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.

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. 

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."

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.

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."

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."

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.

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."

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."

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.

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."

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.”

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."

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."

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."

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."

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.

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."

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.

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."

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.

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."

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.

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.

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."

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.

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."

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.

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.

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.

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.

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.

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."

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. 

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." 

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."

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."

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.

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."

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.”

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.

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."

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."

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.

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.

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."

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.

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.

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.

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