolism, CNS and dermatology.
"We are excited about the opportunity to undertake the discovery and development of therapeutic siRNAs with Merck, a company that clearly recognizes the potential of this breakthrough technology," said Sirna Senior Vice President of Research and Chief Scientific Officer Barry Polisky. "Merck's commitment to the development of RNAi-based therapeutics will ensure that this novel therapeutic modality will achieve its full potential."
Richard N. Kender, vice president of Business Development and Corporate Licensing at Merck, noted that Merck's acquisition of Sirna "is another example of Merck delivering on its strategy of aggressively pursuing biotechnology companies that complement our considerable internal research capabilities."
Posted on October 30, 2006 @ 09:40 am
Albany Molecular Research, Inc. (AMRI) has selected a compound from its proprietary oncology research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) to the FDA in 2007.
AMRI's drug candidate is a novel analog of an established class of tubulin inhibitors, which kill cancer cells by preventing cell mitosis. In preclinical disease models, AMRI's compound showed greater efficacy than marketed members of this class. Significant tumor growth delay was seen against human colon, lung and prostate solid tumors (as xenografts in mice) and against leukemia in mice. Pending favorable results in toxicity and safety pharmacology testing, the company plans to submit an IND for this compound in late 2007. Subject to FDA review, the submission of an IND would allow subsequent initiation of Phase I human clinical trials.
"This new drug candidate from our internal oncology research program continues to demonstrate AMRI's ability to deliver compounds with promising pharmaceutical utility from our labs, whether the compound is for one of the customers we serve or from our own internal R&D efforts," said AMRI's chairman, chief executive officer and president, Thomas E. D'Ambra, Ph.D. "This particular research program leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities."
This marks the second time in two years that AMRI has transitioned early stage, internal drug leads into clinical candidates. In May 2005, AMRI selected two compounds from its proprietary biogenic amines program for advanced preclinical testing. This program was subsequently the subject of a licensing arrangement with Bristol-Myers Squibb, announced in October 2005.
AMRI's latest compound is a cytotoxic agent and a semi-synthetic derivative of a natural product originally extracted from the Madagascar periwinkle flower.
Posted on October 30, 2006 @ 09:36 am
Emisphere Technologies has produced results from its 90-day, Phase II study of oral insulin product utilizing its eligen oral delivery technology. The four-arm study evaluated the safety and efficacy of low and high fixed doses of oral insulin tablets versus placebo in patients with Type 2 Diabetes Mellitus on existing oral metformin monotherapy. The trial focused on the safety of oral insulin, specifically noting incidents of hypoglycemia, as well as the occurrence of insulin antibodies. The efficacy component of the trial was designed to measure changes in Hemoglobin A1c (HbA1c) over 90 days, the standard for evaluating glucose control in Type II diabetics. An additional objective was to confirm that insulin delivered orally could be administered as a fixed dose product without the need to conduct glucose monitoring or titrate the insulin dose. The study met the company's objectives for both safety and efficacy.
Emisphere believes its oral insulin product has a very encouraging safety profile. During the study, there were no significant differences in number of hypoglycemic events, serious adverse events, or insulin antibody formation for the orally administered insulin compared to placebo. There were no hypoglycemic events in any of the high responder patients as measured by HbA1c. There were no insulin antibodies in any of the three oral insulin arms. The patients in all three active arms saw no change in weight and no nighttime hypoglycemic events.
"We are very pleased with these study results. The goal of this study was to demonstrate that orally dosed insulin can be effective and safe in a real world setting over a protracted period of time, 90 days, without the need to titrate the dose or frequently monitor the blood glucose levels. Such a product can improve both the quality of care and the quality of life for many diabetics" said Michael M. Goldberg, M.D., chairman and chief executive officer of Emisphere. "The oral delivery of insulin has been an important goal of the pharmaceutical industry since insulin's discovery over 80 years ago. The results from this Phase II study represent a major milestone in Emisphere's efforts toward the accomplishment of that goal. The Phase 2 clinical trial was also designed to evaluate the safety and efficacy of various dosage strengths of our product compared to placebo. In- depth analysis of the data from this study should better define the patient populations most likely to benefit from the unique characteristics of oral insulin."
Posted on October 27, 2006 @ 09:30 am
Qualia Clinical Services and
Tandem Labs have entered a strategic alliance in an effort to create a value proposition for the pharma, biopharma and generic industries by providing access to streamlined drug development services with an emphasis on quality and efficiency.
The two companies will offer clients access to the complete suite of services related to clinical research. Through the alliance, clients can expect synchronized scheduling to minimize “downtime” between clinical completion and sample transfer for bioanalysis, utilize the companies as one resource, and maintain a single point of contact throughout all aspects of the project, according to the companies.
“The need for accurate data delivered in a timely fashion is critical to our clients. Through our alliance with Tandem Labs, Qualia now has access to one of the leading bioanalytical laboratories. Their core values are aligned with ours—both companies are client focused and have a passion for quality. The foundation of combined industry experience is quite impressive,” said Sohail Khattak, M.D., FRCP(C), president and chief executive officer, Qualia.
“This alliance gives us the unique opportunity to partner with another CRO that provides exceptional customer care combined with scientific expertise,” said Denis Lin, Ph.D., president and chief executive officer, Tandem Labs. “It is a true partnership: Qualia’s strong clinical research foundation combined with Tandem’s scientific knowledge, low-risk approach, and technologies.”
Posted on October 26, 2006 @ 10:44 am
Aptuit has signed an agreement to acquire
SSCI, Inc. The acquisition will enable Aptuit to leverage SSCI’s expertise in solid-state pharmaceutical product development to broaden its service offering for customers. As part of the agreement, Aptuit will acquire SSCI’s facilities in West Lafayette, IN, Atlanta, GA, Oxford, UK, and retain SSCI’s 100 employees. SSCI will continue to operate under the SSCI brand for a period of time, to allow for a seamless transition between the two companies' service offerings. The acquisition is expected to close within 30 days. Financial terms of the agreement were not disclosed.
“SSCI is the clear leader in the field of analytical services and solid-state chemistry and crystallization,” stated Michael A. Griffith, chief executive officer of Aptuit. “By integrating their service offering with our existing analytic and API development capabilities, we can offer customers a more robust and seamless offering to move product candidates toward the clinic and the marketplace. SSCI’s strength in polymorph, salt, cocrystal, amorphous material, and analytical research have helped customers improve development outcomes and build sound intellectual property positions along the way.”
SSCI’s chief executive officer, Sally Byrn, who was named vice president, physical and analytical chemistry at Aptuit, stated, “Together SSCI and Aptuit are in a great position to reengineer the drug development process, bringing our customers unprecedented speed to market while helping to achieve the FDA mandate of Quality by Design.”
Also, several members of the SSCI management team have been named to leadership positions within Aptuit: Richard Ferguson, SSCI's chief financial officer has been named vice president, treasurer; David Bertolino will become senior director, human resources; and Daniel Pannell will become senior director, physical and analytical chemistry.
With the acquisition, Aptuit will now be able to offer customers: control of the solid form throughout the development process; state-of-the-art analytical services, particularly solids; and SSCI’s cGMP analytical services. SSCI and Aptuit are also adding analytical services for protein and peptide drugs. These services include: conventional analyses as well as X-ray powder diffraction, dynamic light scattering, characterization, stability, and formulation studies.
Posted on October 26, 2006 @ 10:42 am
Laureate Pharma, Inc. has renewed its agreement with
Cytogen Corp. for the cGMP manufacture of ProstaScint, Cytogen's proprietary monoclonal antibody immunoconjugate that is used for imaging in patients diagnosed with prostate cancer. Under the agreement, Laureate will provide cGMP protein production, purification, conjugation of Cytogen's proprietary linker chelator and aseptic filling services to support commercial ProstaScint requirements. Terms of the agreement were not disclosed.
"We are delighted by the confidence that Cytogen has shown in Laureate by continuing to utilize our specialized experience in the manufacture of ProstaScint," said Robert J. Broeze, president and chief executive officer of Laureate. "We have developed a great working relationship with our colleagues at Cytogen and we look forward to helping them achieve their manufacturing objectives."
Laureate has been manufacturing ProstaScint at its cGMP manufacturing facility in Princeton, NJ for more than 10 years.
Posted on October 26, 2006 @ 10:40 am
Integrated Project Services (IPS):
Saul A. Edenbaum has been named manager, process engineering to its growing process technology group. As a key manager, Mr. Edenbaum will provide his extensive industry insight and leadership to IPS's PA-based process and technology engineering specialists.
"Saul's track record of process and project engineering and his extensive experience in working with biopharmaceutical and life sciences companies is noteworthy and we are looking forward to his contributions to our management team," said David Goswami, P.E., principal and president. "His skills in developing new processes and technology management are a great asset and we are very pleased that Saul has joined IPS."
Mr. Edenbaum has more than 25 years of biopharmaceutical and life sciences experience. He joins the company from Washington Group International and its legacy companies, all providers of integrated engineering, construction, and management solutions, where he held numerous management positions with increasing responsibilities. Most recently, Mr. Edenbaum was director of engineering and technology, biopharmaceutical division and was responsible for identifying new technologies in the areas of bulk API pharmaceuticals, biotechnology and secondary manufacturing. He began his career with Tenneco Chemicals, and E.I. DuPont De Nemours as a process/project engineer.
Also,
Gabriel J. Lopez, P.E. has been appointed engineering manager, PR. Mr. Lopez will oversee and coordinate the activities of the architectural and engineering design departments for IPS's PR-based projects. He will provide mechanical engineering design expertise to ensure quality and compliance for pharma and biopharma companies with key manufacturing operations on the island.
"Gabriel joins a highly-talented team of licensed engineers and architects at IPS PR, and we expect that his focused leadership will assist biotech and pharmaceutical companies improve operations, revitalize facilities, and stay compliant in today's challenging regulatory environment," said Sterling G. Kline, R.A., senior director, project development. "His considerable knowledge of the industry, particularly relating to bulk and finished product pharmaceutical manufacturing facilities, coupled with his first-hand mechanical engineering experience, and customer focus, will be a great asset to IPS and our clients."
Mr. Lopez has more than 18 years of experience providing mechanical engineering design services for the manufacturing and pharmaceutical industries. His areas of expertise include HVAC design for class 100 sterile facilities and OSD manufacturing suites handling both potent and non-potent products. The type of projects includes sterile and oral solid dosage facilities, API chemical plants, laboratories, medical devices, healthcare, and microelectronics. Prior to joining the company, Mr. Lopez served as HVAC department manager for several firms dedicated to serving pharma and biopharma companies.
Posted on October 26, 2006 @ 10:36 am
BMS
3Q Revenues: $4.2 billion (-13%)
3Q Earnings: $338 million (-65%)
YTD revenues: $13.7 billion (-3%)
YTD Earnings: $1.7 billion (-31%)
Comments: Results for the quarter and YTD were negatively impacted by the launch of generic clopidogrel bisulfate (Plavix) and loss of exclusivity of Pravachol. Plavix sales were down 36% and Pravachol sales were down 64% in the quarter. Erbitux, Abilify, Sustiva, Reyataz and Avapro/Avalide and sales of new products Orencia, Baraclude and Sprycel, all performed well in the quarter. In the quarter, BMS and Gilead Sciences submitted Atripla for regulatory approval in Canada. The company launched Baraclude for the treatment of chronic hepatitis B virus infection in Germany, France, the UK and Japan. Also, BMS and Sanofi-Aventis received approval from the FDA and the EMEA for an additional indication for Plavix.
Millennium Pharma
3Q Revenues: $104 million (-48%)
3Q Loss: $13.7 million (loss of $73.8 million 3Q2005)
YTD Revenues: $346.7 million (-20%)
YTD Loss: $52.2 million (loss of $154.3 million YTD2005)
Comments: Velcade sales in the quarter were $53.2 million, up 5%. Velcade was recently approved for marketing in Japan for relapsed or refractory multiple myeloma. The company's sNDA for Velcade was recently granted priority review by the FDA for relapsed mantle cell lymphoma. R&D expenses were $70.4 million, down 9% in the quarter.
Posted on October 25, 2006 @ 10:00 am
Stem Cell Sciences (SCS) has entered an exclusive license agreement for
Millipore to develop and market SCS' serum-free media for the growth of human embryonic stem cells (hESCs). This media will be the first product available in the industry that offers improved methods for growing hESCs without the need for animal serum.
Researchers can generate improved experimental results by avoiding interference from animal products in the media, which will also improve the reliability in growing hESCs. This will help researchers to better understand the therapeutic value of stem cells.
"Millipore is committed to being the most innovative supplier of products to the stem cell research market," said Dominique Baly, president of Millipore's Bioscience Division. "Our agreement with SCS reflects the significant investments we are making to serve the needs of researchers exploring the therapeutic value of stem cells. We chose SCS because their media worked extremely well in growing hESCs in a variety of different stem cell lines and conditions and they had the most advanced development of serum-free media."
Under the terms of the agreement, Millipore will manufacture and market the new media under the brand name HEScGRO Embryonic Stem Cell Medium. SCS will receive royalties from all future sales of HEScGRO. The company expects to have HEScGRO available for commercial distribution before the end of the year.
SCS vice president and chief operating officer Hugh Ilyine said, "As researchers investigate using stem cells to create cures for new diseases, the use of hESCs are critical. By providing serum-free media to grow hESCs, scientists can be confident that the effects they are studying in the laboratory are from the cell itself and not from animal products in the media. The expansion of our agreement with Millipore will allow researchers to now benefit from products offering superior performance in both mouse and human stem cell research."
Posted on October 25, 2006 @ 09:58 am
SAFC Pharma business segment, a member of the Sigma-Aldrich Group, has been appointed by
Curalogic to provide protein isolation, extraction and purification services related to the development of products focused on allergic rhinitis.
Curalogic will seek to develop pharmaceuticals that are just as effective as injection immunotherapy and also offer patients the convenience and safety equal to that of the best symptomatic treatments. Key products include a ragweed pollen extract that has just completed Phase II trials, a grass pollen extract and cat extract currently in Phase II, and a house dust mite extract that is in preclinical trials. These compounds have the potential to treat a variety of allergies.
SAFC Pharma will begin initial phases of the project at the St. Louis protein purification and extraction facility. These phases explore development of grass and house dust mite compounds to determine a suitable process for producing sufficient quantities of cGMP material for future clinical trials and commercial launch of these products. Subsequent phases of the Curalogic project will be transferred into SAFC's new cGMP protein extraction and purification facility after its scheduled completion in April 2007.
Ove Pedersen, executive vice president of development at Curalogic, said, "We are looking forward to working with SAFC in this field, as process development is such an important area for biological products. SAFC's expertise in development of products derived from natural-sourced materials will be of great value to Curalogic."
Frank Wicks, SAFC president, said, "This appointment by Curalogic for protein purification and contract research is the perfect fit for our new protein extraction and purification pilot plant facility currently under construction in St. Louis. SAFC is a recognized leader in cGMP extraction and purification of therapeutic proteins from natural-sourced material, and we are pleased to act as Curalogic's partner for the development and manufacturing of these allergy products."
Posted on October 25, 2006 @ 09:56 am
Viron Therapeutics, Inc. has signed an agreement with
Diosynth Biotechnology for process development, scale-up, and clinical manufacturing for its lead product candidate, VT-111, currently in Phase II trials for the treatment of inflammation associated with Acute Coronary Syndrome (ACS).
"We are very pleased to be working with Viron," said Frank Tielens, president of Diosynth Biotechnology. "Our experience in technology transfer, in process development and in cGMP production and our regulatory history have certainly been noticed and appreciated by the industry." Mr. Tielens added, "Because of these strengths, we have been rewarded with innovative customers such as Viron whose VT-111 product was recently identified as one the 10 most promising cardiovascular drug candidates in development."
"We have entrusted Diosynth with the clinical manufacturing of our lead drug candidate, VT-111, as they have proven themselves to be world leaders in this area," stated Neil K. Warma, president and chief executive officer of Viron. "The manufacturing process developed will ultimately support pivotal trials and the eventual market launch of VT-111, which is currently being tested in a multi-center Phase II trial, and we are pleased to have such a strong partner in Diosynth," added Mr. Warma.
Posted on October 24, 2006 @ 10:08 am
Cambrex Corp. has entered into an agreement with
Lonza Group AG for the sale of its bioproducts and biopharma segments for $460 million in cash. The sale of the bio businesses, which is subject to Cambrex stockholder approval and customary regulatory approvals, is expected to close during the next few months.
The bioproducts business manufactures and markets research, therapeutic and analytical testing products based on cell biology used in drug discovery and biotherapeutic manufacturing. The biopharma business offers process development services and contract manufacturing under cGMP conditions for therapeutic proteins, vaccines and other biologic drugs.
James A. Mack, chairman, president and chief executive officer of Cambrex, said, "We are pleased to announce the successful completion of this important phase of our strategic review. After a thorough and deliberate process, our board of directors determined that the sale of our bio businesses to Lonza represents the most compelling means for realizing value for Cambrex stockholders. In addition to receiving a substantial cash dividend, stockholders can look forward to additional benefits from their continuing investment in our strong Human Health business."
Stefan Borgas, chief executive officer of Lonza, said, "For Lonza, this is the largest acquisition in our long company history and represents a significant commitment and leap forward toward achieving our long-time goal of becoming one of the world's leading suppliers to our existing and new customers in the pharmaceutical, healthcare and other life science industries. We are now closer to this goal than ever before."
Posted on October 24, 2006 @ 10:06 am
Solvay Pharmaceuticals has renewed its clinical development alliance with
Quintiles Transnational Corp. for another five years. First signed in 2001, the renewal reflects the success in accelerating development of Solvay's product portfolio and improving efficiency.
Through the alliance, Solvay has completed three Phase III programs, moved two compounds from Phase II to Phase III earlier than expected, and produced conclusive Phase II data that resulted in the termination of two other programs, freeing resources for other development work.
"Using Quintiles' global infrastructure and experts as a strategic asset, we've advanced projects at a much faster rate than we could have achieved alone, and with greater flexibility," said Werner Cautreels, chief executive officer of Solvay Pharmaceuticals. "Over the next five years we aim to achieve even higher levels of value in terms of efficiency, speed and cost-savings."
Quintiles chairman and chief executive officer, Dennis Gillings, Ph.D., CBE, said, "This alliance shows the power of strategic partnering to create a more efficient and flexible drug development platform. Both Solvay and Quintiles are focused on a single goal -- moving products efficiently through development and on to patients in need. This renewal demonstrates the progress we've made and our shared passion to achieve that goal."
Posted on October 24, 2006 @ 10:02 am
Wyeth has signed an agreement with
Affymetrix to use its GeneChip microarray technology for three more years, extending the relationship that began in 1994. Under the agreement, Wyeth will continue to apply Affymetrix technology in numerous areas of the drug discovery and development process.
Wyeth, one of the first pharma companies to apply genomics in clinical research, will continue to use Affymetrix microarray technology to identify new drug targets in an effort to gain a better understanding of the genetic markers that correlate with a patient's response to therapy. The latest GeneChip technology enables Wyeth to more accurately classify disease, predict clinical progression and determine likelihoods of treatment success in ways never before possible.
"Wyeth has been a pioneer in demonstrating the power of Affymetrix microarray technology in the entire drug discovery and development process," said Chip Leveille, vice president, pharmaceutical business unit at Affymetrix. "We anticipate that a better understanding of human genetic variations and the ability to look at the entire genome in greater detail will dramatically accelerate research and, ultimately, help bring more effective tests and therapies to market faster."
Posted on October 23, 2006 @ 10:21 am
Eli Lilly and Co. completed the first phase of a $560 million expansion to its biotech complex in Indianapolis. The investment is part of a $1 billion effort to strengthen and build its biotech drug R&D capabilities. Lilly's plans for the complex, announced in 2002, have since doubled in size to meet its pipeline of biopharma drugs. Approximately 30% of Lilly's total drug portfolio are biopharma medicines in several therapeutic categories.
With the state-of-the-art bioproducts pilot manufacturing plant, the company aims to bring advanced biotech medicines to patients through more efficient, productive and dependable manufacturing processes. The company has also opened a research support facility that 700 scientists, engineers and support staff will relocate to.
"These investments reinforce Lilly's position as a biotech leader," said John Lechleiter, Ph.D., Lilly's president and chief operating officer. "In tandem with our rich history of biotechnology, they give us a competitive advantage to discover, develop, and launch important new biotech therapies."
The construction of the three buildings, along with Lilly's acquisition of Applied Molecular Evolution in 2004, accounts for a total biotech capital investment of approximately $1 billion. "These investments, part of the company's planned growth strategy in the area of biotechnology, prove that Lilly is confident in its future in biotech," said Dr. Lechleiter.
Posted on October 23, 2006 @ 10:19 am
Astellas Pharma, Inc. has chosen
Medidata Solutions Rave 5.5 as its standard global solution for all clinical studies in Phases I-III during the next five years. Astellas plans to implement clinical trials using Medidata Rave 5.5 across North America, Asia, Europe and other regions.
According to the company, the selection was based on Medidata's understanding of the requirements of the global clinical development process and its reliable and secure hosting and help desk services and support. Medidata Rave 5.5 is able to support Astellas' global initiatives on a single scalable platform by offering the flexibility to allow clinicians to capture, manage and report on clinical data simultaneously in the languages of their choice, including support for complete Japanese character sets.
"We were impressed with Medidata's plan in the Japanese market and the company's unique ability to manage paper trials as well as electronic trials," said Mitsutoshi Mukai, vice president of data science at Astellas. "With a reliable, scalable and user-friendly technology, Medidata is able to handle our diverse profile of global trials and allow us to focus on our core business of designing clinical programs." Rave 5.5's Double Data Entry (DDE) feature will allow Astellas to collect both paper and electronic data in a single database, which provides global access for collaboration and monitoring of activities across various organizations and geographies.
Rave 5.5's Local Language Translation Workbench will also eliminate translation procedures and allow users to work in their native language against a single, global, centrally-managed repository of clinical data.
"We are deeply honored for Medidata Rave to have been chosen as Astellas' electronic clinical data management solution, and share in their vision for streamlining a wide range of clinical trials. This relationship further highlights our success and commitment to delivering outstanding levels of service, quality and reliability," said Tarek Sherif, chief executive officer of Medidata Solutions. "Medidata's infrastructure was built to flexibly and cost-effectively scale up or down to manage trials of any size within a company's portfolio, and we look forward to collaborating with the Astellas team as they standardize their global clinical trial procedures using Rave."
Posted on October 23, 2006 @ 10:18 am
AstraZeneca received approval from the FDA for Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel was previously approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. Seroquel is now the first and only single medication approved by the FDA to treat both depressive and acute manic episodes associated with the disorder.
More than seven million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.
The approval was based on results from the clinical trial program known as BOLDER (BipOLar DEpRession). In these studies, patients taking Seroquel showed an improvement in depressive symptoms starting at week one compared to those taking placebo, and this improvement continued throughout the eight-week study. Patients treated with Seroquel also showed significant improvement on other measures of efficacy including overall quality of life and satisfaction related to functioning.
Posted on October 20, 2006 @ 11:11 am
Takeda Pharmaceuticals North America, Inc. has opened its new, 70-acre corporate home office in Deerfield, IL. The new property is the first phase of construction, which includes a 380,000 sq.-ft. campus consisting of two buildings housing more than 800 employees.
"We are celebrating yet another milestone for Takeda. In just eight years, the company quickly grew in the U.S. from three employees to more than 3,000, establishing itself as the one of the fastest-growing pharmaceutical companies in the U.S.," said Mark Booth, president of Takeda Pharmaceuticals North America, Inc. "This remarkable growth drove the need for a new campus to help support our continued success, and we are pleased to have found a home in Deerfield."
"The opening of the new Takeda home office in the U.S. is one of our greatest achievements for establishing and enhancing our U.S. business," said Kunio Takeda, chairman of the board of Takeda Pharmaceutical Co., Ltd. "This event represents the realization of a long-cherished dream passed down from our predecessors to the current management and throughout the 225-year history of Takeda." The company was awarded more than $15 million in Opportunity Returns support by the Illinois Department of Commerce and Economic Opportunity (DCEO).
Posted on October 20, 2006 @ 11:10 am
Cambrex Corp. has signed an agreement to sell two non-strategic facilities within its Human Health segment to a holding company controlled by International Chemical Investors II S.A. (ICIG) of Luxembourg.
The facilities, which are located in Cork, Ireland and Landen, Belgium, manufacture small molecule APIs and advanced intermediates. The transaction is expected to close within 30 days.
"As part of our evaluation of strategic alternatives, we identified the divestiture of Cork and Landen as an initial step in our effort to streamline and strengthen the Human Health business," said James Mack, chairman, president and chief executive officer of Cambrex. "This transaction will allow us to focus our Human Health investment in our three largest facilities where we have strong market positions, differentiating technologies, and proprietary products. We believe that under ICIG's leadership and experience in this industry bringing to bear synergies with their other activities, combined with the dedicated workforce at the sites, the new owners will achieve the full turnaround in the foreseeable future."
Posted on October 20, 2006 @ 11:06 am
Merck & Co.
3Q Revenues: $5.4 billion (flat)
3Q Earnings: $940.6 (-34%)
YTD Revenues: $16.6 billion (+2%)
YTD Earnings: $4 billion (+13%)
Comments: Worldwide sales for Singulair were $868 million for the quarter, up 25%. Combined global sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership, exceeded $1 billion for the quarter. Vaccine sales were $555 million, up 64% as a result of the launch of Rotateq, Zostavax and Gardasil, and the strong performance of Proquad. Restructuring costs were $49.6 million for the quarter. The company reserved an additional $598 million in the quarter for future Vioxx legal defense costs.
Schering-Plough
3Q Revenues: $2.6 billion (+13%)
3Q Earnings: $309 million (earnings were $65 million 3Q2005)*
YTD Revenues: $7.9 billion (+11%)
YTD Earnings: $940 million (earnings were $143 million YTD2005)
Comments: Sales increase for the quarter was driven by growth in prescription pharmaceuticals, including higher sales of Remicade, Nasonex and Temodar. Remicade sales were up 34% to $317 million. Nasonex sales were up 30% to $221 million. Temodar sales were up 18% to $179 million. Global cholesterol joint venture sales, which include Vytorin and Zetia, reached more than $1 billion in the quarter.
*3Q2005 results included a charge of $124 million related to an R&D payment for exercising rights to develop and commercialize golimumab.
Posted on October 19, 2006 @ 11:47 am
Pfizer plans to implement a company-wide cost-reduction initiative to lower its cost base in 2007 and 2008, in an effort to provide more flexibility in the face of changing market conditions. This new initiative is in addition to the Adapt to Scale (AtS) initiative. By 2008, these savings will be more than $4 billion and as a result, the company expects an average annual growth to be in the high single digits over 2007-08, though revenues are expected to stay flat during that span. According to the company, by 2009 it expects a return to revenue growth as the impact of major patent expirations declines and the performance of new products becomes more significant in the marketplace.
Pfizer's chief executive officer, Jeffrey B. Kindler said, "Pfizer is a strong company with a bright future. We will continue to invest in a wide and promising range of opportunities for growth. Our pipeline of new products and new approaches to discovery and development, coupled with our strategy of acquiring attractive new products and technologies externally, promise to deliver strong and renewed growth opportunities over time. By moving quickly now to transform our company, we will enhance our competitive strength and put ourselves in the best possible position to capitalize on all the opportunities available to us."
Posted on October 19, 2006 @ 11:45 am
Covalent Group, Inc. has signed multiple Phase I and Phase II contracts valued at $8.2 million. All of the contracts are with the same client and relate to the development of an agent to treat multiple types of influenza, including Avian Flu. Services include consulting on clinical trial design and protocol development, project and study site management, field operations, data management, and biostatistical support.
Kenneth M. Borow, M.D., chief executive officer and president for Covalent Group, commented, "We are exceptionally proud of our involvement in this important development program which we believe could ultimately prove to be beneficial to millions of people worldwide. These contract wins were the result of highly coordinated business development and clinical operations efforts on the part of Covalent Group and Remedium Oy, a privately owned, full-service CRO based in Espoo, Finland that we expect to acquire. We believe that these contract wins represent a strong proof-of-concept that the combination of Covalent and Remedium, resulting in the newly created company Encorium Group, Inc., will be a highly competitive force in the drug development and CRO marketplaces."
The closing of the Remedium transaction is targeted for November 1, 2006 and is subject to the approval of Covalent Group's shareholders.
Posted on October 19, 2006 @ 11:36 am
Wyeth
3Q Revenues: $5.1 billion (+9%)
3Q Earnings: $1.2 billion (+33%)
YTD Revenues: $15.1 billion (+8%)
YTD Earnings: $3.3 billion (+14%)
Comments: Enbrel sales, outside of the U.S. and Canada, were $378 million for the quarter and $1.1 billion YTD, increases of 37% and 38%, respectively. Prevnar sales were $510 million for the 2006 third quarter and $1.5 billion for the 2006 first nine months, increases of 30% and 32%, respectively. Effexor sales were $924 million for the 2006 third quarter and $2.8 billion for the 2006 first nine months, increases of 7% and 6%, respectively. Protonix sales were $452 million for the quarter and $1.4 billion YTD, increases of 12% and 9%, respectively. Methylnaltrexone received fast track designation from the FDA in the quarter for the treatment of post-operative ileus.
Lilly
3Q Revenues: $3.9 billion (+7%)
3Q Earnings: $873.6 million (+10%)
YTD Revenues: $11.4 billion (+6%)
YTD Earnings: $2.5 billion (+12%)*
Comments: Revenue growth in the quarter was driven by Cymbalta, Zyprexa and other newer products. Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve, collectively grew 45% to $959.7 million. Diabetes care revenue, including Humalog, Humulin, Actos and Byetta, increased 9% to $712.4 million. Gemzar sales were $354.6 million, up 6%.
*The 2005 year-to-date amounts are adjusted to exclude the $1.1 billion second-quarter product liability charge, which includes the $690 million for the previously announced Zyprexa product liability settlement as well as reserves, primarily related to Zyprexa. These charges have been offset by estimated recoveries from the company's insurance coverage.
Baxter
3Q Revenues: $2.6 billion (+7%)
3Q Earnings: $374 million (earnings were $116 million in 3Q2005)
YTD Revenues: $7.6 billion (+3%)
YTD Earnings: $965 million (+45)
Comments: Growth in the quarter was driven by the company's BioScience business, with sales of $1.1 billion, up 15%. Renal sales were up 6% to $519 million. In the quarter, the company signed a definitive agreement for the sale of its Transfusion Therapies business for $540 million.
Serono
3Q Revenues: $699 million (+9.5%)
3Q Earnings: $170.6 million (+20%)
Comments: Product sales grew 8% to $619.2 million. Rebif sales were up 19% to $374.8 million. Sales of Raptiva were up 81% to $18 million. Novantrone sales were $2.8 million, down 85% due to generic competition. In the quarter, the company in-licensed safinamide in early Phase III in Parkinson's Disease.
Gilead Sciences
3Q Revenues: $748.7 million (+52%)
3Q Loss: $52.2 million* (earnings were $179 million 3Q2005)
YTD Revenues: $2.1 billion (+50%)
YTD Earnings: $475.7 million (-11%)
Comments: Product sales were a record $670.1 million for the quarter, up 43%, driven by its HIV franchise with sales up 53% to $557.3 million. Truvada sales were $309 million, up 90%. Atripla, launched in July, reached sales of $68.4 million. Sales of Hepsera totaled $55.1 million for the quarter, up 18%.
*Loss in the quarter included a charge of $355.6 million for purchased in-process research and development (IPR&D) incurred in connection with the acquisition of Corus Pharma.
Pfizer
3Q Revenues: $12.3 billion (+9%)
3Q Earnings: $3.4 billion (+112)
YTD Revenues: $35.8 billion (+3%)
YTD Earnings: $9.9 billion (+85%)
Comments: Lyrica growth continues with worldwide sales reaching $340 million in the quarter compared to $80 million in 3Q2005. Worldwide sales of Lipitor were up 15% to $3.3 billion. Worldwide sales of Celebrex reached $537 million, up 20%. Chantix for smoking-cessation and Exubera, inhalable insulin, were launched in the quarter. The withdrawal of Bextra, beginning in 2005, continued to affect revenues.
Posted on October 18, 2006 @ 10:26 am
Merck received approval from the FDA for Januvia for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either metformin or thiazolidinediones (TZDs), to improve blood sugar control in patients with type 2 diabetes when diet and exercise is not enough. It is the first and only DPP-4 inhibitor available in the U.S.
Januvia enhances a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, Januvia works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.
Posted on October 18, 2006 @ 10:24 am
Abbott
3Q Revenues: $5.6 billion (+3.5%)
3Q Earnings: $715.8 million (+5%)
YTD Revenues: $16.3 billion (flat)
YTD Earnings: $2.2 billion (-8.5%)
Comments: Adjusting for the Boehringer Ingelheim (BI) distribution amendment, U.S. pharmaceutical sales increased nearly 17%, driven by Humira, Omnicef, Depakote, Kaletra and TriCor.* Global Humira sales were $541 million, up 52%, with U.S. sales up 43% and international sales up 66%. Results for the quarter include acquired in-process R&D of $214 million related to the Guidant vascular acquisition.
*In August 2005, Abbott amended its co-promotion and distribution agreement for the three BI products: Mobic, Flomax and Micardis. As of Jan. 1, 2006, Abbott no longer distributes these products and no longer records sales for distribution activities.
Posted on October 18, 2006 @ 10:21 am
Brecon Pharmaceuticals has commissioned its tenth
Romaco blister packer. The platen-sealing Noack 623 has been installed as part of a complete line incorporating a Romaco Promatic PC 4200—the first UK installation for this cartoner. A second PC 4200, also for inline connection to a Noack 623, has been delivered. Both lines feature checkweighers from OCS, represented in the UK and Irish healthcare markets by Romaco UK. Romaco provides expertise in processing, filling, dosing and packaging solutions for the pharmaceutical and cosmetics industries.
According to the company, the latest installations offer additional capacity and the higher throughput needed to support its continued growth and to satisfy the diverse international client requirements. The Promatic PC 4000 range of continuous motion horizontal cartoners has a variety of features to maximize GMP compliance, including full balcony construction.
Steve Kemp, business development director at Brecon, stated, “We need to be able to accommodate a wide range of batch sizes on one hand, while on the other, we can expect longer runs as customers use outsourcing strategically. We must also address job-specific requirements, such as complex mixed fills, or the use of special materials, such as those designed for compliance with recent legislation on child-resistance.”
“Ongoing investment in technology and increased automation is essential if we are to maintain efficiency while addressing ever-increasing quality, regulatory and customer expectations,” said operations director Andrew Billington. "Romaco has an excellent understanding of the industry’s needs, reflected in the robust and reliable design of equipment right across its portfolio. Our partnership with Romaco is key in our mission to deliver the best possible service to our clients.”
Posted on October 17, 2006 @ 10:13 am
MDS Pharma Services has established its first central lab in the U.S., expanding its capabilities in late-stage pharmaceutical testing. The new 15,000-sq.-ft. facility, located in North Brunswick, NJ, is now fully operational and provides central lab support services for clinical trials.
In addition to standard safety testing, this facility provides esoteric testing including molecular biology, molecular genetics, flow cytometry, and immunoassays. These complex tests are used in drug development to evaluate targeted treatments for conditions such as cancer, autoimmune diseases, diabetes, and immune deficiencies.
"We established this lab to meet the growing demand from clients for a facility in the U.S. that offers both standard and complex testing to support the development of new treatments," said MDS Pharma Services president, David Spaight. "This location is easily accessible to many pharmaceutical companies headquartered in the Northeastern U.S. It can accommodate clients who conduct clinical trials in and outside the country."
The new lab has received accreditation from the College of American Pathologists (CAP) and also received a Level 1 certification from the National Glycohemoglobin Standardization Program for providing the highest levels of technical precision and accuracy in standard diabetic testing. This test is used to assess a diabetic's overall wellbeing and to monitor the effectiveness of diabetic treatments.
Posted on October 17, 2006 @ 10:10 am
Eli Lilly and Co. has signed a definitive merger agreement to acquire
ICOS Corp., based in Bothell, WA, in a cash transaction valued at $2.1 billion. The two companies have been partners in Lilly ICOS LLC, the joint venture that manufactures, markets and sells Cialis, an oral PDE-5 inhibitor for the treatment of erectile dysfunction. Cialis generated worldwide sales of $456 million in the first six months of 2006, up 34% over the first half of 2005.
"We are pleased to bring the full value of Cialis to Lilly and to continue providing the benefits of Cialis to men suffering from erectile dysfunction," said Sidney Taurel, Lilly's chairman and chief executive officer. "We have had a very successful and productive relationship with our partners at ICOS and are looking forward to taking this next step. With full ownership of Cialis, we will be able to realize operational efficiencies in the further development, marketing and selling of this important product. We expect this acquisition will increase the company's earnings and earnings growth rate beginning in 2008 and, after a significant addition to sales in 2007, will modestly accelerate the company's sales growth rate thereafter."
Paul Clark, chairman, president and chief executive officer of ICOS, stated, "Our talented people grew ICOS, over 16 short years, into one of the top-tier biotech companies in the U.S. Along the way, they collaborated to create and commercialize one of the few blockbuster drugs to come from biotech. The acquisition by Lilly, our close partner for nearly a decade, provides a compelling financial outcome for our shareholders."
The transaction is expected to close in late 2006 or early 2007 and is subject to approval by ICOS shareholders, clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and certain other closing conditions.
Posted on October 17, 2006 @ 09:50 am
Quintiles Transnational Corp. plans to open a central lab in Mumbai, India to expand its global network of labs that support global and regional clinical trials. The new lab is expected to be ready in the first quarter of 2007. The lab is located in Leela Business Park in Mumbai together with Quintiles' core clinical research and electrocardiogram (ECG) businesses.
Ferzaan Engineer, chief executive officer of Quintiles India, said the new lab in Mumbai will contribute to the continued growth of the regional business. "Since its inception in 1997, our core clinical research business has grown exponentially due to strong customer demand for quality investigator sites in India," said Mr. Engineer. "The new central laboratory in Mumbai will enhance the suite of services we offer in India, which include ECG, interactive voice response (IVR) and data management services as well as clinical research." The India company has about 675 employees in offices in Bangalore, Mumbai and Ahmedabad.
The Mumbai lab will provide access to Quintiles laboratory kits, ensure all study samples are processed and completed using consistent methods and will oversee the data transfer for inclusion in the company's Laboratory Information Management System (LIMS) and the protocol-specific database.
Posted on October 16, 2006 @ 10:03 am
Edmund P. Harrigan, M.D. has been promoted to senior vice president of worldwide licensing and business development for
Pfizer. The group will have overall responsibility for co-promotion and licensing agreements, venture capital investments in new technologies and the acquisition of promising new products and services from outside the company.
"While Pfizer's core scientific capabilities are outstanding, the explosion in medical science and related technologies around the world means that we now have many more opportunities for strategic investments," said David Shedlarz, vice chairman of Pfizer. "Worldwide Licensing and Business Development brings together previously separate functions so that all the capabilities and resources necessary to evaluate and secure these opportunities are in one place, with a clear strategy and accountability.
Dr. Harrigan, a board certified neurologist, has served as senior vice president of worldwide regulatory affairs and quality assurance at the company since 2003. He joined the company in 1992 and spent nine years in Phase II and III clinical development trials related to the central nervous system. He also led a team in achieving the approval of Pfizer's new generation antipsychotic medicine Geodon. In 2003, he served as vice president, worldwide medical neuroscience and ophthalmology, where he focused on marketed drugs and late-stage development candidates in those therapeutic areas.
Dr. Harrigan also held the positions of senior vice president of medical operations at Sepracor and executive vice president and chief development officer at Neurogen Corp.
Posted on October 16, 2006 @ 09:56 am
Patheon, Inc. has entered into an agreement with its lenders to restructure certain financial agreements under its North American loan facilities in an effort to continue its business.
The 12-month credit agreement, to be satisfied monthly, covers a six-month period from October 31, 2006 to March 31, 2007, at which point the company plans to have implemented a long-term improvement to its capital structure.
"With this amendment in place, Patheon has the financial flexibility to continue to operate our business effectively and in compliance with our loan agreements. At the same time, we will continue to pursue strategic alternatives that will serve the interests of our shareholders, clients, and employees," said Mr. Riccardo Trecroce, chief executive officer, Patheon. "We are making progress on the strategic review process announced last month, and we intend to complete this process during the period covered by the amendment to the credit agreement."
As of September 30, 2006, $252.4 million was outstanding under the North American loan facilities. As part of the amendment, the loan facility was reduced from $75 million to $60 million. Also, at September 30th, $42.3 million was borrowed under this facility. The company had $49 million of cash reserves at this time and according to the company, is confident it has sufficient liquidity to carry on its business.
Posted on October 16, 2006 @ 09:53 am
Eisai and
Pfizer received FDA approval for an sNDA for Aricept for the treatment of severe Alzheimer's disease (AD). With this approval, Aricept becomes the only prescription medication to treat mild, moderate and severe AD. Aricept, which is co-promoted in the U.S. by Eisai and Pfizer, has been approved in the U.S. since 1996 for treatment of mild to moderate AD.
The approval was based on results from a multi-center, randomized, double-blind, placebo-controlled trial involving 248 patients with severe AD. Patients treated with Aricept had statistically significant benefit compared to those taking placebo in both primary efficacy measures: the Severe Impairment Battery for cognition and the Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease for function/activities of daily living.
Posted on October 13, 2006 @ 09:54 am
Parexel International has entered a definitive purchase agreement to acquire the business and operations of
California Clinical Trials Medical Group, Inc. (CCT) and Behavioral and Medical Research, LLC (BMR) for $65 million. CCT and BMR provide a broad range of specialty Phase I-IV research services through four clinical sites in CA and are headquartered in San Diego. The acquisition is expected to close within the next 30 days.
"The acquisition will further strengthen our global Clinical Pharmacology Network with the addition of 51 Phase I beds on the West Coast," stated Josef von Rickenbach, chairman and chief executive of Parexel. "A 35-bed unit located on the campus of the Glendale Adventist Medical Center, combined with an additional 16 beds that are currently under construction at another location, will expand the company's Clinical Pharmacology capacity to over 400 beds, making Parexel one of the largest providers of Phase I services in the world. The deep experience that CCT and BMR have with central nervous system clinical trials and neuroscience drug development services, combined with their expertise in performing complex studies, will enhance the services we currently provide to clients."
Robert Palko, president and chief operating officer of CCT and BMR, noted, "Joining forces with Parexel should enable us to access a much broader client base for our specialized Phase I through IV services, and provide us with the ability to present our clients with a more extensive product and service offering to meet their diverse needs. We look forward to better leveraging our specialized expertise as we integrate our company with Parexel's robust consulting and clinical research services portfolio."
Posted on October 13, 2006 @ 09:51 am
Gene Logic has entered into a drug repositioning and development agreement with
Eli Lilly and Co. to seek alternative development paths for multiple Lilly drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety.
The agreement provides for milestones and royalties similar to those paid for development-stage in-licensing deals, discounted to account for Lilly's contribution as the originator of the compound. Gene Logic will the option to receive an exclusive license to any drug candidate that Lilly chooses not to pursue, in which case Lilly would receive success-based milestone and royalty payments.
Gene Logic's Drug Repositioning Program offers partners an approach to strengthen their pipelines with high-quality drug candidates that originated from their own R&D efforts. The company's program evaluates drug candidates for potential utility across a wide spectrum of disease indications.
Mark Gessler, Gene Logic's chief executive officer, commented, "We are very pleased to have Lilly as our fourth major pharmaceutical partner. The goal of our program is to provide partners with substantial value; clearly this message is resonating with large pharmaceutical companies and is establishing Gene Logic as a leader in drug repositioning."
Posted on October 13, 2006 @ 09:50 am
Roche has initiated the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has also been granted Fast Track designation by the FDA.
R1626 uses a different mechanism of action from the current standard HCV treatment and has been shown to have a strong antiviral effect. In a Phase I study, the drug achieved significant reductions in viral levels in chronic hepatitis C patients infected with genotype 1, the most difficult to treat form of the virus. Patients with genotype 1 virus in clinical trials with Roche's currently available hepatitis C therapies, Pegasys and Copegus, had an approximate 50% chance of achieving a sustained virologic response (SVR). There is still a strong medical for new therapies to improve these response rates. The trial will evaluate the safety and antiviral effect of R1626 in combination with Pegasys and Copegus.
Posted on October 12, 2006 @ 10:07 am
Genzyme
3Q Revenues: $808.6 million (+14%)
3Q Earnings: $16 million (earnings were $115.7 million 3Q2005)*
YTD Revenues: $2.3 billion (+16%)
YTD Earnings: $251 million (-25%)
Comments: Myozyme was a significant new contributor in the quarter with the first full quarter of sales $20.4 million. Fabrazyme, Aldurazyme, Cerezyme and Renagel also contributed to revenue growth in the quarter. Sales of Fabrazyme rose 18% to $93.2 million. Sales of Aldurazyme rose 24% to $25 million. Sales of Cerezyme were $252.2 million, up 6%. Renagel sales were up 26% to $134.7 million in the quarter.
*Earnings for the quarter include a charge of $149.4 million for the impairment of goodwill associated with the company's genetic testing business; an amortization expense of $31.9 million; and a stock compensation expense of $30.3 million.
Posted on October 12, 2006 @ 10:06 am
Genentech received approval from the FDA for Avastin to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), the most common type of lung cancer. The approval is based on a Phase III study (E4599) that showed Avastin in combination with chemotherapy resulted in a 25% improvement in overall survival compared to chemotherapy alone.
"Bevacizumab, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA-approved therapy ever to extend survival for these patients beyond one year in a large, randomized clinical study," said Alan Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, TN and lead investigator on the E4599 trial. "With this survival benefit, bevacizumab represents an important therapy for many advanced lung cancer patients fighting this difficult disease."
Posted on October 12, 2006 @ 10:04 am
The EMEA has completed implementation of
Sparta Systems' TrackWise software to support its integrated quality management (IQM) system. TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool for electronically logging, managing, and trending quality and regulatory issues and action items. The software centralizes quality processes into an integrated system, helping organizations increase efficiencies and achieve compliance by linking and consolidating related events and actions, automating workflow, and facilitating trending and reporting across quality systems and related organizational areas.
The EMEA implemented TrackWise to electronically manage critical quality-related processes including Audit Management, Audit Observations Tracking, Action Item Tracking and management of Standard Operating Procedures. TrackWise replaced paper-based and Microsoft Excel-based systems previously used by the agency. Also, the EMEA plans to deploy TrackWise to manage global risk management analysis and other activities related to the IQM system.
"We are proud to have the EMEA in production with TrackWise," said Yaniv Vardi, vice president, operations of Sparta Systems Europe. "The four-month implementation is a testament to the collaborative relationship between Sparta Systems and the EMEA, as well as to the flexibility and performance of TrackWise. We are excited that the EMEA is already reaping the benefits of its investment."
"We are pleased with the quick and smooth implementation and the overall breadth of the TrackWise solution," stated Claus Christiansen, integrated quality management auditor of the EMEA.
Posted on October 11, 2006 @ 09:33 am
DSM Biologics and
Argenes, Inc., headquartered in Tokyo, Japan, have signed a biopharmaceutical manufacturing agreement. Under the terms of the agreement, DSM will provide Argenes with full process development services, analytical development services and manufacturing batches for Argenes’ Anti-Fas IgM monoclonal antibody. The services will be provided out of DSM Biologics’ FDA-approved manufacturing facility in Groningen, The Netherlands. Argenes’ Anti-FAS IgM monoclonal antibody is being developed as an anti-rheumatic agent.
“The agreement is a further reinforcement of the strong and mutually beneficial relationship between Argenes and DSM Biologics. We gladly entrust DSM with the execution of this agreement that is crucial for the success of our Anti-Fas IgM monoclonal antibody,” said Kamishohara, president and chief executive officer of Argenes.
“DSM Biologics is very pleased to be involved in this exciting project. The agreement is a clear recognition of the value that DSM Biologics has brought, and will continue to bring to Argenes, an important client for DSM Biologics,” said Terry Novak, chief marketing officer of DSM Biologics.
Posted on October 11, 2006 @ 09:29 am
Tunnell Consulting has opened an office in San Diego, CA to serve the area's biologic, biotech, device and diagnostic industries. The PA-based company assists life sciences companies in the U.S. and Europe with technical and development services including manufacturing optimization, compliance support, risk mitigation and clinical and regulatory strategy.
The San Diego office will be headed by
Carmen Medina, a Tunnell principal with extensive knowledge in biologics and biotechnology gained through 20 years of government, industry, and academic experience. Prior to joining the company in 2006, Ms. Medina was the president and founder of Precision Consultants where she actively supported major initiatives by FDA, Department of Defense, and FDA-regulated industries, which included the development and approval of an Anthrax vaccine and the commercialization of hundreds of pharmaceuticals and novel devices.
"Our new operations in San Diego enable us to more effectively assist our clients in implementing innovative therapeutic solutions and delivering extraordinary results," said Joseph S. Tempio, Ph.D., Tunnell's president and chief executive officer. "Carmen's strong FDA experience with team biologics and experience as a global Pre-Approval Inspection (PAI) investigator is precisely the type of expertise many of the areas' companies need to bring their products to market."
"Tunnell offers its clients experience and insight as well as highly specialized abilities integral to the optimization of any company's progress and operating performance," said Carmen Medina. "Having an office in San Diego will allow us to better serve our expanding West Coast client base. Our continued growth here, and across the country, is the result of superior services provided by a team of highly skilled people dedicated to the objectives of our clients."
Posted on October 11, 2006 @ 09:25 am
The FDA has approved
Merck's Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Zolinza is manufactured by
Patheon, Inc. in Mississauga, ON.
Zolinza was approved as part of FDA's Orphan Drug program, which offers companies incentives to develop medications for diseases affecting fewer than 200,000 Americans a year.
Evidence of Zolinza's safety and effectiveness was developed in two clinical trials with 107 CTCL patients who received Zolinza after their disease had recurred following other treatments. A response, defined by improvements on a scale that scores skin lesions, occurred in 30% of patients who received Zolinza and lasted an average of 168 days.
Posted on October 10, 2006 @ 10:12 am
Quebec-based
Confab Laboratories has successfully undergone its second FDA audit for the manufacture and supply of pharmaceutical products to the U.S. The audit was a preapproval inspection for three drug products and demonstrated the company's conformity to cGMP. Confab's main focus is to provide manufacturing solutions for nonsterile conventional dosage forms with an efficient turnaround.
Confab’s chief executive officer, Guy Lamarre, commented, "The future looked bright, but this will be a key driver in sustaining our company’s growth in the long term." The company has increased the size of its facility by 20% in 2006 and is planning its next expansion to meet the needs of its clients and the industry. This year Confab has invested $5 million in its facilities.
Posted on October 10, 2006 @ 10:09 am
Pfizer has entered into an agreement to acquire
PowderMed Ltd., a UK-based company specializing in the emerging science of DNA-based vaccines. PowderMed has developed a technology to deliver DNA directly to the cells of the body's immune system and is advancing a promising pipeline of vaccine candidates for influenza and chronic viral diseases.
"This acquisition is a strategic opportunity to enter the vaccine market and is part of our focus on broadening healthcare solutions for patients," said Jeffrey B. Kindler, chief executive officer, Pfizer. "There is a critical public health need for new, more effective vaccines to prevent and treat infectious diseases. As understanding of the human immune system continues to grow exponentially, PowderMed is on the leading edge of advances in vaccine technology that may lead to new vaccines for infectious diseases."
"I am delighted that the potential of the PowderMed technology to revolutionize the prevention and treatment of infectious diseases is now in the hands of the world's leading pharmaceutical company," said Dr. Clive Dix, founder and chief executive officer, PowderMed. "This agreement is a testament to the hard work and commitment of the PowderMed employees over the years."
Financial terms were not disclosed. The acquisition is subject to customary closing conditions and is expected to close during the fourth quarter of this year.
Posted on October 10, 2006 @ 10:04 am
SommaTech LLC, a pharmaceutical technology consulting firm, has been formed as a new affiliate of
IPS, an engineering firm for the pharma and biopharma industries. SommaTech’s team of specialists will serve the pharma, biopharma, and medical device industries, as well as combination products, diagnostics, food supplements and natural products. Key service areas are drug development, operations and compliance. SommaTech will also provide a full range of business support for its clients including due diligence for products, quality risk analysis and processes, methods development, and life cycle management.
“After 30 years of experience in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management, it was clear that the industry demands a consulting firm such as SommaTech,” said Russ Somma, Ph.D., president, SommaTech.
Posted on October 9, 2006 @ 10:49 am
Sigma-Aldrich Corp. has acquired
Advanced Separation Technologies, Inc. (Astec). The acquisition will add chiral chromatography capabilities and product line, enabling the Sigma-Aldrich's Research Specialties business units to better support the analysis and purification of chiral compounds. Terms of the cash transaction were not disclosed.
"In addition to a wide range of proprietary chiral chromatography products, the acquisition of Astec brings the specialized knowledge of chiral separations embodied in its people," commented Russel Gant, vice president for Sigma-Aldrich's chromatography manufacturing site in Bellefonte, PA. "This enables our Research Specialties business to continue to expand the value we deliver to the scientific community."
Chiral chromatography is used to resolve chiral compounds from racemic mixtures into pure enantiomers. This method is often used for analysis and purification of chiral compounds in research, development, production and quality control.
Posted on October 9, 2006 @ 10:44 am
Pfizer CentreSource (PCS) has finalized supply agreements for selected steroid APIs with Asian contract manufacturers
ScinoPharm Taiwan, Ltd. of Tainan, Taiwan and
Shanghai Pharmaceutical Co., Ltd. of Shanghai, China. In November 2005 PCS made plans to transfer the manufacture of selected products to Asia as part of an effort to provide customers with an optimal balance of product cost, quality, and regulatory compliance standards.
Under the terms of both agreements, Pfizer will transfer the manufacturing of 18 steroid products during the next three years to the Asian suppliers. Pfizer will continue the early stage bioconversion operations at its plant in Kalamazoo, MI and will transfer later-stage processing to ScinoPharma and Shanghai Pharma to enable more cost-efficient production.
"By working with such well respected suppliers, PCS will be able to bring more competitively priced steroid APIs to the global market," said Michael Kosko, president, PCS.
Doris Symonds, vice president of global marketing for PCS Fine Chemicals, said, "Our new strategy combines Pfizer's long standing technical strengths in early-stage processing with the lower cost chemical processing capabilities of respected Asian contract manufacturers. This new approach allows us to serve the long-term needs of our customers for controlling product costs.
Posted on October 9, 2006 @ 10:35 am
Bilcare has acquired DHP Ltd., a clinical trials service provider based in Powys, UK. DHP specializes in the manufacture, import, storage and distribution of Phase I-IV investigational medicinal products for the pharma, biopharma and CRO industries. This includes a full range of Qualified Person (QP) services to support product lifecycles, from design through reconciliation and destruction. DHP also provides GMP/GCP compliant services and works in accordance with the EU Clinical Trials Directive.
Mohan Bhandari, chairman and managing director of Bilcare, commented, "Bilcare has been successful in living up to its commitment of providing a truly worldwide operating network to the global pharmaceutical sector and partnering with them to enhance their speed-to-market by best in class local management of global clinical trials."
Steven A. Jacobs, president of Bilcare added, "This acquisition gives us the ability to fulfill global customers' needs, providing quality support that enables them to manufacture, package, test, store and distribute clinical supplies in the EU. It also provides DHP with the ability to do the same in the U.S. and India, while adding a full range of analytical and Interactive Voice Response System (IVRS) capabilities to their clinical supply chain. The greatest achievement from this venture is the perfect alignment of quality systems, people, processes and values that both companies hold in high regard. Working together will be a seamless collaboration which is what customers are looking for in the clinical supplies and services industry."
Posted on October 6, 2006 @ 09:35 am
Wyeth Pharmaceuticals has submitted an NDA to the FDA and a marketing authorization application (MAA) to the EMEA for Torisel for the treatment of patients with advanced renal cell carcinoma (RCC).
The registration dossier contains interim data from a Phase III trial of 626 patients who had received no prior systemic therapy. The primary end point of the study was overall survival. The results showed treatment with Torisel increased median survival by 3.6 months, or 49%, compared with treatment with interferon-alpha (10.9 months vs. 7.3 months). The final analysis will also be submitted to regulatory authorities at a future date.
Torisel is an investigational drug that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth and cell survival. If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer.
In July 2004, the FDA granted fast track designation for Torisel for first-line poor prognosis subjects with advanced RCC, and in December 2004 it was granted orphan drug designation for the treatment of RCC. In March 2006, Torisel received Orphan Medicinal Product designation for the treatment of RCC in the EU.
Posted on October 6, 2006 @ 09:33 am
IBT Laboratories has named
Michelle Hunter, Ph.D., M.B.A. vice president of sales, marketing and corporate development. Dr. Hunter, an experienced clinical research scientist and pharmaceutical executive, is responsible for guiding the company’s business development and marketing initiatives. She is also responsible for heading up the expansion of the company's clinical trial testing services that target the pharmaceutical, biopharmaceutical and contract research markets.
“Dr. Hunter brings to IBT a unique blend of clinical research and executive leadership experience in the global pharmaceutical industry,” said John F. Halsey, Ph.D., the company’s president and chief executive officer. “IBT will leverage her vast expertise across these disciplines to meet the explosive market demand for contract immunology research and testing. Dr. Hunter’s broad perspective and knowledge of the industry will enable us to develop and deliver new solutions that further help our clients streamline their R&D processes, reduce development costs and bring drugs to market faster.”
Dr. Hunter’s pharmaceutical experience includes seven years in strategic account sales and executive sales management at PRA International. Most recently, she held the position of vice president of global business development and marketing at Focus Bio-Inova, a specialty microbiology and central laboratory serving the international pharmaceutical market. In a clinical capacity, Dr. Hunter was integral in the global clinical development of two neuroscience compounds at Bristol-Myers Squibb. She has also held research scientist positions at the University of Connecticut and held an adjunct faculty position in the university’s psychology department for eight years.
Posted on October 6, 2006 @ 09:31 am
Array BioPharma, Inc. has appointed
April H. Teitelbaum, M.D., MS, FACP, to the newly created position of vice president of clinical development, oncology. Dr. Teitelbaum will oversee the medical strategy and clinical development of the company's oncology drug pipeline and will report to the company's chief executive officer, Robert E. Conway.
"April's solid track record and experience in developing new cancer drugs will be invaluable to Array as we advance our extensive drug pipeline," said Mr. Conway. "April's expertise in running complex clinical trials will be a competitive advantage for Array as we are on track for having five drugs in clinical development by the end of 2006."
For the last 16 years, Dr. Teitelbaum has held positions of increasing responsibility for clinical and strategic development of oncology therapeutics at several pharmaceutical and biotechnology companies including Amgen, Sequus Pharmaceuticals, Ligand, Johnson and Johnson, and Kyowa Pharmaceuticals. She has been involved in clinical development, including registration strategies and expansion of label for multiple oncology therapeutics, including Neupogen, Doxil, and Yondelis. Dr. Teitelbaum also headed her own consulting company and has served as a consultant to several companies for development of novel oncology therapeutics. Prior to that Dr. Teitelbaum was engaged in private practice, specializing in Hematology and Medical Oncology.
Posted on October 5, 2006 @ 09:54 am
MDS, Inc. has signed an agreement to sell its Canadian Diagnostic Services business to
Borealis Infrastructure Management, Inc. in a $1.2 billion transaction. This sale is part of the company's strategic shift to focus on the life sciences market and streamline its cost structure to be more competitive.
“The sale of our diagnostics business represents a major milestone for MDS in the transition to a global life sciences company,” said Stephen P. DeFalco, president and chief executive officer, MDS. “We will be able to focus exclusively on life sciences markets, where incredible advances are being made to diagnose and treat diseases. This agreement represents a great outcome for our shareholders, our employees and the customers we serve.”
“We see an exciting future for this business,” said Michael Rolland, senior vice president of Borealis. “We look forward to working with the talented professional staff at MDS Diagnostic Services to ensure that they continue to lead the industry in the delivery of laboratory services that support the healthcare needs of Canadians.”
The transaction, subject to customary approvals and conditions, is expected to close by the end of January 2007.
Posted on October 5, 2006 @ 09:51 am
Genentech, Inc. has appointed
Leonard Kanavy vice president, commercial operations and has promoted
Anthony P. Hurley to vice president, fill/finish manufacturing.
Mr. Kanavy will report to Ian T. Clark, executive vice president, commercial operations. In this role, he will be responsible for leading the market planning, forecasting, sales operations, data acquisition, commercial training, commercial business processes, thought leader management and market communications groups.
Mr. Kanavy joins the company from Novartis Pharmaceuticals, U.S. where he was vice president of commercial operations. He held several leadership roles at Novartis, including vice president of business analysis, executive director of market analysis, and director of specialty marketing research and analysis.
Mr. Hurley will report to Timothy L. Moore vice president, South San Francisco manufacturing. In this role, he will continue to lead the South San Francisco (SSF) commercial and clinical fill/finish operations, and will have overall responsibility for Genentech's future fill/finish facility in Hillsboro, OR, which is expected to be licensed and operational in 2010.
Mr. Hurley joined the company in 2005 as senior director, parenteral manufacturing facility. He has had increasing responsibilities, including leading the packaging operations, and most recently, the SSF manufacturing and utility instrumentations operations teams.
Prior to joining the company, Mr. Hurley was site director for GlaxoSmith Kline's anti-infectives operation and held various manufacturing operations and strategic planning positions during his 17 years' with the company.
Posted on October 5, 2006 @ 09:49 am
Curis, Inc. and
Genentech have filed an IND application with the FDA to initiate Phase I testing of a systemically administered small molecule Hedgehog antagonist for the treatment of cancer.
Under the terms of the June 2003 collaboration agreement, Genentech will pay Curis $3 million cash after filing the IND application. Should this small molecule drug candidate progress successfully through development and gain regulatory approval, Curis will be eligible to receive additional cash payments. Curis would also receive royalties on any product sales.
"We believe that the IND filing demonstrates Genentech's continued interest in the importance of the Hedgehog pathway as a potential therapy for the treatment of various cancers," said Curis president and chief executive officer Dan Passeri. "We're extremely pleased that our Hedgehog antagonist collaboration with Genentech has produced a clinical candidate for systemic administration and we are looking forward to working with Genentech in seeking to advance the drug candidate through the clinic. Cancer is a serious healthcare challenge in the U.S., and we are hopeful that our Hedgehog antagonist technologies will one day provide an effective treatment for a variety of cancers."
Posted on October 4, 2006 @ 09:28 am
Millipore Corp. has opened a new $50 million R&D center in Bedford, MA as part of its strategy to leverage cutting edge technologies, extend its applications expertise, and to meet the growing demands of the global biopharmaceutical market and the life sciences industry.
“Our new Bioprocess R&D Center is a demonstration of our commitment to MA and our continuing investment in technologies and facilities that will help us to deliver innovative, quality products to our customers,” said Martin Madaus, chairman and chief executive officer of Millipore. “Over the past two years, we have begun to transform Millipore into a more innovative organization with new capabilities to meet the changing needs of our industry. The opening of this center continues this transformation, enabling us to attract the best scientific talent and bring together multiple research disciplines to develop integrated solutions. These solutions will create value for our biotechnology and pharmaceutical customers and fuel our continued growth as a leader in the life sciences industry.”
The Bioprocess division is designed to help companies optimize manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Also, with this new center, the company is able to develop full-scale applications performance data and processes that simulate commercial conditions that can result in increased speed and quality of biopharmaceutical production.
The state-of-the-art 110,000 sq.-ft. building contains 47,000 sq.-ft. of lab space, and consolidates multiple functions. As many as 500 professionals will work in the new facility.
Posted on October 4, 2006 @ 09:21 am
Pall Corp has plans to expand its Life Sciences manufacturing operations in Fajardo, PR in order to meet increasing demand by pharmaceutical and biotechnology companies, blood centers and hospitals. The company expects to invest approximately $50 million in facilities, machinery and equipment and add more than 250 full-time jobs in PR by 2010.
The expansion in PR is part of the company’s standardization and consolidation efforts with respects to its global manufacturing business. The company anticipates that PR’s competitive tax rate combined with its facilities optimization program will result in an incremental after tax benefit of more than $10 million annually in three years.
Eric Krasnoff, chairman and chief executive officer of Pall, stated, “Puerto Rico’s attractive business climate and strong commitment to developing biopharmaceutical manufacturing capability are key factors in bringing numerous drug and biotechnology companies to the island. Expanding our operations in Puerto Rico is an important part of our strategic approach of aligning with customers worldwide and increasing production in lower tax rate jurisdictions.”
Posted on October 4, 2006 @ 09:14 am
Eurand has entered into a development and license agreement with
GlaxoSmithKline to use its Microcaps taste-masking and AdvaTab oral disintegration tablet technologies to develop a new formulation of an undisclosed GSK product.
Under the terms of the agreement, GSK will fund the development of the product and Eurand will receive royalties on product sales. GSK will have exclusive commercialization rights in the U.S., and both companies will have certain rights to commercialize the product outside of the U.S. Eurand will retain exclusive, worldwide manufacturing rights. The companies plan to begin clinical trials in 2006 and apply for marketing authorization in the U.S. by the end of 2007.
GSK will pay Eurand a total of as much as $42 million based upon achievement of certain development, regulatory and sales milestones. Additional terms have not been disclosed.
Gearoid Faherty, chief executive officer of Eurand, commented, "We are delighted that GSK has chosen Eurand for this important project, we believe it further confirms our market leading position in the fields of taste-masking and oral disintegrating tablets. The combination of our Microcaps and AdvaTab technologies has received an enthusiastic reception from industry leaders such as GSK and we are currently in advanced contract negotiations with companies in Japan, Europe and the U.S. for a range of different products."
Posted on October 3, 2006 @ 09:33 am
SAFC Pharma, a member of the Sigma-Aldrich Group, is expanding its cCMP protein purification capacity to meet market demand for therapeutic proteins from plant- and animal-sourced starting materials. When completed in April of 2007, the natural and recombinant plant protein purification facility will be one of the world's largest therapeutic protein production sites.
The new operations, part of a 400,000 sq.-ft St. Louis, MO manufacturing campus, will feature separate plant and animal protein processing facilities to eliminate potential cross-contamination. A natural and recombinant plant proteins facility will occupy 22,000 sq.-ft. for its upstream and downstream processing operations. Also, there will be a 20,000 sq.-ft. animal-sourced proteins facility for upstream processing. This will be supported by an area that contains more than 300,000 sq.-ft. of total capacity. Downstream animal-sourced purification will take place in an adjacent 5,000 sq.-ft. clean room suite.
"SAFC is a recognized leader in cGMP purification of therapeutic proteins from natural-sourced material," said SAFC president, Frank Wicks. "Recent successes in the transgenic plant market combined with advancements of several of our natural APIs derived from plants have provided impetus to expand our capacity. We have several projects moving into late-stage clinical trials and commercial manufacturing and are expanding to meet growing customer demand."
SAFC recently expanded its capacity and technology with the purchase of the SAFC Arklow, Ireland facility; a large-scale API manufacturing site with 90,000 liters of total cGMP capacity; the acquisition of SAFC Pharmorphix, a Cambridge, U.K.-based solid-state research company; and an $18 million dollar expansion of the SAFC Madison high-potency chemistry facility.
Posted on October 3, 2006 @ 09:28 am
Xanthus Pharmaceuticals, Inc. has licensed from Schering AG the exclusive right to develop and commercialize oral fludarabine in the U.S.
Oral fludarabine is currently marketed by Schering AG in the EU and Canada under the name, Fludara, for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL). Intravenous (IV) fludarabine has been available for several years as a single treatment for patients with CLL whose disease has relapsed following prior therapy. The IV formulation was approved in 2003 for first-line treatment, and the approval for the oral formulation was extended to first-line treatment in Europe in November 2004. Schering AG studied oral fludarabine in several trials as a first- and second-line therapy, where it showed an efficacy and tolerability profile similar to that of the IV formulation.
"We believe oral fludarabine is an excellent strategic fit with our expanding oncology pipeline. With the convenience of oral dosing added to the current standard of care for refractory CLL patients, we believe oral fludarabine represents a relatively low-risk, near-term commercial opportunity for Xanthus," stated Robert L. Capizzi, M.D., senior vice president and chief medical officer at Xanthus.
Under the terms of the agreement, Xanthus paid Schering an upfront licensing fee and has agreed to make payments upon the achievement of predetermined milestones, as well as pay a royalty to Schering on net sales. Additional financial terms were not disclosed.
Posted on October 3, 2006 @ 09:26 am
GlaxoSmithKline’s sNDA for its anticoagulant product Arixtra Injection has been accepted for priority review by the FDA. This application was based on positive results from two Phase III trials (OASIS 5 and 6) that evaluated Arixtra in the treatment of a broad spectrum of patients with acute coronary syndromes (ACS).
The filing submission data included the OASIS 5 trial results, which compared Arixtra to Lovenox (enoxaparin) in patients with UA/NSTEMI, and OASIS 6, which compared Arixtra to standard therapies (unfractionated heparin or placebo) in STEMI patients.
"GSK is very encouraged by the FDA's decision, based on these two ground- breaking trials with Arixtra in ACS," said Dr. Lawson Macartney, senior vice president, Cardiovascular and Metabolic Medicine Development Centre, GSK. "This application supports our commitment to patients, physicians and the cardiovascular community. We look forward to building on our existing indications with Arixtra."
Posted on October 2, 2006 @ 09:41 am
Amgen has entered into a definitive merger agreement to acquire
Avidia, Inc. for $290 million in cash. The transaction provides Amgen with Avidia's lead product candidate, an inhibitor of interleukin 6 (IL-6) for the treatment of inflammation and autoimmune diseases, which is in Phase I trials. Avidia is a biopharmaceutical company that discovers and develops a new class of human therapeutic known as Avimer proteins.
Under terms of the agreement, Amgen will also pay as much as $90 million upon the achievement of certain milestones. Following the completion of the transaction, Avidia will become a wholly owned subsidiary of Amgen.
"The Avimer technology is among the most attractive protein-based technologies currently under development," said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president for R&D. "Avimers may have several advantages as therapeutic products in terms of biological activity, tissue distribution, reduced immunogenicity and improved manufacturing efficiencies."
"I am very pleased with this transaction, which demonstrates the enormous value and potential of the Avimer protein technology platform as a groundbreaking new way to develop drugs," said Peter Van Vlasselaer, Ph.D., Avidia's chief executive officer. "We are looking forward to becoming part of the world's leading biotechnology company. Amgen's abundant resources and expertise will enable us to develop our technology and clinical programs to their full capacity."
The transaction, subject to customary closing conditions, has been approved by the boards of directors of each company and is expected to close in the fourth quarter of this year.
Posted on October 2, 2006 @ 09:37 am
Dr. Marcello DiMare has been named to the new position of senior director, chemistry development within
Aptuit's API business line. This follows the company's recent acquisition of EaglePicher Pharmaceutical Services, expanding its API and drug development capabilities to include chemical process development, clinical trial supply of API and post-launch commercial drug manufacture.
Dr. DiMare brings 25 years of experience gained through his work at a variety of pharmaceutical companies in the U.S. and Europe. Dr. DiMare most recently served as senior director of business development at Dr. Reddy's Laboratories and held senior positions at Rhodia ChiRex and ChiRex, Inc.
"Marcello offers a remarkable mix of expertise in chemical development, as well as the proven management know-how necessary for us to continue to expand our API and drug substance manufacturing capabilities and fulfill our vision of providing customers with truly integrated, full-service drug development solutions," said Michael J. Butler Ph.D., president, scientific operations at Aptuit. "Throughout his career, Marcello has demonstrated his ability to assess opportunities from both a scientific as well as business perspective."
Dr. DiMare will concentrate on building Aptuit's process development and custom syntheses business, focused on post-discovery preclinical and clinical trial custom API synthesis and supply. He will also build and extend the radiolabeling expertise acquired from EaglePicher. Also, in Phase I of Aptuit's Kansas City build-out, Dr. DiMare will recruit 12 to 18 chemists to fill-out the company's newly-designed GLP laboratories, and will consolidate Aptuit and EaglePicher's capabilities.
"Aptuit is realizing its mission to offer market-leading API drug substance manufacturing capabilities and this is an exciting opportunity for me to lend my experience and skill-set to identify and secure resources necessary to provide customers with state-of-the-art API technologies and innovative solutions to address their unique challenges," noted Dr. DiMare.
Posted on October 2, 2006 @ 09:35 am
Genentech, Inc. and
Biogen Idec, Inc. received approval from the FDA for two additional uses for Rituxan for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
In February 2006, Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy was approved as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Rituxan was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20- positive, B-cell NHL.
September 2006
Posted on September 29, 2006 @ 06:37 am
Memory Pharmaceuticals has achieved a $2.0 million milestone related to its PDE10 collaboration with
Amgen, a strategic alliance entered into in October 2005 focused on the development of PDE10 inhibitors as potential treatments for certain neurological and psychiatric disorders. The achievement of the milestone was triggered by preclinical work on PDE10 inhibitors, which satisfied a set of criteria pre-defined by Amgen.
Separately, Memory Pharmaceuticals announced that Amgen plans to increase its research funding commitment for the second year of the PDE10 collaboration. Under the terms of the collaboration, Amgen committed $3.3 million in research funding over the first 12 months. Amgen is increasing its research funding commitment for the second year of the collaboration to $3.9 million.
"The achievement of this milestone and the increase in research funding reflect the productivity of this collaboration and the progress we are making with our partner Amgen in advancing the PDE10 program towards identifying clinical candidates," said David A. Lowe, Ph.D., Memory's chief scientific officer. "We continue to work with Amgen to identify lead candidates as treatments for serious neurological and psychiatric disorders."
The collaboration is focused on the optimization of lead compounds that Memory has identified and that have demonstrated effectiveness in the selective inhibition of PDE10 activity in several animal models. Under the terms of the agreement, Memory could receive additional significant milestone payments for the successful achievement of research, development, approval and sales events for compounds that progress under the collaboration. In addition, the company is eligible to receive royalties that will increase with increasing sales levels on worldwide sales of marketed products from the collaboration.
PDE10 is a class of phosphodiesterases that degrades cAMP and cGMP, molecules that are responsible for improving the function of many different cells in the body, including neurons. By inhibiting PDE10 activity, levels of cAMP and cGMP are increased within neurons, and the ability of these neurons to function properly is thereby improved. PDE10 has been shown to be present at high levels in neurons in areas of the brain that are closely associated with many neurological and psychiatric disorders.
Posted on September 29, 2006 @ 06:34 am
Bristol-Myers Squibb and
Gilead Sciences have made an agreement to commercialize their combo-drug Atripla in Canada for the treatment of HIV-1 infection in adults, subject to the approval of the product by Health Canada. Atripla is the first once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. It received approval from the U.S. FDA on July 12, 2006.
The agreement is the result of negotiations between BMS and Gilead and expands the companies' U.S. joint venture established in December 2004. The companies will work together to complete regulatory filings in Canada and will share responsibility for commercializing Atripla in Canada, subject to regulatory approval of the product. As in the U.S., both companies will provide funding and field-based sales representatives in support of promotional efforts for Atripla. Gilead will record revenues from future net sales of the product, while BMS will record revenues at percentages relative to the contribution represented by its individual product.
"This agreement with Gilead Sciences marks an important step forward in our efforts to deliver effective HIV therapies," said Lamberto Andreotti, president, Worldwide Pharmaceuticals, BMS. "We look forward to working with Gilead Sciences and Health Canada to make available another effective treatment option for Canadian adult patients living with HIV/AIDS."
Atripla combines Sustiva (manufactured by BMS) and Truvada (a fixed-dose product that contains two of Gilead's anti-HIV medications: Viread and Emtriva) in a single once-daily tablet for use as part of combination therapy.
Posted on September 28, 2006 @ 06:30 am
The FDA has approved
Amgen's Vectibix following priority review. Vectibix is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.
The approval of Vectibix was based on a progression-free survival endpoint. Vectibix is the first anti-EGFr antibody shown to significantly improve progression-free survival in patients with metastatic colorectal cancer. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix can be administered intravenously once every two weeks.
Vectibix is expected to be commercially available in early-to-mid October and will be priced at approximately 20% cheaper than
Erbitux, the other anti-EGFr antibody currently on the market.
EGFrs are proteins that play an important role in cancer cell signaling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGF receptors. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.
"Vectibix is the first entirely human antibody for the treatment of colorectal cancer to be approved by the FDA. It provides another option for patients with metastatic colorectal cancer that have progressed on all available chemotherapy regimens," said J. Randolph Hecht, M.D., director of the UCLA Gastrointestinal Oncology Program and clinical professor of Medicine, UCLA David Geffen School of Medicine, Los Angeles. "In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care."
Marketing applications were simultaneously submitted to the European Medicines Agency (EMEA) in April 2006 and Health Canada, Australia and Switzerland in May 2006. Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer.
Posted on September 28, 2006 @ 06:27 am
BASi (Bioanalytical Systems, Inc.) has reorganized its U.S. operations as part of its ongoing plan to reduce expenses, improve customer service and increase profitability. In addition to the realignment of operational and administrative responsibilities to increase efficiency, the company has implemented a workforce reduction aimed at reducing costs. Through attrition and layoffs that occurred during the past 60 days, including those made today, BASi has reduced its workforce by 12%. The company anticipates that the headcount reductions will result in cost savings of more than $2.0 million in fiscal 2007. A charge of approximately $500,000 associated with employee severance will be taken in the fiscal year ending September 30, 2006.
Commenting on the reorganization, executive vice president Edward Chait said, "With our new direction in Business Development we have focused on increasing revenues from diverse customers to reduce our concentration risk. With this reorganization we expect improved efficiency in delivering our products and services that will enhance our progress to profitability."
As part of the reorganization, chairman and chief executive officer Peter Kissinger announced that Richard M. Shepperd has been elected to serve as interim chief executive officer to help BASi add rigorous business discipline to company operations. Mr. Shepperd is an experienced, customer-focused, results-oriented executive with a proven track record in the pharmaceutical industry. Dr. Kissinger noted, "Dick has been helping us with planning for fiscal 2007, and we were fortunate to persuade him to stay on for the implementation. I am a scientist and an entrepreneur. As such, I will continue as chairman of the board and chief scientific officer, but let there be no doubt about it, Mr. Shepperd will be running and refining operations with our team of officers. In this competitive climate we need experienced help to drive profitability. Dick Shepperd is the right person to help us reorganize and think in new ways."
Posted on September 28, 2006 @ 06:23 am
The FDA has approved
Remicade for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter. In the Phase III clinical trial EXPRESS, eight out of 10 patients receiving Remicade 5 mg/kg induction therapy achieved 75% improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75) by week 10. Similar results were seen with EXPRESS II, the second Phase III study. These results were maintained by every eight-week Remicade 5 mg/kg maintenance infusions at six months. The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies. More than 1200 patients participated in the two Phase III clinical trials.
"The rapidity and consistency with which REMICADE can improve clearance of patients' skin is a major step forward for a patient population where persisting unmet needs in treatment exist," said Alice B. Gottlieb, MD, PhD, Dermatologist-in-Chief, Professor of Dermatology, Tufts-New England Medical Center, and pivotal U.S. study investigator. "As a researcher involved in the clinical investigation of REMICADE for the treatment of psoriasis, I've seen first-hand its significant results in improving psoriasis in the majority of patients treated."
Remicade is the first and only anti-TNF-alpha treatment to receive 13 FDA approvals across inflammatory diseases in gastroenterology, rheumatology and dermatology, and has now been used to treat more than 800,000 patients worldwide, more than all other anti-TNF agents combined, according to its maker,
Centocor, Inc., a
Johnson & Johnson subsidiary.
Posted on September 27, 2006 @ 09:57 am
Millennium Pharmaceuticals, Inc. has entered into an agreement to acquire
AnorMED, Inc. for approximately $515 million. AnorMED is a Canada-based biopharma company with a late-stage Phase III hematology-oncology product, Mozobil, which is currently in late-stage Phase III development. Subject to successful development and regulatory approval, the drug will be launched in the U.S. in 2008. Mozobil, a small molecule CXCR4 chemokine antagonist, works by releasing stem cells from the bone marrow into circulation, improving the ability to collect the stem cells for transplant.
"Mozobil is an excellent strategic fit with Millennium's focus in hematology-oncology, where our product Velcade leads the market in treating patients with relapsed multiple myeloma," said Deborah Dunsire, M.D., president and chief executive officer, Millennium. "This proposed acquisition is aligned with our goal to bring in products that accelerate revenue growth, leverage our oncology sales infrastructure and benefit from our development, regulatory and commercial expertise. We are extremely excited to carry forward the innovative work of the AnorMED team and to improve outcomes for transplant-eligible patients by bringing Mozobil to market."
Posted on September 27, 2006 @ 09:56 am
Steven Grieve has been named director/team leader, technical development and regulatory affairs for
Pfizer CentreSource. He will have global responsibility for the development of technical information, regulatory strategy and continuous technical support of PCS products. Mr. Grieve will be based in the PCS Kalamazoo, MI headquarters.
"Steve brings an exceptional depth and breadth of global regulatory, quality and technical expertise to his new role. He has been an asset to PCS and to Pfizer Global Manufacturing at every stage of his career, and we look forward to his continued success," commented Michael Kosko, president, Pfizer CentreSource.
Mr. Grieve, who joined the predecessor company, The Upjohn Co. in 1980 as a quality control professional, has subsequently held a number of positions of increasing responsibility, reflecting his expanding scope of expertise. Most recently he served as director/team leader, quality control systems.
Posted on September 27, 2006 @ 09:55 am
Pharm-Olam International Ltd. (POI), with the continued expansion of its data management and biostatistics services, has added new senior management positions.
Dr. Anthony Orlando, Ph.D. joins the company as vice president, Global Data Division, which oversees the company's data management and biostatistics services. Dr. Orlando brings an exceptional background in data management and biostatistics with more than 30 years of experience, which includes roles in pharmaceutical companies, the National Center for Toxicological Research/FDA, and CROs.
Louise Pitcher was appointed associate director of Clinical Data Management. She has worked as a data manager and project manager for the last 10 years for pharmaceutical companies and a CRO before joining the company. Ms. Pitcher has more than six years' experience of EDC technology, its system integration, process improvements and training. She joins the company from Procter & Gamble, where she managed many pivotal clinical trials in various therapeutic areas.
Posted on September 26, 2006 @ 10:19 am
Aptuit, Inc. has signed an agreement to acquire the assets and operations of
EaglePicher Pharmaceutical Services (EPPS) as part of its plan to build capabilities in API development and drug substance manufacturing. Aptuit will expand its API and drug development offering, building state-of-the-art API development scale capabilities in the EaglePicher facilities and in new facilities around the globe. The acquisition is expected to close within 90 days.
As part of the agreement, Aptuit will acquire EaglePicher’s facilities in Lenexa, KS and Harrisonville, MO. This acquisition will give Aptuit the ability to provide its customers with process development and novel route development, preclinical drug substance supply, clinical drug substance supply, radio synthesis, niche commercial supply, and technology transfer packages. The current facilities are configured to provide milligram, gram, kilogram, and tonne scale production.
"API is one of the key pillars in drug development," noted Michael A. Griffith, chief executive officer of Aptuit. "To promise a seamless drug development offering, you must first supply active ingredients, as all further development is dependent upon API. This acquisition represents a significant milestone for Aptuit and differentiates our offering as we seek to engineer a better drug development process. We intend to make significant investments in our new API operation over the next 18 months to upgrade the EPPS Harrisonville facility, extend its range of capabilities, and improve its regulatory profile. Additionally, we will be building a first class lab-based process development and kilo lab capability."
Stuart E. Needleman, senior director, API Development, said, "Drug development begins with synthesis of the molecule, making a successful API program critical to any drug development program. Our approach is to offer state-of-the-art technologies, industry leading talent, and a 'get it right the first time' mentality to accelerate customers through key milestones in the drug development process. Through the acquisition of EPPS, we gain infrastructure, systems, processes, and personnel, which will be the foundation as we continue to build our API offering."
Posted on September 26, 2006 @ 10:17 am
Pfizer and
Quark Biotech have entered into an agreement under which Pfizer acquires an exclusive worldwide license to Quark's novel human gene RTP-801 and to molecules that modify its expression or function. RTP-801 is involved in the development of pathologic blood vessels, which accelerate the progression of age-related macular degeneration (AMD). Financial terms of the agreement were not disclosed.
AMD is the leading cause of blindness in the developed world affecting about 15 million Americans over the age of 50. The target for RTP-801 is neovascular or wet AMD, the most devastating form of the disease. Based on preclinical models, AMD can potentially be treated by blocking the expression of the RTP-801 gene through RNA interference, a naturally occurring mechanism within cells for selectively silencing and regulating specific genes.
"Despite advances in research and the availability of new treatment options, there remains a need for new approaches to improve the lives of patients with AMD," said Martin Mackay, Ph.D., Pfizer senior vice president Worldwide Research and Technology. "We are excited about the potential of RTP-801 to preserve vision in patients with wet AMD who have an increased risk of progressive eye damage and vision loss."
"We are pleased that Pfizer has chosen our novel target RTP-801 and biomolecules for its drug development program," said Daniel Zurr, chief executive officer of Quark. "This agreement provides further recognition for Quark's creative approach to discover conceptually new drugs to treat devastating diseases. We are dedicated to help society with innovative medicines by moving from novel gene targets to unique compounds and eventually commercial products."
Posted on September 26, 2006 @ 10:16 am
John H. Bell, B.Comm., C.A., has been appointed chief financial officer of
Patheon, Inc. effective immediately. Mr. Bell will report to Riccardo Trecroce, chief executive officer.
"We are very pleased to welcome Mr. Bell to Patheon," said Mr. Trecroce. "He has extensive experience in developing and executing strategic plans from an operational as well as financial perspective. His specialized knowledge and depth of experience will be of significant benefit to Patheon. We look forward to his contributions as a member of our executive team."
Mr. Bell has considerable executive-level experience. During the past twenty years, he has held chief financial and operating officer positions with both public and private companies in several industries, including automotive parts, real estate and telecommunications.
Posted on September 25, 2006 @ 10:01 am
The FDA has approved a new use of
GlaxoSmithKline's anti-seizure medicine, Lamictal Tablets, for the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures, also known as "grand mal" seizures—one of the most serious forms of epilepsy. With this new indication, Lamictal can now be used as add-on therapy to treat PGTC seizures in children aged 2 and older as well as adults. This marks GSK's fifth FDA approval for Lamictal in epilepsy.
Posted on September 25, 2006 @ 09:59 am
MorphoSys AG's business unit,
AbD Serotec, has won a contract as sole source on a biodefense-related project by the USAMRIID, an organization of the U.S. Army Medical Research and Materiel Command and lead medical research laboratory for the U.S. Biological Defense Program. The USAMRIID has ordered fully human recombinant research antibodies against five bacterial-derived toxins. AbD Serotec will generate these antibodies using the HuCAL GOLD antibody library developed by MorphoSys. Financial details were not disclosed.
HuCAL GOLD technology utilizes a unique concept for the in vitro generation of highly specific and fully human antibodies. It's suited for a broad range of purposes from target validation to drug development, according to the company. It differs from traditional methods of antibody generation using animals in that recombinant HuCAL GOLD technology can deliver antibodies against toxic molecules.
"Securing this contract with the USAMRIID underscores the enormous potential of our proprietary HuCAL GOLD technology in the increasingly important biodefense field," commented Dr. Simon Moroney, chief executive officer of MorphoSys. "The project clearly speaks to one of several advantages of our recombinant antibody technology, in this case the generation of antibodies against toxins, which would not be possible with animal-based technologies."
Posted on September 25, 2006 @ 09:57 am
James T. Glover has been appointed to the new position of senior vice president of operations and chief financial officer,
Anadys Pharmaceuticals. He will be responsible for Anadys' operational and financial activities and will report to Kleanthis G. Xanthopoulos, Ph.D., president and chief executive officer.
Mr. Glover joins the company from Beckman Coulter, Inc., where he served as senior vice president and chief financial officer since 2003. During his 23-year tenure at Beckman Coulter, he was responsible for numerous finance activities.
"I am very pleased to welcome Jim to Anadys' experienced management team," said Dr. Xanthopoulos. "His financial knowledge and experience, as well as his operational management skills, are exceptional. I am confident that he will make an outstanding contribution at Anadys in the years ahead."
"I am delighted to become a member of the Anadys team," said Mr. Glover. "During my meetings and conversations with the senior management and board members of Anadys, I've been impressed with the strength of the company's dedication to developing innovative and powerful medicines for viral diseases and cancer. I look forward to contributing to that vision and commitment."
Posted on September 22, 2006 @ 10:28 am
Cardinal Health has entered a feasibility agreement with
Wyeth, through its Wyeth Pharmaceuticals division, to develop cell lines using its Gene Product Expression (GPEx®) cell line engineering technology.
Cardinal Health will use its GPEx technology to engineer cell lines that express two undisclosed biopharmaceutical molecules in experiments that will determine if the GPEx approach will work with Wyeth's current production methods. Financial terms of the agreement were not disclosed.
"Wyeth has taken a leadership position among major pharmaceutical companies to seriously move into large molecule therapeutics and has a great track record with biopharmaceutical R&D, manufacturing and commercialization,” said Paul Weiss, Ph.D., president of Cardinal Health's biopharmaceutical development services center. "We feel confident that the speed and high expression capabilities of our GPEx technology will be attractive to Wyeth as they evaluate additional platforms to rapidly and cost-effectively produce biopharmaceuticals.”
Posted on September 22, 2006 @ 10:25 am
A three-month business review by
Gene Logic, has confirmed the potential of its drug repositioning and restructured genomics units. According to a company statement, its genomics assets are a key part of the technology platform used in its drug repositioning business. The company is exploring the possibility of using the assets and technologies in areas such as clinical biomarker development and molecular diagnostics.
According to Gene Logic, the review revealed that its prior strategy for turning around the deteriorating genomics business would not reverse declining sales. Also, the restructuring of the unit -- including eliminating half of its work force and cutting spending -- has left the business focused on core competencies.
The business review has also confirmed the potential of its drug repositioning business, seeking to revive high-quality drug candidates stalled in clinical development for reasons other than toxicity, according to the company.
Posted on September 22, 2006 @ 10:23 am
SCOLR Pharma has entered into a research collaboration with a U.S.-based biopharma company to develop an oral formulation of a promising antiviral compound using its proprietary CDT® drug delivery platform. The compound under development has the potential to be used as a treatment against influenza. The goal of the program is to enhance the bioavailability of the compound to facilitate oral administration. If successful, the parties expect to enter a license agreement, which would provide for the potential commercialization of the product.
Alan M. Mitchel, SCOLR Pharma's senior vice president, said, "We believe this collaborative agreement is another important affirmation of the breadth of our proprietary CDT drug delivery technology. We look forward to working closely with our partner on this potentially important new pharmaceutical application. This is our fourth partnering relationship announced over the last several quarters."
Posted on September 21, 2006 @ 10:10 am
Merck KGaA has entered into an agreement to purchase
Serono shares for $13.3 billion in cash, as part of an effort to create a strategic combination. Subject to antitrust review and closing of the purchase, Merck will hold 64.5% of the capital of Serono and 75.5% of the voting rights. Together with Serono, Merck adds R&D capabilities, a multiple sclerosis franchise, expanded geographic reach with access to the U.S. market, and biotechnology manufacturing.
"This acquisition transforms Merck's pharmaceuticals business and creates a leading position in the world of biologic medicines, which helps to ensure its future through the 21st century," said Michael Roemer, chairman of the executive board of Merck KGaA. "Both companies have a unique opportunity to achieve a competitive advantage through a combined $1.25 billion R&D budget and a stronger product portfolio. The companies are a perfect fit with 28 compounds in development. Together with Serono management and employees, we will create a world-class biopharmaceutical company with global footprint, cutting-edge biotechnology manufacturing and strong growth."
Ernesto Bertarelli at Sorono said, "With this transaction we create a combined business with strong capabilities, especially in neurology and oncology. Together with Serono, Merck will be a world-class biotechnology company and a major player in the global pharmaceutical market. This match will allow Serono's innovative biotech abilities to play an important role in the future of the combined company while expanding its global reach."
Merck's Pharma Ethicals division will be combined with Serono to create Merck-Serono Biopharmaceuticals. The headquarters of this business will be in Geneva, Switzerland. Merck-Serono Biopharmaceuticals' U.S. headquarters will be in Boston, MA. The Merck Group will have a total of 35,000 employees.
Posted on September 21, 2006 @ 10:08 am
Hospira, Inc. has entered into an agreement to acquire
Mayne Pharma for $2 billion. The acquisition adds generic capabilities and broadens Hopsira's global reach.
"This combination will create the leading generic injectable pharmaceuticals company in the world—delivering unparalleled value to the global healthcare system as well as our respective shareholders and employees," said Christopher B. Begley, chief executive officer, Hospira. "The Mayne acquisition more than doubles Hospira's international presence and significantly accelerates the expansion of our generic injectables business."
"Mayne has grown rapidly over recent years and we believe will continue to grow under the ownership of Hospira, which will provide access to greater resources, particularly in the important U.S. market," said Peter Willcox, chairman, Mayne Pharma. "Hospira has a long heritage, much like our own company, and will encourage the development of our business to the benefit of our customers and employees."
The transaction is expected to be complete by the end of this year.
Posted on September 21, 2006 @ 09:59 am
ChemBridge Corp. and
ChemBridge Research Laboratories, Inc. (CRL) have entered into a multi-year chemistry discovery collaboration with
AstraZeneca. Under the agreement ChemBridge and CRL scientists at Moscow and San Diego research sites will work with AZ scientists to develop highly advanced exclusive small molecule libraries enhancing AZ's global drug discovery effort. Further details and financial terms were not disclosed.
"We are very pleased that after worldwide evaluation and due diligence AstraZeneca has selected ChemBridge and CRL as one of their chemistry partners," said Eugene Vaisberg, chairman and chief executive officer of ChemBridge Corp. and CRL. "This new agreement serves as yet another confirmation of the excellent capabilities of CRL and ChemBridge in the expertise-driven area of small molecule research. We look forward to contributing our proven chemistry expertise to AstraZeneca's global drug discovery program."
Dr. Paul Leff, vice president of discovery enabling capabilities and sciences, AstraZeneca adds, "We chose to work with ChemBridge and CRL because of their reputation and abilities in drug discovery chemistry and library synthesis. I am confident that we will see promising outcomes resulting from this collaboration in the area of lead generation."
Posted on September 20, 2006 @ 10:48 am
Metrics, Inc. is undertaking a $17.5-million facility expansion. The expanded facility will contain more analytical labs, an expanded microbiology lab, additional stability storage capabilities, approximately 9,000 sq. ft. of warehouse space and 17,000 sq. ft. of drug manufacturing space geared toward larger-scale clinical batch manufacture and commercial production. The 47,000-sq.-ft. expansion is expected to be complete in June 2007. The company plans to hire 77 new employees—a 45% increase in staff—to supplement its manufacturing and production capabilities during the next three years.
“We are extremely excited about this expansion, which represents an enormous milestone for Metrics,” said Phil Hodges, chief executive officer. “We have been working at capacity for some time. This new facility will allow us to not only expand current services, but also offer larger-scale clinical batch manufacture and commercial production."
Posted on September 20, 2006 @ 10:47 am
Ferro Pfanstiehl Labs, Inc., part of the Organic Specialties Group of Ferro Corp., has commissioned a new cGMP supercritical fluid-based particle engineering pilot facility. The facility brings additional expertise in particle sizing, purification and formulation to fee-for-service pharmaceutical and biopharmaceutical customers. It will provide ICH Q7A-compliant small-scale manufacturing of drug particles and compounds for use in Phase I and II trials and feasibility studies of engineered particles for any desired drug delivery application.
Ferro Corp.'s supercritical fluid (SCF) technologies utilize low-cost carbon dioxide to produce nano- and micro-particles with a narrow size distribution and consistent morphology. The particles manufactured using these technologies can be used in controlled release, taste masking, respiratory, transdermal and injectable drug delivery applications. Manufacturing benefits include reduced operating costs, near elimination of waste streams, easy recycling of organic solvents, and reduced cycle time.
"Ferro Pfanstiehl's cGMP SCF particle engineering facility is unique in offering a full tool box of technical approaches that will enable our customers to solve varied problems in drug development and delivery," said Peter Thomas, Ferro vice president of organic specialties. "It will allow them to develop and manufacture drug particles suitable for the fastest-growing drug delivery methods, such as inhalable, controlled release and injectable targeted therapeutics."
Posted on September 20, 2006 @ 10:45 am
Caprion Pharmaceuticals completed Phase I studies for Shigamabs, its product for the treatment of Shigatoxin-producing E. coli infections (STEC), including the O157:H7 strain involved in the current U.S. outbreak. The severe clinical symptoms such as hemorrhagic colitis, thrombocytopenia, hemolytic anemia and hemolytic uremic syndrome in as many as 60% of all infected patients, are potentially lethal in the most severe cases. Serious complications are most frequent in young children and the elderly. There are no treatments currently available for STEC infections.
The safety and tolerability of the company's anti-toxin antibodies were evaluated in 40 healthy adult volunteers. Shigamabs were shown to be safe and well tolerated in three studies conducted over the last four years at major medical centers in the U.S. and Canada.
Caprion is planning a Shigamabs trial in the EU and North America in 2007 pending final regulatory review.
Posted on September 19, 2006 @ 10:17 am
Amphora Discovery and
CHDI, Inc. have signed multiple agreements that provide CHDI access to Amphora Discovery's integrated contract discovery services. CHDI is seeking an approach to rapidly discover and develop drugs that prevent or slow Huntington Disease (HD), an inherited degenerative brain disease for which there is no treatment to delay or prevent its onset.
The agreements cover multiple biological targets implicated in HD and include access to Amphora Discovery's PrecisionScreen, PrecisionSelect and Full Hit-to-Lead services. Amphora will screen a large number of CHDI compounds against the implicated proteins using its PrecisionScreen technology. The PrecisionScreen data, combined with the parallel screening of the targets, will enable the primary data to be used for direct Structure Activity Relationship (SAR) mining. According to the company, this service avoids lengthy retest times and enables CHDI to rapidly select and prioritize the best chemical series for further development. Amphora Discovery will then use its PrecisionSelect profiling platform to further characterize any compounds of interest. The two companies will initiate a Full Hit-to-Lead program to structurally optimize multiple chemical series against all the implicated targets.
"Amphora Discovery is a highly experienced drug discovery partner with a validated process that delivers high quality data on reduced timelines. CHDI's mission is to support projects that hold specific potential for discovery and development of practical therapeutics ready for preclinical testing within a three- to five-year timeframe. We believe that Amphora Discovery's optimized drug discovery process provides us with the ability to achieve this goal," said Dr. Robert Pacifici, chief scientific adviser to CHDI.
Posted on September 19, 2006 @ 10:16 am
Gateway Chemical Technology, Inc. has been renamed IQsynthesis. The company provides custom synthesis and process development and assists the pharmaceutical, agrochemical and specialty chemical industries in the early phase production of molecules for research and development. The new name is part of a re-branding initiative by
Chemir Analytical Services, which acquired the company in May 2006.
“Clients have been requesting synthetic chemistry services, and we sought an acquisition to best fill this need,” explains Shri Thanedar, Ph.D., and chief executive officer of Chemir Analytical Services. “We chose the name IQsynthesis to emphasize the high caliber of scientists in this excellent organization. IQsynthesis also reflects our focus on innovation and quality, as we assist companies in the discovery and development of new molecules.”
“These molecules are the first steps in the development of new medications and therapies,” said Robert Kaufman, Ph.D., president of IQsynthesis. “We help large to virtual companies save time, stay on schedule, and attain their goal of creating molecules for a better life.”
Plans are underway to expand laboratory space and staff, as well as develop infrastructure and systems for cGMP regulated synthesis.
“As our Chemir group of companies serves more and more pharmaceutical clients, we understand the need for a broad and diverse offering of contract service providers,” says Dr. Thanedar. Currently, the Chemir group of companies include IQsynthesis, Chemir Analytical Services, Azopharma, a pharmaceutical contract service provider located in Florida, and CAS-MI, a laboratory serving the paints, coatings, and polymer industries, located in Michigan.
Posted on September 19, 2006 @ 10:13 am
Bentley Pharmaceuticals, Inc. has secured capacity at
Cardinal Health's North Raleigh, NC facility for the scale-up and manufacture of clinical supplies of its intranasal insulin product candidate, facilitating the expansion of clinical trials.
The product candidate utilizes Bentley's CPE-215 drug delivery technology to deliver insulin directly through diabetic patients' nasal mucosa using a small, discreet nasal spray. Cardinal Health will manufacture clinical supplies of Bentley's insulin product under cGMP at its new, sterile manufacturing facility in North Raleigh.
"This agreement with Cardinal Health is another important step forward in our intranasal insulin program and the CPE-215 delivery platform," said John A. Sedor, president of Bentley Pharmaceuticals. "Early results for the intranasal insulin product have been promising and there is growing interest in alternative insulin delivery methods that are less intrusive than injection. We are excited to be working with Cardinal Health to continue to advance this program through global Phase II trials this year."
"Bentley Pharmaceuticals leveraged multiple capabilities within Cardinal Health's development and manufacturing segment to prepare its intranasal insulin candidate for global clinical trials," said Shawn Gallagher, vice president and general manager of Cardinal Health's North Raleigh facility. "By using Cardinal Health's full range of solutions Bentley Pharmaceuticals maximizes its efficiency and relies on the same high-quality services through the entire drug development and commercialization cycle."
Posted on September 19, 2006 @ 10:10 am
AAIPharma, Inc. has entered an agreement to acquire
Cvitkovic & Associes Consultants S.A. (CAC), an international CRO specializing in oncology drug development and medical consulting, creating an AAIOncology business unit. CAC performs lead assessment of new analogs of established drugs as well as novel target-oriented compounds and has developed expertise in cancer therapies, including cytotoxics, cytostatics, monoclonal antibodies, cell-based therapies, vaccines, antiangiogenic agents, apoptosis inducers and hormonal therapies.
CAC brings to AAIPharma specialized, full-service capabilities in the early-stages of oncology drug development as well as in conducting large international Phase IIb/III studies. CAC is headquartered in Paris, France, and has offices in the U.S., Europe, and Latin America.
"The acquisition of CAC constitutes a major step in building a world class drug development organization that is focused on bringing content-rich and innovative services to its customers worldwide," said Ludo Reynders, Ph.D., AAIPharma president and chief executive officer. "In addition to expanding the company's therapeutic expertise, the capabilities of CAC complement the clinical services that AAIPharma currently provides its clients. We are committed to ensuring a smooth transition for CAC's customers, vendors and employees, and look forward to fully utilizing the new competencies and capabilities that CAC brings to accelerate and enhance the organic growth of our company."
Professor Esteban Cvitkovic, CAC chairman and founder, stated, "Having established our own model of clinical CRO services based on therapeutic specificity combined with medical and scientific know-how, CAC has now reached the limits of its organic growth. With AAIPharma, we can incorporate our oncology expertise and differentiation into a larger professional organization that shares our vision. The relationship between a CRO and industry must be a bridge between medical needs and new therapeutic possibilities. Passing on the successful critical mass of our efficient worldwide team to a larger structure will allow us to realize our model's full potential."
The acquisition is expected to close in the fourth quarter of this year. Financial terms of the all cash transaction have not been disclosed.
Posted on September 19, 2006 @ 10:06 am
Chemir Analytical Services has named
Lawrence (Bob) R. Lima III, Ph.D., vice president of Pharmaceutical Services. Dr. Lima directs the drug development services of Chemir’s Maryland Heights facility.
“The pharmaceutical and medical device industries have long utilized our analytical and research capabilities, and about half of our work is pharma-related,” says David Dowell, Ph.D., president of Chemir Analytical Services. “We welcome Bob’s depth of knowledge and experience in maintaining GMP compliance in FDA regulated studies as we further expand our service offerings to the pharma industry.”
Dr. Lima formerly directed analytical services at Analytical Biochemistry (ABC) Laboratories, as well as managed drug development projects for Allergan Pharmaceuticals and Procter & Gamble Pharmaceuticals.
Posted on September 18, 2006 @ 10:21 am
Pfizer and
TransTech Pharma have entered into a license agreement for the development and commercialization of several of TransTech's small and large molecule compounds. These compounds target the receptor for advanced glycation endproducts (RAGE) and have potential use in the treatment of Alzheimer's disease (AD).
Through the collaboration, Pfizer gains exclusive worldwide rights to develop and commercialize TransTech's portfolio of RAGE modulators including TTP488, a small-molecule compound that has completed a Phase IIa study in AD patients and is currently in a Phase II study in patients with diabetic nephropathy; and TTP4000, a large-molecule compound that is expected to enter Phase I trials this year.
Under the agreement, TransTech will receive upfront and near-term milestone payments of $155 million, with the potential for additional milestone payments for the successful development of multiple RAGE antagonists in several indications. TransTech will also receive royalties on worldwide sales of products. Pfizer will provide TransTech as much as $18 million during the research term to support continued expansion of the RAGE portfolio. The agreement is subject to clearance by U.S. Federal Trade Commission.
"This agreement is an important step in Pfizer's commitment to neurosciences research and the development of new medicines for patients whose lives are impacted by AD and other disorders," said Martin Mackay, Ph.D., Pfizer senior vice president Worldwide Research and Technology. "As a world leader in AD therapy, we understand the need for new treatment options for this debilitating disease which takes an enormous toll on our aging and elderly population."
"We are extremely pleased and excited to be partnering our RAGE platform with Pfizer," said Adnan M. M. Mjalli, Ph.D., founder, president and chief executive officer of TransTech Pharma. "We believe this transaction has the potential to be among the largest of its kind in recent years. Pfizer's deep commitment in multiple therapeutic areas coupled with their broad expertise and experience in the development and commercialization of new medicines, especially for the treatment of central nervous system diseases, were significant factors in our decision to go with Pfizer as the partner to advance our current portfolio of RAGE inhibitors."
Posted on September 18, 2006 @ 10:19 am
Akorn, Inc. has received a $3.5 million purchase order from the Department of Health and Human Services (HHS) to provide Ca-DTPA and Zn-DTPA. This order represents a partial exercise of a purchase option that was awarded to the company by HHS on December 30, 2005, for the acquisition of as much as an additional one million units of Ca-DTPA and Zn-DTPA by the U.S. Government.
The purchase order quantities are intended to provide countermeasures to protect the American military population in the event of a radiological or nuclear incident. Akorn expects to deliver the entire order quantity in the fourth quarter of this year.
Arthur S. Przybyl, president and chief executive officer stated, "This purchase order represents the first time that the Department of Health and Human Services has exercised its option to purchase additional quantities of Ca-DTPA and Zn-DTPA. We anticipate that additional purchase options will be exercised over the next several years for these two important antidotes."
Posted on September 18, 2006 @ 09:57 am
ArQule, Inc. has selected
Nextrials, Inc.'s clinical trial data collection and management product, Prism, for use in an ongoing Phase I/II trial. ArQule will deploy Prism to replace its paper-based data collection system in a dose-escalation study of the lead product from the company's Cancer Survival Protein (CSP) drug discovery platform.
"As a biotechnology company engaged in innovative small molecule cancer research, ArQule required a more efficient and cost-effective clinical trial data management system to help speed its drug development effort," said James Rogers, co-founder and chief executive officer of Nextrials. "Its latest study was already underway, yet Prism's flexibility enables it to seamlessly integrate into ArQule's existing processes and replace paper-based data collection without study disruption."
Nextrials' Prism is designed specifically for the pharma, biopharma, and medical device markets and combines all of the components of managing clinical trials research into a comprehensive, web-enabled system.
Posted on September 15, 2006 @ 10:06 am
Bioxel Pharma is manufacturing the first industrial scale cGMP batch of its key intermediate for docetaxel, the active ingredient in Taxotere, a chemotherapy drug marketed by Sanofi-Aventis.
"This achievement is significant for Bioxel as it demonstrates our ability to manufacture semi-synthetic taxanes using a high-efficiency patent-protected route that will allow us to meet the demands of leading pharmaceutical companies" said Pascal Delmas, president and chief executive officer of Bioxel Pharma. "Bioxel will be sampling its clients with docetaxel API during the fourth quarter of 2006 and we plan to complete the validation of our manufacturing process in 2007. We thus confirm our objective to broaden our product line and bring two new products to market next year: semi-synthetic paclitaxel and docetaxel. In addition to accessing new markets, docetaxel and semi-synthetic paclitaxel will allow Bioxel to maximize utilization of its taxane manufacturing platform and thus, to improve significantly its competitive position."
The first patents on docetaxel will expire at the end of 2007, making way for the development of generic Taxotere. Bioxel is actively pursuing commercial discussions with drug companies in an effort to ensure the efficient manufacturing and distribution of docetaxel.
Posted on September 15, 2006 @ 10:04 am
Schering AG and
AstraZeneca have formed an alliance to co-develop and jointly commercialize Schering's selective estrogen receptor downregulator (SERD). Under the terms of the agreement, the companies will develop the novel SERD with AZ leading the clinical development and Schering leading the non-clinical and process development as well as manufacturing activities. The companies will co-promote the product in the major territories. All development and commercialization costs and global profits will be shared. Financial terms were not disclosed.
"The development of agents that selectively down regulate the estrogen receptor is an exciting and important advance in the treatment of breast cancer. This novel SERD has the potential to offer a specific and targeted therapy approach for women with breast cancer," said Peter Zundorf, head of Schering Group's Oncology Global Business Unit. "We look forward to the collaboration with AZ. This collaboration reinforces our strong commitment to oncology. It is our intent to fully exploit this innovative compound and to maximize its value with joint forces."
John Patterson, executive vice president, development of AZ, said, "This agreement further strengthens AZ's pipeline and builds on our leading position in the anti-hormonal disease area. The novel SERD has the potential to deliver significant benefit to patients with estrogen-dependent cancers: the lead indication will be breast cancer. We are delighted to be working with Schering and will build upon our existing excellent relationship through collaboration in the area of anti-inflammatory research."
Posted on September 15, 2006 @ 09:51 am
Carlos Alonso has been named president of
Baxter Latin America, effective immediately. In his new role, he will oversee all Baxter businesses and operations in Latin America that include facilities in Argentina, Brazil, Central America, Chile, Colombia, Mexico and Venezuela. Mr. Alonso replaces
Marcelo A. Mosci, who will be leaving the company.
Since September 2004, Mr. Alonso has been general manager of Baxter operations in Brazil, Argentina and Chile. He has also held senior positions in the company's BioScience and Renal businesses, working in Latin America, Europe and Canada. Before joining the company, he was the country manager in Spain for Dentsply, a global dental products company.
"With experience spanning multiple Baxter businesses and geographies, Carlos has the ability to make an immediate positive impact on our business in Latin America," said John J. Greisch, corporate vice president and president of Baxter's international operations. "Through his strategic leadership ability and general management experience, I am confident we will continue to expand Baxter's presence in this important region."
Posted on September 14, 2006 @ 10:40 am
According to recent analysis from the
Tufts Center for the Study of Drug Development (Tufts CSDD), drug companies that develop and launch new products faster than their peers earn higher revenues and have lower development costs. Between 2000 and 2005, the fastest companies gained an average of $1.1 billion in incremental prescription revenue and saved an average of $30 million in development costs, as compared with the slowest companies, Tufts CSDD reported.
“Speed demon companies—the fastest drug developers—are consistently implementing efficient R&D practices across their portfolios,” said Ken Getz, senior research fellow at Tufts CSDD and co-author of the study. “These companies have far less development and regulatory time variability, kill projects sooner, and are better at setting resource priorities.”
The study evaluated 104 approved drugs for 29 companies and reported that, Bayer, Astra-Zeneca, Allergan, Boehringer-Ingelheim, and Merck are five of the fastest development companies. In the 2000-05 period, each was able to shorten its development and regulatory cycles by as much as 17 months, compared to average performing drug developers.
“Given the high direct cost of development and the substantial opportunity cost for a day of delay in reaching the market, speed and efficiency are central strategic objectives,” Mr. Getz noted. “This is especially important today with steadily rising R&D costs, lengthening development and regulatory approval times, ever more complex clinical trials, and stubbornly low success rates of drugs moving through clinical development.”
The study also found that: the fastest third of companies assessed reduced their median development speed by 20% and held regulatory cycle times flat at approximately 13 months; in each therapeutic area where they compete, the fast companies beat the median overall cycle time more than 83% of the time; fastest companies terminate 56% of discontinued projects in Phase I vs. 36% for slowest companies. Also, a one-day speed advantage typically saves $37,000 in development costs and nets an additional $1.1 million in daily prescription revenue for an average performing drug.
Posted on September 14, 2006 @ 10:37 am
Biogen Idec and
mondoBIOTECH AG have signed an exclusive collaboration and license agreement for Biogen Idec to develop, manufacture and commercialize Aviptadil, a clinical compound for the treatment of Pulmonary Arterial Hypertension (PAH).
Under terms of the agreement, mondoBIOTECH will receive a $7.5 million upfront payment and as much as $30 million in milestones for successful development and commercialization of Aviptadil in PAH in the U.S. and Europe, as well as royalty payments on commercial sales. Separately, Biogen intends to make a minority equity investment of $5 million in mondoBIOTECH during a foreseen initial public offering.
"This in-licensing opportunity supports our strategic initiative to expand into new therapeutic areas where we can leverage our global capabilities in serving specialized medical markets with high unmet need," said James C. Mullen, Biogen Idec's president and chief executive officer. "Aviptadil has the potential to be an important therapy in treating pulmonary arterial hypertension, an often deadly disease with few effective treatment options for patients. We look forward to developing Aviptadil for these patients and building on the strong work initiated by mondoBIOTECH."
"Biogen Idec is a premier biotechnology partner with a global structure, excellent clinical development and commercialization capabilities, and a strong record of accomplishments. We are excited to enter this collaboration which is a validation for our business model addressing fatal and rare lung diseases," said Fabio Cavalli, chief executive officer of mondoBIOTECH.
Under the agreement, Biogen will be responsible for the global manufacturing, clinical development, regulatory approval and commercialization of Aviptadil. Biogen plans to finalize the development plan for Aviptadil and begin additional clinical work in 2007.
Posted on September 14, 2006 @ 10:34 am
Genzyme Corp.'s interim results from a Phase II trial comparing Campath with Rebif for the treatment of multiple sclerosis show efficacy. The results are from a pre-specified analysis conducted after two years of treatment for 334 patients in the three-year trial.
As previously disclosed, dosing of Campath was suspended in September 2005 after three patients developed immune thrombocytopenic purpura (ITP), a condition causing a low platelet count as a result of an immune response directed against the platelets. At that time, most patients had received two cycles of therapy with Campath. Treatment with Rebif in the control arm has continued. The trial remains on clinical hold in the U.S., and the company is working with investigators and regulatory agencies to finish the study and ensure that the ITP risk is managed.
Analysis of the first co-primary endpoint showed that patients taking Campath at high and low doses experienced at least a 75% reduction in the risk for relapse after two years of follow up when compared to patients treated with Rebif. Analysis of the other co-primary endpoint showed that patients taking Campath at high and low doses experienced at least a 65% reduction in the risk for progression of clinically significant disability when compared to patients treated with Rebif. Results of additional secondary and tertiary efficacy endpoints, including MRI data, functional assessments, and quality of life measures, support these findings.
Genzyme has requested a meeting with the FDA to present these data and to address the next steps in the development of Campath. The company is moving forward with a Phase III study at the advice from the European Medicines Agency.
Posted on September 13, 2006 @ 10:42 am
MedImmune, Inc. broke ground on the expansion of the biologics manufacturing facility at its existing site in Frederick, MD. Synagis, a monoclonal antibody approved by the FDA to help prevent infectious disease, is currently produced at the site. The $250-million expansion is the first phase of a multi-phase construction project.
"This groundbreaking highlights MedImmune's leadership in the state's biotechnology industry, and its expertise in cell culture-based manufacturing," said Bernardus N.M. Machielse, Drs., senior vice president, operations. "Our decision to expand the Frederick site was facilitated in part by our cooperative relationship with state and local government."
The expansion will increase the company's cell culture manufacturing production capacity in preparation for future monoclonal antibodies that are currently in development, should they receive FDA approval. MedImmune recently received a $170-million, five-year contract from the U.S. Department of Health and Human Services (HHS) to develop cell culture-based seasonal and pandemic vaccines for which the Frederick facility will be the future production site. The phase one expansion is expected to be complete in late 2009.
Posted on September 13, 2006 @ 10:38 am
Tandem Labs has acquired PharmaKD, a Boston, MA-based division of Linden Technologies. Tandem will retain key personnel, intellectual property portfolios, proprietary informatics, scientific instruments, and 7,000-sq.-ft. of operational space from PharmaKD, which it will rename Tandem Labs - New England. Tandem will operate three facilities within the U.S.: Salt Lake City, New Jersey, and New England. Tandem's expanded services will include metabolite profiling, identification, and quantitation; biomarker discovery and screening; protein-binding assays; and discovery bioanalytical support services.
With the acquisition, Tandem Labs will obtain proprietary informatics that can reduce the difficulty, complexity, and time-consuming nature of developing and launching a drug to market, according to the company. DMDiscovery is an innovative drug metabolism technology that increases the productivity of drug metabolite identification and quantitation. MarkerScan is a biomarker discovery and screening process that efficiently identifies potential biomarkers that can be used to increase the understanding of disease, diagnosis, and predictive models as well as drug compound safety, efficacy, and side-effect profiles.
"As the costs increase yearly for developing and launching a new drug, Tandem Labs has vigorously investigated new technologies and services that will allow our clients to safely and cost-effectively bring new medicines to market," said Dr. Denis Lin, president and chief executive officer of Tandem Labs. "PharmaKD has strong intellectual property portfolios that improve pharmaceutical research productivity, reduce costs, and increase the success rate of drug candidates. These portfolios coupled with Tandem's long-standing, client-centric, and innovative bioanalytical services will provide our clients with a more complete laboratory menu and a higher likelihood of success when investigating new chemical entities."
Dr. Lily Li, president of PharmaKD and the newly appointed laboratory director of Tandem Labs-New England added, "We are extremely pleased to merge with an innovative and growing company such as Tandem Labs. We believe Tandem Labs has the services, customer focus, and dedicated sales force needed for future expansion in the competitive pharmaceutical-support industry."
As part of this acquisition, Tandem Labs has named
Dr. James Jersey as vice president and general manager of Tandem Labs - New England. Mr. Jersey has 15 years of business experience, particularly in the areas of marketing and business development, operational and technical management, and the launch of new business entities. From 1996 to 2004, Dr. Jersey founded and managed the rapid growth of a leading contract, fee-for-service bioanalytical services division within Primedica Corp., which was acquired by Charles River Laboratories in March 2001. While at Charles River Labs, he established and served as president of a new fee-for-service contract proteomic research services company in 2003. He also served as founder, chief technical officer, and senior scientist of the Bioanalytical Division within Triangle Laboratories as well as the principal investigator within the Department of Environmental Sciences and Engineering at the School of Public Health at the University of North Carolina at Chapel Hill
Posted on September 13, 2006 @ 10:36 am
Qualia Clinical Services has appointed
Azhar Kalim as vice president, business development and general manager of the company's North American operations. He is responsible for leading the business development activities of the company, which includes building client relationships, development of strategic partnerships and implementing strategies for North American growth.
Mr. Kalim has an extensive background in the clinical research industry, with more than 16 years of experience. He held pivotal roles, including scientific oversight as a principal scientist and as a member of the business development team managing a significant portfolio of major biopharmaceutical clients. Prior to joining Qualia, he served as vice president, business development at BA Research International.
"Azhar possesses a unique professional combination of skills: seasoned scientific knowledge along with refined sales experience," said Sohail Khattak, M.D., FRCP(C), president and chief executive officer, Qualia. "With his remarkable background developing client relationships and his strong management skills, he will contribute significantly to the success of Qualia."
Posted on September 12, 2006 @ 10:20 am
After the recommendation of outside Monitor Judge Frederick B. Lacey, Peter R. Dolan will vacate the position of chief executive officer at Bristol-Myers Squibb, effective immediately. The board has appointed James M. Cornelius, a director of the company since January 2005 and chairman emeritus of Guidant Corp., to act as interim chief executive officer.
Mr. Cornelius was chairman of the board and interim chief executive officer of Guidant from September 2004 through April 2006. He served as non-executive chairman of the Board from 2000 to 2005, and as senior executive and chairman from 1995 to 2000. Prior to Guidant, Mr. Cornelius was a director, a member of the executive committee and chief financial officer of Eli Lilly and Co.
"Jim's extensive experience in the healthcare arena will be critical in ensuring a smooth transition of leadership of this great company," said James D. Robinson III, chairman of the board, BMS. "I also want to express my deep appreciation and respect for Peter for his unyielding commitment to our company's mission, values and purpose, and for his many impressive achievements in developing and executing a successful strategy that has put BMS squarely on a path toward growth and leadership for the future."
Working with other members of the board, Mr. Robinson will chair a search committee to review internal and external candidates for the chief executive officer position. Mr. Dolan has agreed to act as an advisor to assist in the transition to new leadership.
Also, Richard K. Willard will leave the position of senior vice president and general counsel, effective immediately. Sandra Leung, vice president and corporate secretary, was appointed to act as interim general counsel. Former Federal Judge Louis J. Freeh, a director of the company and former general counsel of MBNA America, will serve as advisor to Ms. Leung. Mr. Willard has agreed to assist in the transition.
"We are grateful for Richard's contributions during an important time for BMS," said Mr. Freeh. He added, "I have worked closely with Sandy Leung, a 14-year veteran of the company, who is an outstanding attorney and enjoys the full confidence of our board and senior management."
At a previously scheduled meeting, the board received reports from the company's outside counsel on issues relating to the Plavix patent litigation with Apotex, Inc. and Apotex Corp. These reports were assessed at the request of the board regarding this matter. During the deliberations, the former Federal Judge Lacey, the Monitor under the company's deferred prosecution agreement with the office of the U.S. Attorney for the District of New Jersey, made a preliminary recommendation to the board to terminate the employment of both Mr. Dolan and Mr. Willard.
Judge Lacey's recommendation was the result of an inquiry by the Monitor and the U.S. Attorney into issues related to corporate governance in connection with the negotiation of a settlement agreement of the pending Plavix patent litigation. The Monitor and the U. S. Attorney did not find any violation of the deferred prosecution agreement or of any unlawful conduct by the company. The inquiry did not involve any matters related to the ongoing investigation by the Antitrust Division of the Department of Justice into the Plavix settlement agreement. The Monitor may make additional recommendations with respect to governance matters when he makes his final report on the inquiry.
Posted on September 12, 2006 @ 10:19 am
GlaxoSmithKline has settled the tax dispute with the Internal Revenue Service (IRS) for $3.1 billion, including federal, state and local taxes, interest and the benefit of tax relief on payments already made. The settlement covers a transfer pricing tax dispute dating from 1989 through 2005 that was to be decided by a trial scheduled for February 2007.
According to a company statement, the final payment fell within a $4.1 billion provision made by the company for tax liabilities. The company was exposed to a potential liability of $11.5 billion for 16 years of tax accounts between 1989 and 2005 that were disputed by the IRS.
In a statement, GSK said that the company has already earmarked enough money to cover the settlement and that the agreement is not expected to have any significant impact on the company's earnings. GSK also said it was confident in the "strength of its position" but decided that a settlement limiting financial exposure was in the best interest of its shareholders.
The dispute was centered on a disagreement between the IRS and HM Revenue and Customs in Britain, regarding Zantac profits. The disagreement between GSK and the IRS was about where the Zantac profit was earned and how much of the product’s value should be attributed to each jurisdiction. Developed and manufactured in the UK but widely sold in America, the U.S. tax bill depended on the transfer price (the value at which the drug was transferred to the group’s U.S. marketing subsidiaries).
Posted on September 12, 2006 @ 10:05 am
Cardinal Health has entered an agreement with
Trubion Pharmaceuticals, Inc. to research a new method to rapidly produce biopharmaceuticals that are smaller than traditional protein-based medicines.
Many traditional biopharmaceuticals are monoclonal antibodies (mAbs) made up of long-chain proteins that can sometimes fail to reach their targets due to their size. Trubion's proprietary Small Modular Immunopharmacetical (SMIP) drug design technology creates drug candidates of single-chain polypeptides, or short proteins, which are one-third to one-half the size of traditional therapeutic mAbs. As a result, SMIP proteins may help with tissue penetration in certain disease states, while retaining the beneficial therapeutic characteristics of larger molecules.
Cardinal will use its GPEx technology for rapid genetic engineering of stable cell lines that express the Trubion SMIP molecule in sufficient quantities to support Trubion's clinical trial needs. Financial terms of the agreement were not disclosed.
"The biopharmaceutical industry is at a critical time when complex molecules are being developed on an unprecedented scale for a wide array of disease states, many of which are underserved by existing drugs," said Paul Weiss, Ph.D., president of Cardinal Health's biopharmaceutical development services center. "While GPEx has been used to engineer cell lines that produce more 'traditional' biopharmaceuticals, this agreement calls for us to engineer cell lines that express an engineered novel SMIP molecule. We believe GPEx is very well suited for these type of products, given its inherent flexibility for cell line transduction."
Posted on September 11, 2006 @ 10:29 am
Codexis, Inc. has achieved a significant development milestone under a research agreement with
Schering-Plough to rapidly generate a novel biocatalytic process to produce a key intermediate for an undisclosed human therapeutics compound. This program is based on Codexis' MolecularBreeding pharmaceutical process re-engineering platform, and is expected to reduce manufacturing costs and environmental waste in the final production process.
"The agreement with Schering-Plough was announced in March, and Codexis has quickly met the initial development milestone," said Alan Shaw, Ph.D., Codexis president and chief executive officer. "We are very pleased with this substantial progress in our collaboration and look forward to continuing to demonstrate the value of our technology to this important partner. An increasing number of worldwide pharmaceutical partners are recognizing the Codexis competitive advantage in developing rapid, efficient clinical-scale manufacturing production processes."
Posted on September 11, 2006 @ 10:27 am
Atrium Biotechnologies, Inc. has acquired the assets of London, Ontario-based
Douglas Laboratories Canada (DL Canada). DL Canada has been marketing Douglas Laboratories products in Canada since 2000 and has current annual revenues of approximately $5 million. DL Canada's current management and staff are staying on to ensure the successful integration of the two companies.
"This acquisition provides Atrium with a platform to develop the Canadian healthcare professional market not only for the Douglas Laboratories brand but also for the Pure Encapsulations brand which is not currently being sold in Canada. This acquisition further reinforces our current leadership position in North America and marks another step in our strategy to control access to markets and build solid organic growth for our brands," said Richard Bordeleau, president of Atrium's Health & Nutrition Division.
"Our company has been focused on growing the Douglas Laboratories' business in Canada. We are convinced that under Atrium's leadership we will accelerate our growth and we are very optimistic about the future especially with the synergies created by combining our companies," stated Dr. Victoria Coleman-Kay, president of DL Canada.
Posted on September 11, 2006 @ 10:03 am
Cipher Pharmaceuticals' preliminary results from the 02.05 Phase III study of CIP-Tramadol ER, an extended-release capsule formulation of the pain medication tramadol, did not achieve a statistically significant effect relative to placebo. While all three active treatment groups in the study demonstrated a reduction in pain from baseline, the 02.05 efficacy results did not achieve statistical significance with respect to the primary endpoint. A higher than anticipated placebo effect was observed in the control arm.
Cipher's NDA for CIP-Tramadol ER was accepted for review by the FDA and in January 2006, Cipher was advised by the FDA that its existing clinical data package met the requirements to file an NDA. The NDA contains data from six pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data). Data analysis on the trial is continuing and the final report will be provided to the FDA once it is available.
The 02.05 study enrolled 860 patients in a double-blind randomized fixed-dose trial designed to compare efficacy and safety of CIP-Tramadol ER with placebo. The primary efficacy endpoint of the study was WOMAC pain intensity. The trial was conducted over a 12-week treatment period in patients with moderate to moderately severe chronic pain from osteoarthritis of the knee or hip. Patients were randomly assigned to one of four arms, a placebo arm and three active arms consisting of a 100 mg, 200 mg, or 300 mg dose of CIP-Tramadol ER.
Posted on September 8, 2006 @ 10:19 am
Applikon Biotechnology and
Finesse, LLC have signed a licensing agreement for the TruBio O/S Bioreactor Control Operating System, a digitally enabled, fully configurable open process control system developed for the life science industry. This agreement will enable Applikon bioreactors with a Delta V controls solution from Emerson Process Management, as well as an optional embedded PI Enterprise Server with PI Historian, PI Datalink, PI Process Book, PI Batch and OPC-HDA for data management.
Applikon's bioreactor design and manufacturing expertise, together with Finesse's bioprocess control and automation proficiency, will create a new bioreactor product family that operates under a unified, plant-wide control system platform. TruBIO O/S will be offered on Applikon's i-ControlXL controller and on TruLOGIC controller for migrations of Applikon 1010 and 1030 controllers.
"We look forward to an enduring and mutually beneficial partnership with Applikon," stated Barbara Paldus, chief executive officer of Finesse. "The combination of TruBIO O/S with Applikon's broad bioreactor/fermentor offering, including single-use Appliflex systems, vessels ranging from 1L glass to 300L stainless steel, as well as micro bioreactors, will provide the global life sciences market with a consistent solution set that is fully scalable from R&D to Process Development and into Manufacturing."
Applikon president John Chory stated, "The collaboration with Finesse will now enable Applikon bioreactor control systems to also integrate a DeltaV solution into Applikon's i-ControlXL thus offering complete controls solutions to its customers regardless of the technology platform they have or choose to adopt. The expertise that Finesse offers with DeltaV integration provides an added value permitting Applikon to offer customers a reliable and prompt solution to their comprehensive controls and implementation requirements."
Posted on September 8, 2006 @ 10:13 am
Parexel Consulting has expanded its risk management and strategic compliance expertise with the appointment of
Anthony C. Warchut, formerly an investigator in the FDA Pharmaceutical Inspectorate. Mr. Warchut brings 29 years of FDA pharmaceutical inspection experience to the company, and joins a global network of consultants dedicated to addressing the full range of risk management challenges facing companies.
Mr. Warchut has extensive experience with complex products, technologies and advanced pharmaceutical manufacturing processes. The Pharmaceutical Inspectorate was established as a result of the FDA's "Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach," a major global initiative to ensure the quality of drug products. His experience also includes inspections of sponsor/monitors, clinical investigators, bioequivalence laboratories and non-clinical laboratories, as well as inspections involving the FDA's Application Integrity Policy.
"Tony is the first of the Pharmaceutical Inspectorate cadre to leave the FDA and join industry and we are proud that he selected PAREXEL Consulting," said Gadi Saarony, general manager of the Strategic Compliance and Operational Excellence Practice at PAREXEL Consulting. "Tony brings the deep expertise our clients need to help assure product quality and safety and to proactively identify and manage risks associated with biopharmaceutical product and medical device development."
Posted on September 8, 2006 @ 10:11 am
Eisai Co., Ltd. and Eisai, Inc. have signed a $205 million product acquisition agreement with
Ligand Pharmaceuticals in which Eisai will obtain exclusive global rights for Ontak, Targretin capsules, Targretin gel 1% and Panretin gel 0.1%. Also, Eisai, Inc. will offer certain Ligand personnel, employment.
The acquisition of the four oncology-related products are part of the company's strategic business plan to help establish Eisai's global oncology business.
"We believe that Eisai has a promising future in oncology and that the acquisition of these products, as well as the valuable expertise and experience of those Ligand personnel to whom employment will be offered, is a well-planned approach to market entry," said Lonnel Coats, president and chief operating officer, Eisai, Inc. "In addition, our strategic focus in oncology helps fulfill our human health care mission to satisfy unmet medical needs and increase benefits to patients and their families."
The transaction is subject to government approvals and is expected to close before the end of the year.
Posted on September 7, 2006 @ 10:27 am
Cardinal Health, Inc. and Ovation Pharmaceuticals, Inc. received an approval letter from the FDA for Cardinal Health’s new sterile facility in North Raleigh, NC to manufacture Panhemati, an Ovation biologic therapy used to treat acute porphyria, a rare genetic disorder. The new facility currently has 82 employees and is expected to grow to 200 jobs for the Raleigh area when it reaches full capacity.
Jeffrey S. Aronin, president and chief executive officer of Ovation Pharmaceuticals said, “We felt it was important to invest in sustaining ongoing supply of this life-saving medication. This new, state-of-the-art manufacturing facility will ensure that patients suffering from this rare enzymatic disease get the treatment they need. With Ovation’s commitment to this underserved patient population and Cardinal Health’s sterile manufacturing expertise, we are well positioned to provide patients with an uninterrupted supply of Panhematin well into the future.”
“Ovation is leveraging multiple capabilities within Cardinal Health to simplify the manufacturing and packaging processes and get Panhematin into the hands of those who need it,” said Shawn Gallagher, vice president and general manager of Cardinal Health’s North Raleigh facility. “Panhematin is the first commercial drug to be manufactured at the new facility in North Raleigh, and this helps prepare the site for additional commercialization of products. The facility has capacity to support production of a range of other biopharmaceutical products.”
Posted on September 7, 2006 @ 10:22 am
Abbott has simultaneously submitted an sBLA with the FDA and a Type II Variation to the EMEA seeking approval to market Humira as a treatment for moderate-to-severe Crohn's disease. Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe combined.
The filings are based on the results of three randomized, double- blind, placebo-controlled, multi-center trials of Humira evaluating efficacy and safety in a range of moderate-to-severe Crohn's disease patients, from those who were naive to anti-TNF therapy to patients who had previously lost response or were unable to tolerate infliximab. In these trials, Humira demonstrated statistical significance in inducing and maintaining clinical remission.
Posted on September 7, 2006 @ 10:14 am
Peter Nicklin has been named corporate vice president of
Baxter World Trade Corp. and president of Baxter Europe, effective October 1, 2006. Mr. Nicklin will be responsible for the company's European operations, which had revenues totaling more than $3 billion in 2005. He will be based in Zurich, Switzerland, reporting to
John J. Greisch, corporate vice president and president of Baxter's international operations.
"With his significant international experience and outstanding track record within the pharmaceutical and medical device industries, Peter is ideally suited to lead our European organization," said Mr. Greisch. "His talents in developing businesses and people will help drive continued growth for Baxter across Europe."
Mr. Nicklin joins the company from Bayer AG where he served as president of the Animal Health Division, board member of Bayer HealthCare AG and regional head of Bayer HealthCare's business in Asia Pacific. Prior to joining Bayer, he was responsible for the Western and Central European pharmaceutical businesses of Novartis AG. He also held several general and executive management positions for Bristol-Myers Squibb Co. in Europe and Asia.
Posted on September 6, 2006 @ 09:51 am
Pyramid Laboratories, Inc. has completed the cGMP manufacturing of
Endovasc's Liprostin for the company's proposed Phase IIIa trial for patients suffering from Intermittent Claudication. Endovasc's Liprostin is a liposome-encapsulated form of prostaglandin E-1 (PGE-1), which is known to be a potent vasodilator and platelet inhibitor as well as an anti-inflammatory and anti-thrombotic agent. In February 2006, Endovasc submitted its protocol for the trial of Liprostin for treatment of intermittent claudication, a symptom of Peripheral Arterial Disease, to the FDA. Intermittent claudication causes a cramping sensation in the legs that is present during exercise or walking and occurs as a result of decreased blood and oxygen supply. If left untreated, clots may form and lead to leg ulcers, gangrene and ultimately amputation.
"Pyramid Laboratories is an excellent partner who has successfully manufactured Liprostin for us throughout the earlier phases of our FDA trials. We continue to focus our efforts on the selection of investigators and clinical sites," said Diane Dottavio, Ph.D., Endovasc's chairman and chief executive officer.
Posted on September 6, 2006 @ 09:46 am
Andrea Chopek has been appointed director of business development and sales for
Emerson Resources. Ms. Chopek will be responsible for the development and execution of strategies related to marketing, sales, advertising, and customer service, while developing creative business opportunities and allegiances. She will serve together on the management team with the vice presidents of scientific affairs and administrative services, and the managers of quality assurance, contract services and manufacturing.
Ms. Chopek served as an officer in the U.S. Navy for four years, actively deployed to both the Middle and Far East. During this time, she was responsible for developing strategic supply systems, leading ongoing operations, increasing readiness, and renegotiating several contracts that resulted in significant cost savings. Subsequently, she has held positions as director of marketing, sales and product planning, healthcare sales consultant and pharmaceutical account manager.
During her tenure at Pfizer, Ms. Chopek was consistently recognized as a top performer and awarded numerous district, regional and national sales awards. In her most recent position at CHR Hansen, she was responsible for overseeing sales, business development, key account management, contract negotiations, and providing cross-functional team direction and leadership.
"We are very excited that Andrea is joining our team," said Walter Strathy, president and chief operating officer. "Andrea's addition to our organization is a significant step toward increasing our impact on the industry."
Posted on September 6, 2006 @ 09:45 am
Pharm-Olam International, Ltd. is continuing expansion of its Indian operations. The company says that its clinical staff has tripled since 2005 to meet sponsor demand for conducting trials in the country.
"Pharm-Olam is approaching our fourth year of helping sponsors conduct trials in India and we are excited about the potential for continued growth. India is a logical choice for larger studies of any indication due to rapid rates of recruitment, and lower investigator fees and treatment costs," said Iain Gordon, director of global business development. "India has a very high number of new oncology and infectious disease patients every year, resulting in greatly increased recruitment rates for treatment-naive patients." The company began operations in India opening an office in Bangalore in January 2003.
Posted on September 5, 2006 @ 10:45 am
As part of a strategic initiative,
Auxilium Pharmaceuticals has concluded its co-promotion partnership with
Oscient Pharmaceuticals for Testim 1% testosterone gel and has leased a biologics manufacturing facility for the commercial development of its injectable enzyme product AA4500. Also, to support the growth of Testim, the company initiated an expansion of its sales force.
"Because of AA4500's potential to be the first, non-surgical, biologic treatment option for patients with several life-impacting conditions and the key role we expect AA4500 to play in our future growth, we concluded that controlling the majority of the manufacturing of the active ingredient in AA4500 will be a strategic advantage," said Armando Anido, Auxilium's chief executive officer. "As the manufacturing facility already contains most of the equipment necessary to produce AA4500, we believe that the required modifications can be completed in time to include the facility in our initial BLA for the treatment of Dupuytren's Contracture in 2007."
Auxilium is developing AA4500 for the treatment of Dupuytren's Contracture, Peyronie's Disease and Frozen Shoulder Syndrome. The company plans to initiate a final Phase III trial for the treatment of Dupuytren's Contracture and a Phase IIb dose optimization study for the treatment of Peyronie's Disease later this year.
The biologics facility contains fermentation and purification equipment for the production of AA4500, laboratories for in-process and final product release testing, as well as development laboratories that Auxilium believes will be useful in R&D activities related to the life cycle management of AA4500 and other potential product candidates.
As part of the strategic initiative to control the commercial development of Testim, the company is increasing its sales force from the current 94 territories to approximately 150 territories and has mutually agreed with Oscient Pharmaceuticals to terminate the co-promotion partnership for Testim effective August 31, 2006. Auxilium will pay Oscient $1.8 million for the early termination.
"We believe that expanding our own sales force with employees consistently dedicated to Testim throughout the entire year will allow us to fully control our promotional efforts and build upon our excellent track record of growth for this product," Mr. Anido commented.
Posted on September 5, 2006 @ 10:43 am
GlaxoSmithKline and
Adolor Corp. achieved top-line results from two Phase III registration studies (012 and 013) of alvimopan (Entereg/Entrareg) for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic non-cancer pain. Study 012 achieved statistical significance for the primary endpoint -- the proportion of patients who had a weekly average of three or more spontaneous bowel movements (SBM) defined as bowel movements with no laxative in the previous 24 hours and an increase from baseline of one or more SBMs a week over the 12-week treatment period. In patients treated with alvimopan 0.5 mg twice daily, 72% met the primary endpoint compared with 48% of patients receiving placebo. In patients treated with alvimopan 0.5 mg once daily, 61% met the primary endpoint compared with 48% of patients receiving placebo.
The 013 study had less statistical significance. Of the patients treated with alvimopan 0.5 mg twice and once daily, 63% met the primary endpoint compared with 56% of patients receiving placebo. As in the 012 study the weekly change from baseline in SBM frequency was numerically greater in both groups of alvimopan treated patients averaging 3.1 and 3.2 SBMs per week respectively, compared with 2.2 SBMs per week for those treated with placebo. These changes, evident by the first week of treatment, were sustained throughout the 12-week treatment period and returned to baseline following discontinuation of treatment.
Alvimopan was generally well tolerated in these studies. Adverse events (AEs) affecting the gastrointestinal (GI) tract were the most common in both studies occurring in 24-33% of alvimopan-treated patients, compared with 22% on placebo.
Posted on September 5, 2006 @ 10:42 am
MAP Pharmaceuticals has initiated patient dosing in a Phase II trial evaluating MAP0004 for the treatment of acute migraine headaches. MAP0004 is an inhaled drug formulation of dihydroergotamine mesylate (DHE) administered with the company's Tempo Inhaler. The therapy is intended to offer fast onset of action similar to an IV infusion, but without the need for an injection in a hospital or doctor's office setting.
The Phase II trial will be conducted in as many as 10 sites in the U.S. as a randomized, double-blind, placebo-controlled study in approximately 100 migraine patients. The efficacy of three doses of MAP0004 will be assessed, with the primary endpoint for the trial being pain relief at two hours. Additional endpoints include relief from nausea, phonophobia and photophobia. Safety evaluations will be made throughout the trial period.
Posted on September 1, 2006 @ 09:05 am
Invitrogen Corp. has entered into a definitive merger agreement under which Invitrogen will acquire New Jersey-based
Sentigen in a cash transaction of approximately $25.9 million for all shares currently issued and outstanding.
Sentigen's Tango Assay System and division arrested Assay Ready Cells will bolster Invitrogen's position in assay development by providing a novel approach to screen G-protein coupled receptors (GPCR) and other key drug target classes, as well as providing a methodology to convert live cell assays into ready-to-use consumable products. Sentigen will become a part of Invitrogen's Discovery Sciences Business based in Madison, WI.
"Adding Sentigen's capabilities to our drug discovery platform gives researchers an even broader array of solutions for GPCR screening, profiling and other cellular studies," said Nick Ecos, vice president and general manager of Invitrogen's Discovery Sciences business.
"The synergy created by combining Invitrogen's cell and molecular biology products with Sentigen's cell-based technologies and custom services enhances our strategic commitment to scientists engaged in cell-based drug discovery by offering our clients comprehensive solutions and support," said Tom Livelli, Sentigen's president and chief executive officer.
The transaction is subject to customary closing conditions, including the approval of Sentigen's stockholders, and is expected to close in the fourth quarter of this year.
Posted on September 1, 2006 @ 08:55 am
MDS Pharma Services has appointed two industry experts as part of a growth strategy to sharpen the focus on new business opportunities in drug and biopharmaceutical development.
Dr. Claudio Carini, a globally recognized leader for his work in developing and applying biomarkers to indicate the risk, presence and progression of diseases, has been named vice president of translational medicine.
Suzanne Sensabaugh, a global leader recognized for her regulatory expertise in helping clients in the development of biopharmaceuticals, has been named vice president of biopharmaceutical development
Dr. Carini will manage and direct The Biomarker Alliance, which provides one-stop shopping for biomarker service providers to join together to design and execute a wide range of biomarker discovery and development programs. Dr. Carini has more than 25 years experience as a physician and scientist in industry and academia. He most recently served as vice president and global head of biomarkers at Roche Pharma and is well known for his development of several products to provide anti-infective and anti-inflammatory relief for patients.
Ms. Sensabaugh will be responsible for leading the consulting group responsible for development of biopharmaceuticals. Most recently she served as vice president for U.S. Regulatory Affairs and senior director for global biogenerics at Teva Pharmaceuticals. She has more than 10 years of experience at the FDA Center for Biologics Evaluation.
Posted on September 1, 2006 @ 08:50 am
Apotex, Inc. has selected
Sparta Systems, Inc.'s TrackWise as its global solution to capture and track all regulatory information required for new products and product lifecycle management. TrackWise is a web-based software platform that allows organizations to implement a secure and expandable tracking solution to manage regulatory compliance data, activities and work processes.
Apotex produces more than 300 generic pharmaceuticals in over 4,000 dosages. The TrackWise system will provide Apotex with an electronic, integrated solution to manage Product Life Cycle Management (PLCM) activities required to meet expanding global market needs. The system will be used to manage submissions, amendments, change notices, periodic safety reports, commitments and other regulatory activities.
"The vision of this system is to create an efficient, cost effective, global solution to track all required regulatory information pertaining to new products and product lifecycle management," stated Michael Davidson, chief information officer for Apotex. "Apotex selected TrackWise because it meets our functional requirements, and it provides our organization with a scalable and configurable web-based architecture, which has the ability to adapt and grow as our company's needs evolve."
"Sparta is pleased to be awarded this contract, and looks forward to a long lasting partnership with Apotex" stated Steve Cagle, vice president of marketing and product development at Sparta Systems, Inc. "Improving regulatory affairs tracking systems enables companies to be more efficient and effective in their product approval process. We expect TrackWise to help Apotex improve its time to market and decrease costs associated with meeting ever-increasing regulatory compliance requirements."
August 2006
Posted on August 31, 2006 @ 09:56 am
Genzyme Corp. has proposed to acquire
AnorMED, Inc. of Vancouver, British Columbia in an all cash transaction valued at approximately $380 million. AnorMED's leading late-stage product candidate, Mozobil, in development for hematopoietic stem cell transplantation (HSCT) could improve the viability of HSCT and enlarge the pool of patients for whom transplantation is an option. Enrollment is complete in a Phase III trial for Mozobil in multiple myeloma, and a second Phase III trial in non-Hodgkin's lymphoma is expected to conclude in late-2006. Mozobil has been granted special protocol assessment and orphan drug status in the U.S. and the EU.
"We believe Mozobil represents an important therapeutic advance in the field of stem cell transplantation, and Genzyme is uniquely positioned to ensure that it reaches its full global potential," said Henri A. Termeer, chairman and chief executive officer of Genzyme. "Our clinical/regulatory infrastructure will allow us to complete development and registration of Mozobil without delay and at a considerably reduced execution risk; the commercial infrastructure we have developed to support our transplant business unit will allow Mozobil to be made available with reduced incremental investment and delay, and our strong financial position eliminates any capital market and dilution risk."
"We are in a position to offer AnorMED shareholders full value now for their pioneering efforts to develop Mozobil and enable them to realize an excellent return on their investment," said Mr. Termeer. "The addition of Mozobil will broaden Genzyme's transplant business by increasing its presence in hematological transplantation, a large and growing market. Our established transplant and oncology businesses provide a solid platform to launch Mozobil's growth and drive its adoption in stem cell transplantation procedures throughout the world."
Mozobil has been shown to rapidly increase the number of stem cells in circulation in the blood, an important step in preparing a patient for a stem cell transplant. Approximately 45,000 stem cell transplants are performed each year in the U.S. and Europe for multiple myeloma, non-Hodgkin's lymphoma, and other conditions.
Genzyme has been in discussions with AnorMED regarding Mozobil since October 2005, including an acquisition proposal in April 2006.
Posted on August 31, 2006 @ 09:53 am
Akorn, Inc. has signed a commercial manufacturing supply agreement with
GeneraMedix, Inc. to manufacture injectable products in finished dosage form for GeneraMedix. Under the agreement, GeneraMedix will market these products in the GeneraMedix label. The agreement includes products currently available from Akorn, as well as select injectable products from the Akorn internal product development pipeline.
Arthur S. Przybyl, president and chief executive officer of Akorn stated, "We are excited to enter into this strategic product supply partnership with GeneraMedix. This partnership will allow us to expand our existing market share and increase our contract sales revenues. We believe that GeneraMedix and their executive management team have the experience and infrastructure to successfully market these generic products to the hospital and specialty pharmaceutical markets. We look forward to a long-standing and successful relationship."
Ronald F. Quadrel, president and chief executive officer of GeneraMedix stated, "We are very pleased to enter into this strategic relationship with Akorn as we continue to build our injectable product portfolio. The addition of these products reinforces our long term commitment to provide a broad range of generic injectable products to hospitals, surgery centers and clinics."
Posted on August 31, 2006 @ 09:46 am
Sanofi-Aventis U.S. has exercised its right to extend the term of its research collaboration with
ImmunoGen, Inc. and will now provide research support funding through August 31, 2008. Also, effective September 1, 2006, ImmunoGen will no longer be obligated to present new targets for antibody-based anticancer therapeutics to Sanofi-Aventis, enabling the company to use such targets in the development of its own proprietary products.
"We're pleased that our relationship with Sanofi-Aventis will move to its next stage in an orderly and logical fashion and with the opportunity for significant return that this collaboration provides for ImmunoGen going forward," commented Mitchel Sayare, ImmunoGen chairman and chief executive officer. "ImmunoGen will receive research support funding from Sanofi-Aventis through August 2008 and we're also free to use new targets that we identify for our own product programs. We continue to be entitled to receive milestone payments, manufacturing payments and royalties for each compound in the collaboration and to have certain co-promotion rights. After August 2008, we'll also have the potential for compensation from Sanofi-Aventis for each license they take to use our technology with antibodies to targets that weren't part of our research collaboration."
After August 2008, Sanofi-Aventis will need to license the right to use ImmunoGen's maytansinoid TAP technology with antibodies to targets that were not part of the research collaboration. The two companies have agreed to negotiate a multi-target agreement to provide Sanofi-Aventis with access to ImmunoGen's maytansinoid TAP technology for antibody targets.
Posted on August 30, 2006 @ 10:36 am
Roche has discontinued its involvement with
PDL BioPharma in the development of daclizumab in asthma, which the companies had been co-developing since 2004. The decision, following a portfolio review at Roche, has no effect on the companies' ongoing collaboration to co-develop daclizumab in transplant maintenance, and the companies intend to proceed with planned Phase II studies for the transplant indication during 2007.
As a result, PDL now holds exclusive development and commercial rights to daclizumab in asthma. In a separate collaboration, Biogen Idec and PDL are developing daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.
"We are evaluating opportunities to establish a new collaboration and would need to partner this program in order to further develop daclizumab in asthma," said Mark McDade, chief executive officer, PDL BioPharma. "In the meantime, we will redouble our efforts to focus daclizumab development in MS and chronic transplant."
Posted on August 30, 2006 @ 10:35 am
Schering-Plough Corp. has reached an agreement with the U.S. Attorney's Office for the District of Massachusetts and the U.S. Department of Justice to settle the investigation involving the company's sales, marketing and clinical trial practices and programs.
The agreement resolves the investigation, which began prior to the arrival of the current management team. The agreement provides for a settlement of $435 million, subject to court approval. Under the agreement, Schering Sales Corp., a subsidiary of Schering-Plough, will plead guilty to one count of conspiracy to make false statements to the government and pay a criminal fine of $180 million, and Schering-Plough will pay $255 million to resolve civil aspects of the investigation.
In connection with the settlement, Schering-Plough will also sign an addendum to an existing corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). The addendum will not affect the company's ongoing business with any customers, including the federal government.
Posted on August 30, 2006 @ 10:32 am
Robert L. Kirkman, M.D. has been named president and chief executive officer of
Biomira and was also elected to the board of directors. The company has named
Christopher Henney, Ph.D. chairman of the board.
Dr. Kirkman was formerly acting president and chief executive officer of Xcyte Therapies, Inc of Seattle, WA, which concluded a merger with Cyclacel Pharmaceuticals, Inc., in March 2006. From 2004-2005, Dr. Kirkman was chief business officer and vice president at Xcyte and from 1998 to 2003 he was vice president, business development and corporate communications at Protein Design Labs.
Dr. Henney joined the board of directors in March 2005 and is the co-founder of three major publicly traded U.S. biotech companies, Immunex, ICOS and Dendreon. Dr. Henney was chairman and chief executive officer of Dendreon from 1995 to 2004. He is chairman of SGX Pharmaceuticals and vice-chairman of Cyclacel Pharmaceuticals. Mr. Eric Baker, the outgoing chairman of the board, will remain on the board.
The company has also reappointed
Robert Blair to the board of directors. "We are glad that Bob Blair has agreed to give us the benefit of his long experience as a prior member of Biomira's Board," said Dr. Henney.
Posted on August 29, 2006 @ 09:21 am
Purdue Pharma and
Teva Pharmaceuticals USA, Inc. have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin tablets. Under the terms of the settlement agreement, Teva will cease selling its infringing oxycodone products at a future date and Purdue Pharma will not pursue damages against Teva for past infringement. The settlement agreement is subject to certain contingencies, including review by the U.S. antitrust agencies and the U.S. District Court for the Southern District of NY.
"We are pleased that Teva will respect our invention of an important medicine. I believe we would have prevailed in our lawsuit and the court eventually would have ordered Teva to stop selling its infringing product. Because of today's agreement, we no longer have to wait for a trial, and possible appeals, in order to secure the result provided in the agreement. We have avoided the risks, uncertainty and costs of continued litigation," said Michael Friedman, president and chief executive officer of Purdue Pharma, in announcing the end of the lawsuit. "Our first commitment is and always will be to serve both physicians and patients with innovative prescription and non-prescription products. In service of that commitment, we will continue to protect our important inventions against all infringers," Mr. Friedman concluded.
Purdue Pharma has filed infringement actions to protect its OxyContin patents against other companies. On February 1, 2006, the U.S. Court of Appeals for the Federal Circuit ruled the Purdue patents to have been infringed by extended-release oxycodone products sold by
Endo Pharmaceuticals.
Posted on August 29, 2006 @ 09:16 am
Althea Technologies has been awarded a cGMP manufacturing contract to produce a DNA-based HIV-1 vaccine. The contract, awarded by
Advanced BioScience Laboratories, Inc. (ABL), is under a master agreement with the National Institutes of Health (NIH) and funded by the National Institute of Allergy and Infectious Diseases (NIAID). The $911,549 in funding for Althea's production of the vaccine is provided in its entirety by the NIAID and NIH. The contract will support Althea's efforts for plasmid DNA process development, vaccine production, purification, and regulatory documentation.
The company contends that plasmid DNA vaccines are an attractive alternative to traditional production methods because the vaccines produced are noninfectious, and the manufacturing processes are straightforward and economical. The other significant benefit of this production method is a shelf-life appropriate for public health programs.
Under the NIH multi-year contract managed by ABL for preclinical development and production of this vaccine, Althea will be supporting a larger vaccine development program which is part of an international effort to combat AIDS. This NIAID funded effort is in conjunction with the South African AIDS Vaccine Initiative (SAAVI).
Dr. Magda Marquet, Althea's co-president and co-chief executive officer, remarked, "We are delighted that Althea was chosen by Advanced BioScience Laboratories and the National Institutes of Health to produce this new type of DNA HIV-1 vaccine. AIDS is a devastating world pandemic and it is our hope that utilizing this new innovative technology will make a positive difference in this fight."
Posted on August 29, 2006 @ 09:08 am
HemaCare Corp. has acquired privately owned
Teragenix Corp. for $4.8 million. Teragenix, which had 2005 sales of $5 million and pre-tax profit of about $600,000, is a provider of human biological samples, quality control products and clinical trial management services. The acquisition represents a significant step in furthering HemaCare's strategy to expand product and service offerings for biotechnology, pharmaceutical and other research-focused organizations, according to a company statement.
Teragenix was acquired in exchange for a combination of cash, notes, assumed debt and HemaCare common stock valued at $4.8 million. Approximately $2.3 million in cash and stock will be paid immediately, subject to working capital adjustments, plus $700,000 in notes and assumed debt, and $1.8 million will be paid over time as part of a potential earn-out with specific earnings targets. Earn-out payments to the owners of Teragenix, both of whom are members of the management team and who will continue to operate the business, are due in installments based on financial results through 2008.
"We are delighted that Teragenix and its operating team will be joining HemaCare," stated Judi Irving, HemaCare's president and chief executive officer. "Teragenix has established a world wide network of clinical partners that provide it with a unique ability to collect and document biological samples essential for biomedical research. The research segment is a logical extension of our core blood products business and our strategic intention is to continue growing research sales both organically and through acquisition."
Posted on August 28, 2006 @ 02:38 pm
Mylan Laboratories has announced plans to
acquire Matrix Laboratories Ltd. for approximately $736 million. Under the terms of the transaction, Mylan will purchase 51.5% of Matrix's shares outstanding under an agreement with certain selling shareholders and will make an "open offer" to Matrix's remaining shareholders to acquire as much as 20% more of Matrix's shares outstanding. Matrix will remain a publicly traded company in India and will continue to operate on an independent basis, according to Mylan
Robert J. Coury, Mylan's vice chairman and chief executive officer, commented, "This is an extremely complementary transaction that accomplishes a number of Mylan's key objectives. Mylan is executing on its commitment to establish a global platform and expand its dosage forms and therapeutic categories. Additionally, this acquisition deepens Mylan's vertical integration and enhances its supply chain capabilities. The transaction will allow Mylan and Matrix to strengthen and expand their core businesses and competencies, while creating significant opportunities for global expansion and growth."
He added, "In addition to bringing substantial tangible benefits in the form of their world-class manufacturing capabilities and product portfolios, Matrix and its European subsidiary, Docpharma, have demonstrated a deep understanding of their respective regions and markets. We are very excited about the transaction and expect, based on our time together thus far, a smooth and effective integration. We have found that Matrix and Docpharma have cultures and values that are extremely consistent to our own at Mylan."
Mylan and Matrix together will have approximately 5,100 employees in 10 countries. Matrix will provide Mylan with a significant presence in important emerging pharmaceutical markets, including India, China, and Africa, as well as a European footprint and distribution network through Matrix's Docpharma subsidiary. By combining Matrix's API and drug development business with Mylan's expertise in finished dosage forms FDFs, Mylan will be able to capture incremental pieces of the value chain through backward vertical integration.
Posted on August 28, 2006 @ 02:32 pm
MedImmune and
Infinity Pharmaceuticals have entered into an agreement to jointly develop and commercialize novel small molecule cancer drugs targeting Heat Shock Protein 90 (Hsp90) and the Hedgehog cell-signaling pathway. In preclinical studies, Hsp90 and the Hedgehog pathway appear to be implicated in the growth and survival of a broad range of blood-related and solid tumor types. IPI-504, the most advanced of the drug candidates included in the agreement, is an Hsp90 inhibitor that has thus far been studied in two disease-focused Phase I trials.
MedImmune and Infinity will share equally all costs and profits from the development and commercialization of any future products. MedImmune will provide Infinity a one-time upfront payment of $70 million for co-exclusive, shared rights to the Hsp90 and Hedgehog pathway product development programs. In addition, Infinity could receive as much as $430 million more in milestone payments related to the companies' achieving certain late-stage clinical development and sales targets for any future products resulting from the collaboration.
"Hsp90 and Hedgehog are among the most attractive targeted therapy opportunities in cancer research today, and the Infinity programs have a very strong competitive position," said Edward T. Mathers, MedImmune's executive vice president, corporate development and venture. "With IPI-504, we have a promising drug candidate with already-established preclinical in vivo proof of concept and the potential to reach the market by 2010. In collaboration with Infinity, we plan to accelerate development of the intravenous formulation of IPI-504, as well as to expand into additional tumor types. In addition, we expect to be able to commence clinical testing of the next generation oral formulation of IPI-504, as well as an oral formulation of a hedgehog inhibitor within the next 12 to 18 months."
For each of the programs, Infinity will retain primary responsibility for discovery, preclinical development and translational clinical development of products through proof-of-concept in humans. The companies will jointly conduct clinical development through first product approval. MedImmune will lead worldwide regulatory strategy as well as sales and marketing of resulting products; Infinity retains an option to co-promote any future products in the U.S., contributing as much as 35% of the total promotional effort.
Posted on August 28, 2006 @ 02:29 pm
SFBC International has changed its name to
PharmaNet Development Group, Inc. after receiving approval from its shareholders at the annual meeting. The company has also named
John P. Hamill to the role of executive vice president and chief financial officer,
David Natan to executive vice president, Reporting and Analysis, and chief accounting officer, and
Thomas J. Newman, M.D. to executive vice president, Late Stage Development. Dr. Newman will retain his responsibilities as chief operating officer of the company's late-stage business. In addition,
Anne-Marie Hess was appointed executive director, investor relations and corporate communications.
"The PharmaNet Development Group name builds on the reputation and prominent market positions of PharmaNet, Anapharm and our other subsidiaries as a leading drug development organization committed to patient safety and providing excellent service and integrated global drug development capabilities to our clients," said Jeffrey P. McMullen, president and chief executive officer of PharmaNet Development Group. "We have realigned corporate functions and established the right corporate executive management team to focus on building a long-term, sustainable business that will enhance client and shareholder value."
The company's early-stage clinical development business will continue to operate under its existing brands, including Anapharm, and the late-stage clinical development business will continue to operate under its existing brand, PharmaNet.
Posted on August 25, 2006 @ 09:08 am
Peter R. Young, Ph.D. has joined
Genelabs Technologies as vice president, biology. Dr. Young joins the company from Celera Genomics, where he served as vice president, biology. He reports to
Ronald C. Griffith, Ph.D., Genelabs' chief scientific officer.
Prior to Celera, Dr. Young was vice president, research at Sugen, Inc. and previously was director, metabolic disease with DuPont Pharmaceuticals and Bristol Myers Squibb and director, molecular biology with SmithKline Beecham. He is an inventor on 44 U.S. patents and has published more than 100 abstracts and papers.
Also, the company's chief financial officer,
Matthew Loar,
will be leaving the company on September 1st to accept a position at a biotechnology company. Genelabs has initiated a search for a replacement, and Mr. Smith will assume Mr. Loar's responsibilities until a new chief financial officer is named.
Posted on August 25, 2006 @ 09:05 am
Bilcare has launched U.S. slitting operations in its Phoenixville, PA facility, which houses a state-of-the-art Slitter Rewinder. According to the company, this will shorten lead-times and enable quick delivery to pharmaceutical industry customers.
The company's slitting operation features: full computer control, improved, uniform web and roll tension control, programmable auto knife positioning, accurate edge wind control, an auto unloading system to reduce changeover time and run speeds as high as 1,000 ft./min. Also, three static eliminator bars strategically positioned on the machine eliminate static of slit rolls. The slitter operation is also capable of using an online modem for remote diagnostics for reduced downtime.
The company’s packaging features include: slit rolls wrapped in black, stretched film, core plugs for added strength, edge guards on the top and bottom circumference, 250 lb.-tested double-walled white cartons—which are taped and strapped—and all skids are strapped and stretched wrapped.
Posted on August 25, 2006 @ 09:04 am
GlaxoSmithKline received approval for Relenza antiviral treatment for use in the prevention of influenza in 15 European countries. Relenza may be given to adults and children age five and older to prevent flu. The drug, which is inhaled, was also approved for treating flu in children age 5 and older. Relenza was previously approved in Europe for the treatment of flu in adults and children age 12 and older.
Relenza received FDA approval for the prevention of influenza in adults and children 5 and older this past March.
Posted on August 24, 2006 @ 09:44 am
Mark Ignaczak has been promoted to project manager within
DPT’s marketing and project management group. In his new role, Mr. Ignaczak will join a team of colleagues at DPT's Lakewood, NJ site. He will be responsible for leading projects through the development process by partnering closely with business development to help secure new business, and managing projects to commercialization.
“Mark’s arrival in project management is an apt example of DPT’s increasing commitment to providing talented, dedicated employees with opportunities for development and advancement,” said project management director Jorge Araujo.
Mr. Ignaczak has worked as a supervisor in the process department since joining the company in May 2005. Previously he worked at Wyeth Pharmaceuticals in the bioprocess development area.
Posted on August 24, 2006 @ 09:42 am
Cardinal Health has named
David H. Lees, Ph.D., to the post of president of Cardinal Health Canada, signaling the company's regard for Canada as an important component to its overall strategy of expanding the market for its products and services outside the U.S. Dr. Lees will be responsible for leading Cardinal's Canadian operations, as well as developing and implementing the company's growth strategy for Canada. He will report to
Jeff Henderson, chief financial officer.
"Canada is one of the world's largest health-care markets and, therefore, vital to the goals we've outlined to grow the market for our products and services and serve health-care customers worldwide," said R. Kerry Clark, chief executive officer, Cardinal Health. "We are fortunate to have a leader in David, whose track record of success for growth is well proven."
Dr. Lees joined the company with the acquisition of Source Medical, a distributor of medical and surgical supplies in Canada, where he served as president and chief executive officer for the past seven years. He will continue to be based at Cardinal's offices in Mississauga, Ontario. Prior to joining Source Medical, Dr. Lees held senior executive positions with a number of Canadian enterprises, most recently, Canada Bread Co., Ltd., where he was president and chief executive officer for six years.
Posted on August 24, 2006 @ 09:38 am
GlaxoSmithKline and
ChemoCentryx, Inc. have entered a worldwide multi-target strategic alliance to discover, develop and market novel medicines targeting four chemokine and chemoattractant receptors for the treatment of a variety of inflammatory disorders, including Traficet-EN in late stage development for the treatment of inflammatory bowel disease (IBD). This collaboration provides GSK access to selected targets from a broad pipeline of chemokine-based therapeutics. The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery (CEEDD).
ChemoCentryx will receive an upfront payment of $63.5 million comprised of cash and an equity investment. Also, ChemoCentryx will receive research funding and will be eligible to earn milestone payments of as much as $1.5 billion across six product options on the four targets, assuming successful development and commercialization. ChemoCentryx will also receive double-digit royalties on all collaboration product sales and will be able to increase royalties in certain instances by co-funding development through Phase III trials. Additionally, under certain circumstances, upon an initial public offering by ChemoCentryx, GSK will invest in ChemoCentryx's common stock.
Under the terms of the agreement, ChemoCentryx will be responsible for the discovery and development of small molecule drug candidates targeting four specific chemokine and chemoattractant receptor targets through clinical proof of concept, at which point GSK will have exclusive options to license each product for further development and commercialization on a worldwide basis.
"We are extremely pleased to be working closely with GSK as a premier global pharmaceutical company. Their outstanding commitment to pharmaceutical innovation and broad expertise and experience in the development and commercialization of new medicines in inflammatory conditions make them an ideal collaborator," said Thomas J. Schall, Ph.D., president and chief executive officer of ChemoCentryx. "This important alliance with GSK will provide us with access to significant capital in the near and long term to support the ongoing development of each of these programs, as well as the ability to continue to discover and bring forward multiple new compounds targeting the chemokine system."
Maxine Gowen, Ph.D., senior vice president and head of GSK's CEEDD stated, "The ChemoCentryx alliance is a landmark relationship for the CEEDD. This collaboration clearly demonstrates GSK's commitment to gain access to leading-edge, best anywhere science and we are excited by the opportunity to work with ChemoCentryx, the leading chemokine company, and their world class team. Accessing their expertise and four advanced chemokine programs, including, Traficet-EN in the clinic for IBD, will allow us to bring novel medicines to patients with high unmet need."
Posted on August 23, 2006 @ 10:32 am
QSV Biologics has signed a second contract with
Tissue Therapies Ltd. for the cGMP manufacture of clinical quantities of synthetic Vitroonectin and a single protein, chimeric form of VitroGro, called VitroGro-1. Tissue therapies will use these materials in preclinical and clinical trials early next year. Under the agreement QSV will be responsible for technology transfer and cGMP production in QSV's licensed manufacturing facility. Terms of the final manufacturing contract have not been disclosed.
Dr. Graeme Macaloney, QSV's founder and chief executive officer, said, "This represents repeat business with Tissue Therapies whereby we are now making several products for them. The high productivity cell culture manufacturing processes used for these products differ from earlier processes that we have been developing for them, but represent processes that our staff are experienced to deal with."
Dr. Steven Mercer, Tissue Therapies chief executive officer, said, "QSV earned this extra business with their reliable, efficient and timely communications throughout all phases of delivering contract manufacturing services and their track record for delivering on time and within budget. VitroGro-1 represents a novel line of innovative chimeric products to be incorporated in to our VitroGro platform, while Vitronectin, will be used in other multiprotein formulations of VitroGro. I have great confidence that these ground-breaking products are in safe hands with QSV."
Posted on August 23, 2006 @ 10:29 am
AAIPharma, Inc. has made two new additions to its management team.
Lee Karras joins the company as senior vice president, non-clinical services, and
Anne Wiles has been named as senior vice president, data systems and processes.
"We are pleased to add Lee and Anne to our management team. As we develop and pursue strategies to bring innovation and productivity to drug development both in our non-clinical and clinical operations, their experience and expertise will be invaluable and instrumental to our organization's continued growth and success," stated Ludo Reynders, Ph.D., AAIPharma president and chief executive officer.
Mr. Karras has more than 15 years of experience in pharmaceutical operations. He will focus on building a best-in-class infrastructure for the company's North American non-clinical business. Most recently, he served as a consultant for pharmaceutical and biotech companies in the areas of technical operations, FDA compliance, supply chain operations and strategic planning. Prior to this, he served as vice president of contract services for Baxter Healthcare. Previously, he served Baxter as vice president of operations.
Ms. Wiles, whose professional focus is clinical data technology, will play a critical role in advancing the company's clinical processes and technologies worldwide. She joins the company from INC DataSpectrum, the data services subsidiary of INC Research, where she served as president. Prior to this, she served IBM Life Sciences as executive consultant, responsible for the development of solutions to e-enable the clinical development process for pharmaceutical, biotechnology, CRO and medical device companies.
Posted on August 23, 2006 @ 10:28 am
Dan L. O’Korn has joined
Hunton & Williams' Raleigh office as a partner with its life science practice, a multidisciplinary group of more than 45 lawyers with patent, FDA, litigation and corporate experience. He joins the firm as part of its commitment to strengthen the firm’s biotechnology law practice in North Carolina, where he will focus on pharmaceutical and biotech transactions and FDA-related regulatory matters.
Mr. O’Korn has more than 13 years of legal experience, the majority of it devoted to the pharmaceutical industry. Most recently, he served as the vice president and general counsel of Xanodyne Pharmaceuticals, a privately owned pharmaceutical company committed to women’s health and pain management. Prior to that, he was senior corporate counsel at AAIPharma, Inc. in Wilmington, NC, where he served as lead attorney on several major product acquisitions and divestitures. Before joining AAIPharma Inc., he worked with Lilly, where he focused on complex product acquisitions and divestitures as well as general commercial transactions.
“Dan O’Korn is an invaluable addition to our firm,” says William S. Patterson, managing partner of the Raleigh office of Hunton & Williams. “The need for sophisticated counsel with life sciences experience continues to grow in the Triangle and elsewhere. Dan’s extensive background both complements our existing capabilities and adds a strong dimension of experience to our client service.”
Posted on August 23, 2006 @ 10:26 am
Glenn Kerkhof has been appointed chief executive officer,
Chiltern International. Mr. Kerkhof has more than 13 years of management experience in the pharmaceutical services industry. He joins the company from Charles River Laboratories, where he served as the vice president of global operations for clinical services and was responsible for operating a business unit comprised of more than 1,100 people in 20 countries. Prior to Charles River, he served at as vice president of operations for clinical services for Inveresk Research Group in Europe and Asia Pacific.
"Glenn brings to Chiltern strong leadership, senior operational experience and extensive knowledge of the pharmaceutical services industry from serving as the head of global clinical operations at Charles River Laboratories and Inveresk Research Group, two leading international CROs," said Nick Thornton, vice chairman of Chiltern International. "Glenn's expertise in global clinical services will help Chiltern maintain high standards of quality and leverage considerable opportunities for growth around the world."
Mr. Kerkhof's appointment follows the recent acquisition of Chiltern International by Czura Thornton, a private investment group led by Antony Czura and Nick Thornton.
Posted on August 22, 2006 @ 09:31 am
Gentris Corp. has entered an exclusive 10-year licensing agreement with
Falco Biosystems, Ltd. medical testing laboratories in Japan. The agreement establishes Japan’s first GLP-compliant pharmacogenomics laboratory. The partnership, to be called "Gentris Japan," will offer pharmacogenomics services to the pharmaceutical industry in Japan, the second-largest pharmaceutical market in the world after the U.S.
"It is evident that pharmacogenomics is going to be as important to drug development, and ultimately the public, in Japan as it is in the U.S. and Europe," commented Gentris chief executive officer Michael Murphy. "For several drugs routinely prescribed in Japan, research has identified clear relationships between individual genetic differences and how these drugs are metabolized. Gentris Japan will work to ensure that people receive safer and more effective medications, at the appropriate dosage, based on these individual genetic variations."
"Our mission is to help society achieve higher standards of living and health through information, technology and services," said Falco chairman and president Hiroharu Akazawa. "Partnering with Gentris to introduce the first GLP-compliant pharmacogenomics laboratory in Japan is a great step in the advancement of personalized medicine. Gentris' superior standards of practice and longstanding leadership in the field of pharmacogenomics make the company an ideal partner for Falco. We look forward to working together to bring safer and more effective drugs to the Japanese public."
Posted on August 22, 2006 @ 09:29 am
Lpath, Inc. and
Laureate Pharma have entered into an agreement for the production of recombinant Sphingomab, Lpath's humanized monoclonal antibody specific for sphingosine-1-phosphate (S1P). It is designed for use as a potential therapeutic for diseases like cancer and various ocular and cardiovascular conditions. Laureate will provide cell line development, optimization, and upstream and downstream process development, followed by cGMP manufacture of the product for use in clinical trials.
"Lpath has developed an impressive and unmatched ability to generate monoclonal antibodies against bioactive lipids," notes Robert J. Broeze, Ph.D., president and chief executive officer of Laureate Pharma. "We are excited Lpath has chosen Laureate Pharma to design and implement a manufacturing process that will make this medical breakthrough available for clinical trials."
Dr. Bill Garland, Lpath's vice president of preclinical development, commented, "Given Laureate's decades of experience producing monoclonal- antibody therapeutics and their state-of-the-art facilities, Laureate Pharma was a compelling choice for Lpath and a great fit with our manufacturing strategy."
Posted on August 22, 2006 @ 09:26 am
Althea Technologies has been awarded a contract from
Altus Pharmaceuticals to produce its ALTU-238 product candidate, a crystallized formulation of Human Growth Hormone (HGH) that is designed to be administered once-weekly through a fine gauge needle for the treatment of HGH disorders.
"Althea Technologies is a seasoned CMO with significant experience in the manufacture of recombinant proteins," said Sheldon Berkle, president and chief executive officer of Altus. "We look forward to working together through technology transfer and the installation and qualification of the key equipment necessary for the production of ALTU-238. We feel confident in their ability to manufacture reliable quantities of ALTU-238 for our planned Phase III trials that meet our high standards of quality and patient safety."
Althea Technologies will manufacture the Phase III trial material of ALTU-238 human growth hormone in its newly expanded cGMP manufacturing facilities at its San Diego, CA campus. President and co-chief executive officer of Althea, Dr. Magda Marquet, added, "We are pleased that Altus Pharmaceuticals selected Althea Technologies to manufacture their innovative ALTU-238 product. As a leader in providing highly technical drug development services to the industry, we are committed to working with Altus to effectively and efficiently manufacture ALTU-238."
Posted on August 21, 2006 @ 09:47 am
Eli Lilly and Co. received an approvable letter from the FDA for ruboxistaurin mesylate (proposed trade name Arxxant), its investigational oral therapy for treatment of diabetic retinopathy (DR), a diabetic eye disease.
As part of the letter, the FDA has requested additional data to support the clinical evidence presented by the company in its NDA. Lilly plans to meet with the FDA to determine whether this request can be satisfied with data from an ongoing study or whether a new study is required.
"We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward," said Dr. Timothy R. Franson, Lilly's vice president of global regulatory affairs.
Arxxant works by limiting the overactivation of protein kinase C beta (PKC b), a naturally occurring enzyme that has been linked to the development of diabetic retinopathy. It is the first of a new class of compounds being investigated for the treatment of moderate to severe non-proliferative diabetic retinopathy.
Posted on August 21, 2006 @ 09:46 am
Alnylam Pharmaceuticals has granted
Calando Pharmaceuticals an InterfeRx license to discover, develop, and commercialize an RNAi therapeutic towards a cancer target utilizing a synthetic siRNA, together with Calando's proprietary delivery technology. As part of the agreement, Calando also has an option to acquire an InterfeRx license for a second target gene. Financial terms were not disclosed, but include upfront, annual, and milestone payments, and royalties on sales of any products covered by the licensing agreement.
"Alnylam established the InterfeRx licensing program to provide access to our leading intellectual property estate for disease targets in areas outside the scope of our current research. We are pleased to be granting this license to Calando to enable their efforts with Alnylam intellectual property, which we believe is critical for the development and commercialization of RNAi therapeutics," said John Maraganore, Ph.D., president and chief executive officer of Alnylam.
"Calando is focused on designing, developing, and commercializing RNAi therapeutics to treat serious medical conditions, such as cancer, by combining effective siRNAs with our patented and proprietary systemic delivery technologies," said John Petrovich, president and chief executive officer of Calando Pharmaceuticals. "This license from Alnylam is an important step in our efforts to develop and commercialize novel RNAi therapies for serious diseases and conditions requiring systemic delivery."
Posted on August 21, 2006 @ 09:44 am
Sentry Logistic Solutions has a new service offering designed to provide build-to-suit facilities and customized cold chain storage and logistics solutions for global pharmaceutical and biopharmaceutical firms. These new services pair the benefits of outsourcing the storage and logistics functions with the advantages of fully customized facilities and compliant processes, according to the company.
"Sentry's build-to-suit solution is a logical extension of our expertise in the biopharmaceutical industry, proven project management skills, property development experience and ability to rapidly deploy specialized cold storage facilities," said Jennifer Marcum, Sentry's chief executive officer. "This service was developed in response to the growing demand from large pharmaceutical and biotechnology firms that want to harness the efficiencies of the outsourced cold storage and logistics model, but that have precise equipment, facility, storage, shipping and security requirements that most vendors cannot or will not accommodate."
The build-to-suit and customization options, according to the company, help pharma and biopharma firms reduce distribution costs, create new efficiencies, minimize operating costs and reduce time-to-market. The company plans to use its five acres of land located in a foreign trade zone area in Indianapolis, IN for future development and has options to purchase additional acreage.
The company's new offerings employ best-practice approaches for developing validated cold storage facilities that are compliant with all applicable industry standards and regulations. Special features can include segregated storage areas, dispensing suites, dedicated utilities and unique safety, security, electrical, structural and architectural design configurations.
Posted on August 18, 2006 @ 09:14 am
Glatt Pharmaceutical Services, a division of Glatt Air Techniques, Inc., has made several appointments as part of its expansion initiative.
Robert Femia, Ph.D. has been named vice president of R&D at Glatt Pharmaceutical Services. Dr. Femia has more than 20 years' experience in pharmaceutical product and analytical chemistry development. Prior to joining the company, he was the executive vice president of pharmaceutical research at Par Pharmaceuticals where he lead the development of many generic products and the companies first approved NDA for an extended release product. His responsibilities at Glatt will be to manage its growing R&D services to the pharmaceutical industry in addition to Glatt’s internal product development efforts.
Bill Bundenthal has joined the company as vice president of operations. He has more than 20 years of experience in management of manufacturing operations. Prior to joining the company he was vice president of manufacturing operations and facility engineering at Par Pharmaceuticals and held previous positions at Lederle Laboratories and Barr Pharmaceuticals. His responsibilities at Glatt include overseeing the completion of a multi-million dollar facility expansion to increase capacity and capabilities, including organic solvent and modified release processing in both its R&D and commercial manufacturing areas. Mr. Bundenthal will also be responsible for the commercial manufacturing operations, warehousing, and facility engineering.
Both Dr. Femia and Mr. Bundenthal will report to
Oliver Mueller, executive vice president, Glatt Pharmaceutical Services.
Posted on August 18, 2006 @ 09:12 am
Schering-Plough received clarification regarding the expiration date for its rights to market golimumab worldwide, excluding the U.S., Japan and certain other Asian markets. In August 2005, Schering-Plough and
Centocor stated that they were working together to move forward with their collaboration on golimumab and were taking steps to resolve the difference of opinion as to the expiration date.
Schering-Plough's rights to market golimumab will extend to 15 years after the first commercial sale in its territories. The company plans to launch golimumab in 2009 or 2010.
Developed by Centocor and Schering-Plough, golimumab is a fully-human monoclonal antibody being developed as a treatment for certain immune-mediated inflammatory diseases. Golimumab is currently being investigated in Phase III trials for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Posted on August 18, 2006 @ 09:10 am
Sanofi-Aventis and
Bristol-Myers Squibb received approval from the FDA for the sNDA for antiplatelet agent Plavix in the reduction in patients with acute ST-segment elevation myocardial infarction (STEMI) in the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death. STEMI is a severe acute heart attack in which a coronary artery is generally blocked completely. These blockages are caused by clot formation in the arteries, a life-threatening complication of an underlying disease known as atherothrombosis.
The FDA approval was based on the results of two trials of more than 48,000 patients in which STEMI patients treated with Plavix taken with aspirin and standard therapy were compared to STEMI patients treated with placebo taken with aspirin and standard therapy. Results demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by 7%, and reduced the relative risk of the combination of MI, stroke or death by 9%. In the second trial, clopidogrel taken with aspirin and other standard therapy including thrombolytics significantly reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by 36% by day eight of hospitalization or discharge.
Posted on August 17, 2006 @ 10:27 am
Crucell and technology partner
DSM Biologics have signed a second PER.C6 license agreement with
MorphoSys AG. This license agreement allows MorphoSys to use the PER.C6 cell line in the production of clinical grade material for the development of its proprietary therapeutic antibody program MOR103. MOR103 is a fully human HuCAL antibody, developed in the area of inflammatory diseases, such as rheumatoid arthritis.
Also, MorphoSys has signed a biopharmaceutical manufacturing agreement with DSM Biologics to produce the material in its FDA-approved facilities in Groningen, the Netherlands. Financial details on these agreements were not disclosed.
"Today's news shows that MorphoSys' MOR103 program is on track towards the next development stage - the filing of an IND in the second half of 2007," commented Dr. Marlies Sproll, chief scientific officer of MorphoSys. "This collaboration brings together a fully human antibody to treat inflammatory diseases with production capabilities in the same fully-human environment. Manufacturing human antibodies in such a manner offers several potential advantages over alternative production methods, especially when targeting chronic diseases such as rheumatoid arthritis."
"We are very pleased that respected antibody companies like Morphosys are being convinced of the advantages of PER.C6 for antibody production," said Dr. Jaap Goudsmit, Crucell's chief scientific officer. "As we have seen with vaccines, PER.C6 is increasingly being accepted as the cell substrate for the production of antibodies."
"We are very pleased that MorphoSys continues to successfully utilize the PER.C6 cell line, and that they have chosen DSM Biologics as their preferred manufacturing partner," said Terry Novak, business director and chief marketing officer at DSM Biologics. "It is exciting that we are combining two strong platforms for fully human antibodies."
Posted on August 17, 2006 @ 10:26 am
Hana Biosciences initiated a multi-center Phase II trial of Marqibo in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). This study is designed to support a Phase III trial of Marqibo for the treatment of ALL.
The Phase II open-label study will assess efficacy of weekly doses of Marqibo plus pulse dexamethasone as measured by complete response rate. Secondary objectives are evaluation of safety and disease-free survival. This study is the Phase II portion of an ongoing Phase I/II trial. Hana expects to enroll as many as 44 patients in the Phase II Simon's two-stage designed trial. Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) patients are eligible to enroll in the study.
Posted on August 17, 2006 @ 10:19 am
Akorn, Inc. has submitted the first ANDA with the Office of Generic Drugs on behalf of FDC, Ltd. (FDC). The two companies signed a purchase and supply agreement in July 2004. FDC is an Indian manufacturer and marketer of ophthalmic pharmaceutical products. The proposed drug product is an ophthalmic solution that will be manufactured by FDC in a blow-fill-seal container closure system.
FDC will develop, manufacture and supply finished dosage form drug products to Akorn, which is responsible for filing FDA regulatory submissions on behalf of FDC. Akorn has exclusive U.S. marketing rights to all drug products filed on behalf of FDC.
Posted on August 16, 2006 @ 10:54 am
Pfizer's newly appointed chief executive officer,
Jeffrey B. Kindler, has announced a new leadership organization to streamline the company's operations and speed decision-making.
Mr. Kindler said, "Our new organizational structure builds on the strengths of our company while responding to the accelerating changes in the environment in which we operate. This will put us in the best position to capitalize quickly on the enormous opportunities ahead of us through increasing support for successful new medicines, forging partnerships with key customers, entering into co-promotion and licensing agreements, investing in new technologies to add value to our core product offerings, or acquiring new products and services from outside the company."
According to Mr. Kindler, David Shedlarz, vice chairman, will be assuming expanded responsibilities, including Pfizer global manufacturing, worldwide strategic planning, licensing and business development and technology. "To his new role as my principal deputy, David brings strategic insight, years of experience in our industry and many important accomplishments achieved during his distinguished career at Pfizer," said Mr. Kindler.
The new executive leadership team, which Mr. Kindler said, "brings together all the essential elements necessary for us to compete in this new era for healthcare," includes the senior-most leadership, management and decision-making body of the company. It consists of Mr. Shedlarz; PGRD president John LaMattina, whose role reflects the importance of science to the company's future; worldwide pharmaceuticals operations president Ian Read, will lead an integrated global unit; chief medical officer Dr. Joe Feczko; worldwide talent development and human resources leader Sylvia Montero; general counsel Allen Waxman; and worldwide public affairs and policy leader, Rich Bagger.
Pointing to the advantages of a streamlined leadership structure, Mr. Kindler told colleagues that among the opportunities the company will pursue are: growing its portfolio of research opportunities and expand genomics and biologics; building upon a broad and diverse pool of talent from both Pfizer colleagues as well as from outside the company; speeding the development of patient support and compliance programs to enhance the value of Pfizer medicines to patients; and harnessing technology for the company's competitive advantage, both internally and with respect to the company's customer offerings.
Also, vice chairman
Karen Katen will be leaving the company to pursue other opportunities. She will provide advice and leadership over the next several months in several areas, including Pfizer Health Solutions and Pfizer Healthy Directions, as well as healthcare policy.
Posted on August 16, 2006 @ 10:52 am
Evotec AG has achieved the second milestone in its four-year Alzheimer's drug discovery collaboration with
Takeda Pharmaceutical Co. Ltd., triggering a milestone payment of more than $1.3 million. Evotec granted Takeda exclusive rights to a novel target in Alzheimer's disease. Evotec is now eligible for future milestone payments on the successful development of compounds acting on the selected target. Also, Evotec is entitled to further milestone payments should Takeda select additional targets from Evotec's target database.
Dr. John Kemp, executive vice president R&D at Evotec, said, "We are extremely proud that we have reached our second project milestone with Takeda. Over the past three years we have made excellent progress in building substantial expertise and IP around novel Alzheimer's disease targets. The relationship with Takeda is very productive and we are looking forward to jointly leveraging our innovative Alzheimer's disease toolbox during the years to come."
Posted on August 16, 2006 @ 10:50 am
Northwest Biotherapeutics, Inc. awarded a contract to
Synteract for the clinical trial management of its Phase II trial to evaluate DCVax-Brain in patients with Glioblastoma multiforme. DCVax-Brain is a personalized therapeutic cancer vaccine using the patient's own dendritic cells (immune cells) with the patient's own tumor biomarkers (antigens).
"We are pleased to be working with Synteract in this important clinical trial given their longstanding expertise in successful clinical trial management," stated Alton Boynton, Ph.D., president of Northwest Biotherapeutics. "It will be particularly useful, as this Phase II trial has the potential to become one of the first cancer immunotherapies, an entirely new class of treatment for brain cancer."
Stewart Bieler, senior vice president of clinical operation and project management at Synteract, said, "We are enthusiastic about working with Northwest Biotherapeutics to bring one of the first personalized medicines into a late stage clinical trial -- especially for a disease like brain cancer, for which very few treatments currently exist and for which the prognosis is especially dire."
This Phase II trial is based on two Phase I trials demonstrating that patient survival was more than twice as long for patients receiving DCVax-Brain treatment than for patients receiving either of the two currently FDA-approved therapies.
Posted on August 15, 2006 @ 10:13 am
Barr Pharmaceuticals' Duramed subsidiary has signed a product acquisition agreement with
Shire for Adderall tablets, as well as a product development agreement for six proprietary products. Also, Barr Laboratories, Inc. has signed a settlement and license agreement relating to two pending patent cases involving Shire's Adderall XR. The agreements will be submitted to the U.S. Federal Trade Commission as required by law and become effective upon the Courts' signing of consent judgments in the two pending cases.
"We believe the agreements provide an equitable resolution to our Adderall XR patent litigation that creates a significant benefit for consumers, as well as the company's shareholders," said Bruce L. Downey, Barr's chairman and chief executive officer. "The agreements enable a pro-competitive and pro-consumer introduction of a generic version of Adderall XR more than nine years earlier than might otherwise have been possible. It will also result in an investment in R&D for six products initially, which will enhance our ability to expand our proprietary development activities. Finally, it provides us immediate access to the immediate-release Adderall brand product, a generic version of which we have manufactured and marketed since 2002."
Under the terms of the product acquisition agreement, Duramed will pay Shire $63 million for its Adderall tablets. This agreement is subject to reporting under the U.S. Hart-Scott-Rodino Act.
Barr currently manufactures and markets a generic version of Adderall that it first launched in February 2002. Adderall is indicated as part of a treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity.
In a separate development agreement, Duramed granted Shire a license to obtain approval for and market its recently approved Seasonique tablets extended-cycle oral contraceptive product and five products in various stages of development utilizing Duramed's transvaginal ring technology. Shire will pay Duramed an initial $25 million for previously incurred product development expenses, and will reimburse Duramed for development expenses of as much as $140 million during an eight-year period, not to exceed $30 million per year. Upon approval, Duramed will retain rights to market and promote these products in North America, Central and Eastern Europe and Russia, while Shire will maintain the same rights in the rest of the world, including five countries in Western Europe.
The settlement and license agreements permit Barr to launch a generic version of Adderall XR, under terms of a license beginning April 1, 2009, nine years earlier than the last-to-expire Shire patent, or earlier under certain circumstances such as the launch of another party's generic version of Adderall XR. The license will be exclusive for the first 180-days following Barr's launch. Barr would pay Shire a royalty equal to a portion of profits from the sales of generic Adderall XR. As part of the settlement, Barr agrees that Shire's patents are valid and enforceable and that its generic product infringes one of the Shire patents.
Posted on August 15, 2006 @ 10:11 am
Gilead Sciences has signed non-exclusive license agreements to provide generic versions of tenofovir disoproxil fumarate (sold by Gilead under the brand name Viread) to three generic manufacturers in India. These license agreements grant to
Emcure Pharmaceuticals,
Hetero Drugs and
Strides Arcolab the rights to produce and distribute generic versions of tenofovir to 95 low-income countries around the world, including India.
The license agreements require that the generic manufacturers meet certain regulatory standards and include a technology transfer to enable rapid production of large volumes of high-quality generic versions of tenofovir. These agreements also allow the manufacture of co
Magazine
