December 2008
Posted on December 31, 2008 @ 12:01 pm
Nektar Therapeutics has sold some of its pulmonary delivery assets, technology, and intellectual property to
Novartis for $115 million in cash. Novartis now owns "certain dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment and manufacturing facility lease obligations," according to a Nektar statement. The sale also transferred to Novartis approximately 140 Nektar personnel, as well as certain IP and manufacturing methods, including manufacturing and royalty rights to Novartis' Tobramycin inhalation powder (TIP) program.
Nektar continues to own its Bayer HealthCare-partnered program NKTR-061 (Amikacin Inhale) and royalties from the Ciprofloxacin inhaled powder program (CIP), also partnered with Bayer HealthCare. In addition, Nektar retains its NKTR-063 (inhaled vancomycin) program, as well as all intellectual property specific to inhaled insulin.
Posted on December 30, 2008 @ 08:12 am
Roger Viney, Ph.D. has been named director of sales & marketing Europe and Asia for
Hovione.
Thomas Eisele, Ph.D. has been named general manager R&D at the company and
Steve Beagle has been named director of sales & marketing, North America.
Dr. Viney will lead Hovione's sales and marketing efforts outside North America and is based at Hovione headquarters in Loures, Portugal. Steve Beagle will lead those efforts for the North America territory and is based at the Hovione's Technology Transfer Center in New Jersey. Both Dr. Viney and Mr. Beagle are responsible for the development of sales and marketing strategies in line with the strategies of Hovione's four business units: Exclusive, Particle Design, Generics and Pharma. Dr. Eisele is responsible for corporate R&D and reports to chief executive officer Guy Villax. The R&D group includes Process Chemistry, Analytical Chemistry, Particle Design, Project Management and Pilot Plant.
"We are pleased to welcome Roger, Thomas and Steve to the Hovione team," said Mr. Villax. "These three individuals have a distinguished track record in the industry and their extensive experience will be an invaluable resource to the company and broadens the executive management team at an important stage in the growth of our business."
Prior to joining Hovione, Dr. Viney held various positions at Rhone-Poulenc/Rhodia from 1993 to present, most recently in Global Business Management. Prior to that he worked in senior roles in sales, marketing and technical management.
Dr. Eisele worked in Switzerland for 13 years in the area of Custom Research and Custom Manufacturing at CarboGen-Amcis, Rohner and SynphaBase. During that time Dr. Eisele held several positions in R&D, marketing and sales, global business development, shared services and general management. He began his professional career at Nycomed in the area of Medicinal Chemistry.
Mr. Beagle has a diverse 24-year history working in global roles within the pharmaceutical industry ranging from product management to sales and marketing. He is well known in the pharmaceutical manufacturing community and brings a wealth of knowledge to this position. Most recently he was at DSM where he was senior director of Business Development. Prior to this position he was at Stiefel Laboratories where he held management positions in Business Development and Technical Service. Mr. Beagle has also worked for BASF, American Cyanamid, and R.W. Greeff.
Posted on December 30, 2008 @ 08:01 am
King Pharmaceuticals has initiated the Phase II trial evaluating the efficacy and safety of T-62, an investigational drug for the treatment of neuropathic pain.
Dr. Eric Carter, chief science officer of King, remarked, “T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body’s endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition.”
The Phase II trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in as many as 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a seven-day screening period, a 28-day treatment period, and a 14-day post-treatment period.
Posted on December 30, 2008 @ 07:58 am
Matthew K. Fust has been named executive vice president and chief financial officer of
Onyx Pharmaceuticals. Mr. Fust will serve as Onyx's principal financial and accounting officer and report to
N. Anthony Coles, M.D., the company's president and chief executive officer.
"Matt is a proven leader who brings extensive senior management and operational experience to Onyx, as well as a shared strategic vision to create a leading biopharmaceutical company," said Dr. Coles. "His demonstrated capabilities in implementing corporate and financial strategies and accelerating corporate growth have been reflected throughout his career. On behalf of the board and the other members of the executive team, it is a pleasure to welcome Matt."
Most recently, Mr. Fust was executive vice president and chief financial officer at Jazz Pharmaceuticals, which he joined in 2003. From 2002 until 2003, he was chief financial officer at Perlegen Sciences, a biotechnology company. Previously, he served as senior vice president and chief financial officer at Alza Corp. where he was an executive from 1996 until 2002. From 1991 until 1996, Mr. Fust was a manager in the healthcare strategy practice at Anderson Consulting.
Posted on December 30, 2008 @ 07:53 am
Actavis Inc. has reached agreement with the FDA on a Consent Decree of Permanent Injunction the company’s Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.
The decree only affects operations at Actavis Totowa in NJ. These include two oral-dose manufacturing sites, and one packaging facility. Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s cGMP and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.
“We have been working with the FDA to address compliance issues at the Totowa facilities,” said John LaRocca, Actavis Inc.’s chief legal officer. “We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the FDA is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”
Prior to reaching this agreement, Actavis engaged
Parexel to assess Actavis Totowa facilities. Parexel has 25 years of experience in helping companies bring safe and effective treatments to the global marketplace. Parexel will continue to work with Actavis Totowa to facilitate ongoing compliance with the Consent Decree, according to an Actavis statement.
Posted on December 30, 2008 @ 07:49 am
The FDA has accepted
Savient Pharmaceuticals' BLA for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted Savient's BLA a priority review status which accelerates the review period to six months. This designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date for an FDA decision on pegloticase is April 30, 2009.
The BLA submission is based on the two replicate, six-month Phase III clinical trials, performed under the auspices of a special protocol assessment. Additionally, the BLA includes data from the open label extension (OLE) study for pegloticase, per the request of the FDA. The OLE study allowed those patients who completed the Phase III trials to continue or begin receiving pegloticase for an extended period of time. The data set includes 101 patients with at least twelve months of continuous treatment. Pegloticase was previously granted orphan drug designation by the FDA.
Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol at the maximum medically appropriate dose or for whom allopurinol is contraindicated.
Posted on December 23, 2008 @ 08:47 am
GlaxoSmithKline and
Archemix Corp. have entered a worldwide strategic alliance to discover, develop and commercialize aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. Aptamers are synthetized oligonucleotides, or short nucleic acid sequences, that bind to proteins with high affinity and specificity.
The alliance leverages Archemix’s expertise and intellectual property in the discovery and development of aptamer therapeutics and provides GSK with an option to license product candidates directed at seven different aptamer targets related to inflammatory disease.
Under the terms of the agreement, Archemix will receive $27.5 million in upfront payments, including a $6.5 million equity investment by GSK in the company. Archemix could also be eligible to receive as much as $200 million in development, regulatory and sales milestones for each of the seven aptamer therapeutics which may be discovered and developed as part of the alliance. Archemix would also receive tiered royalties on worldwide sales of products that may result from the alliance.
Archemix will be responsible for the discovery and development of the aptamer therapeutics through clinical proof of mechanism, unless GSK chooses to exercise its option earlier. GSK would then have an exclusive license to drug candidates developed under each program for further development and commercialization on a worldwide basis. Archemix will have the right to develop and commercialize any aptamer therapeutics that GSK does not select.
“We are very excited about this collaboration with GSK. GSK is an outstanding partner with leadership and expertise in inflammation, and we look forward to expanding our efforts in inflammation where aptamers could offer novel options to treat disease,” said Errol DeSouza, Ph.D., president and chief executive officer of Archemix. “This is another step forward in our strategy to leverage our intellectual property estate together with our significant internal capabilities in order to develop aptamers for a variety of therapeutic areas with key partners who are experts in their field.”
"This innovative multi-target drug-discovery deal is an important extension of our externalization strategy and provides GSK with an outstanding opportunity to work with the world leader in aptamer discovery and development," said Jose Carlos Gutierrez-Ramos, Ph.D., senior vice president and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery in GSK. "The application of aptamers with their unique properties is an exciting opportunity that holds enormous potential for the treatment of many devastating diseases of the immune system."
Posted on December 23, 2008 @ 08:42 am
Forest Laboratories, Inc. and
Pierre Fabre Medicament have entered into a definitive collaboration agreement to develop and commercialize F2695 in the U.S. and Canada. F2695 is a selective norepinephrine and serotonin reuptake inhibitor being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.
Under the terms of the agreement, Pierre Fabre will receive an upfront payment of $75 million and is eligible to receive milestone payments and royalties on sales. Forest will be responsible for the clinical development and commercialization of F2695 in the U.S. and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide.
"We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004," commented Howard Solomon, chairman and chief executive officer of Forest. "We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market."
"Pierre Fabre is looking forward to working with Forest on this exciting product opportunity," said Jean-Pierre Garnier, chief executive officer of Pierre Fabre Medicament. "Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695."
In a recently completed Phase II study in more than 550 patients with major depressive disorder, F2695 demonstrated statistically significant improvement compared to placebo on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale ("MADRS"). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale ("HAMD-17") and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment.
Posted on December 23, 2008 @ 08:39 am
Kerri Schoedel, Ph.D. has been promoted to scientific director, clinical pharmacology for
Kendle's Early Stage unit in Toronto. Dr. Schoedel will provide overall scientific direction and leadership to the clinical pharmacology group, as well as lead strategic planning and policy development as it relates to scientific assessment. She is experienced in the field of psychopharmacology and the assessment of drug abuse liability, and also has experience in pre-clinical and clinical studies and working with regulatory authorities.
“I am thrilled to announce Kerri’s appointment to scientific director, clinical pharmacology,” said Phil Davies, vice president, Early Stage. “We look forward to Kerri's continued contributions and leadership as Kendle further advances its established position as the leading authority in Early Stage psychopharmacology and human abuse liability. This appointment also reinforces our commitment to grow and advance our global Early Stage team and capabilities.”
Dr. Schoedel joined DecisionLine, formerly Ventana Clinical Research Corp. and now part of Kendle, in 2004. She began her career as a research scientist and was promoted to senior research scientist. In these positions, she was responsible for providing scientific input to project teams, assisted with clinical study and protocol design and provided project management for clinical research projects.
Posted on December 22, 2008 @ 07:28 am
Sanofi-Aventis and
Novozymes have signed a development and marketing collaboration for a potential new antibiotic. The drug candidate is an antimicrobial peptide named Plectasin NZ2114 that targets the treatment of severe infections, such as pneumonia and septicaemia, caused by bacteria like Staphylococcus and Streptococcus.
SA has been granted an exclusive worldwide license for the development, registration and commercialization of the drug. The two companies will work to develop and implement commercial-scale manufacturing of the drug substance, with the goal of introducing a recombinant process building on Novozymes' proprietary expression technology.
"Plectasin NZ2114 is the first drug candidate that Novozymes has outlicensed for further preclinical and clinical development. Teaming up with one of the largest pharmaceutical companies in the world is the type of collaborations we were looking for," said Per Falholt, executive vice president, R&D, Novozymes.
"The innovative mechanism of action of Plectasin NZ2114 makes it potentially active against bacteria resistant to currently available treatments. We are looking forward to developing Plectasin NZ2114 for the treatment of severe infections such as pneumonia, septicaemia, and complicated skin and soft tissue infections," said Dr. Marc Cluzel, senior vice president, R&D, Sanofi-Aventis.
Posted on December 22, 2008 @ 06:49 am
AstraZeneca and
MAP Pharmaceuticals have formed an exclusive worldwide agreement to develop and commercialize Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulized formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for pediatric asthma and is currently in Phase III. UDB has the potential to be nebulized more quickly and at a lower nominal dose than the commercially available product.
AZ will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the currently ongoing Phase III study. MAP is also eligible to receive as much as $240 million in other potential development and regulatory milestones, as well as additional progressively demanding sales performance-related milestone payments of as much as $585 million in the event the product is a "considerable commercial success," according to an AZ statement.
MAP and AZ will develop UDB in the U.S. and AZ has rights to develop and commercialize UDB outside of the U.S. MAP is eligible to receive significant double-digit royalty payments on net sales of UDB worldwide, and AZ will support and fund the establishment of a MAP sales force to co-promote UDB in the U.S. for a certain period of time after product launch.
AZ will be responsible for future UDB development costs and will reimburse MAP for the costs of future UDB development activities with respect to U.S. registration.
David Brennan, AZ's chief executive officer, remarked, “MAP Pharmaceuticals’ advancement in UDB represents an important potential new option for treating children confronting asthma. AstraZeneca’s heritage in treating pediatric asthma, combined with MAP’s expertise can open new areas of opportunity for both companies and has the potential to bring significant medical benefit to the wider community.”
UDB is being developed utilising a license to
Elan's proprietary NanoCrystal Technology. The small size and stability of NanoCrystal drug particles are designed to enable improved delivery efficiency of drug formulations to the lung via nebulization, according to AZ.
Posted on December 22, 2008 @ 06:43 am
Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking approval for treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA contains data from six Phase III trials involving more than 11,000 patients, according to Amgen.
"Two Phase III pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce fracture, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "This submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies."
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.
Posted on December 19, 2008 @ 06:56 am
PharmaNet Development Group is working with a financial advisor to pursue strategic alternatives, including the potential sale of the company. “The Board of Directors and management believe that pursuing strategic alternatives will maximize shareholder value,” commented Jeffrey P. McMullen, president and chief executive officer. “I strongly believe this approach will provide a more positive outcome for our clients and employees.”
As part of the process, the company recently received several confidential, non-binding written expressions of interest from a number of parties, none of whom are direct competitors, according to a company statement. The company does not intend to comment further on the strategic alternative process unless or until a definitive agreement has been reached or the Company changes its strategic direction. UBS Investment Bank is working as its financial advisor.
Posted on December 19, 2008 @ 06:53 am
Oncothyreon Inc. has announced plans to restructure and focus on development of two compounds, PX-478 and PX-866. PX-478 is an inhibitor of hypoxia inducible factor-1 alpha that is currently in a Phase I trial for advanced metastatic cancer and lymphoma. PX-866 is an inhibitor of PI-3 kinase that is also in a Phase I trial in patients with advanced cancer.
The company will reduce the size of its workforce and its senior management team. Approximately eight employees in its Edmonton facility, primarily engaged in preclinical work and administrative functions, will be fired. In addition, Edward Taylor, vice president and chief financial officer, and Rao Koganty, Ph.D., vice president and head of Synthetic Biologics, will be retiring, effective December 31, 2008. The resignation of Lynn Kirkpatrick, Ph.D., as chief scientific officer effective December 31, was previously announced. Oncothyreon also intends to close its Tucson facility in 2009 and to transfer to Seattle or outsource activities in support of PX-478 and PX-866 that are currently conducted in Tucson.
In addition, Oncothyreon has sold responsibility for the manufacture of Stimuvax to
Merck KGaA. Merck and its EMD Serono Canada subsidiary have purchased current inventory and certain assets utilized for the manufacture of Stimuvax for net payments of approximate $13 million. As part of the transaction Merck KGaA has assumed control of Oncothyreon's Edmonton, Canada facility, which is primarily utilized for the manufacture and development of Stimuvax.
EMD Serono Canada intends to offer employment to the majority of Oncothyreon's 52 employees in Edmonton. In addition, Merck KGaA will be responsible for all further development costs related to Stimuvax, including commercial-scale manufacturing process development, and for the cost of goods at commercialization. The royalty rates payable to Oncothyreon on future net sales of Stimuvax, if any, have been adjusted to reflect that Oncothyreon is no longer responsible for these costs. Potential payments upon achievement of certain milestones under the previous agreements between Merck KGaA and Oncothyreon remain unchanged.
Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a glycoprotein antigen widely expressed on common cancers. It is currently in Phase III.
"We believe that an intense focus on these exciting product candidates is the best means to create value with our available resources," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "We currently expect to complete the Phase I trials for each of these products and, if the data are supportive, to move each of them into Phase I trials in 2009. We believe the approximately $13 we received from the sale of manufacturing rights for Stimuvax and certain assets to Merck KGaA, together with existing cash, will be sufficient to fund these objectives."
With the payments from the sale of manufacturing rights for Stimuvax and current inventory and certain assets to Merck KGaA, together with existing cash, the company has sufficient cash resources to fund operations into the first quarter of 2010, according to a company statement
Posted on December 18, 2008 @ 06:24 am
Wyeth has acquired
Thiakis Limited, a privately held biotechnology company based in the United Kingdom. Thiakis' lead product candidate, TKS1225, is being studied for the treatment of medical obesity and other co-morbidities. TKS1225 and related compounds are synthetic versions of the natural gastrointestinal peptide oxyntomodulin.
Wyeth is paying approximately $30 million for Thiakis, with potential milestone payments of as much as $120 million. Thiakis was founded in 2004.
"This acquisition is evidence of our commitment to develop and bring to market innovative, high-value medicines that have the potential to address significant unmet needs in critical therapeutic areas such as metabolic disorders," said Mikael Dolsten, M.D., Ph.D., president, Wyeth Research. "Thiakis' R&D program fits well with our goal of addressing the medical burden of obesity in a targeted manner using biologic-based therapies."
"As we take this important step with Wyeth, we are certain we have chosen the right company to follow through on our vision and commitment to develop and commercialize important new therapies that help address the growing worldwide medical epidemic of obesity," says John Burt, D.Phil. ACMA, chief executive officer and co-founder of Thiakis.
Posted on December 18, 2008 @ 05:17 am
GlaxoSmithKline has signed a license agreement with
DSM Biologics and
Crucell, allowing GSK to research a recombinant protein on the PER.C6 platform. Financial terms of the agreement were not disclosed.
"We are very pleased to enter into this collaboration with GSK," said Ronald Brus, Crucell's chief executive officer. "This agreement further underscores the potential of our PER.C6 production technology for generating recombinant proteins."
"The PER.C6 production technology continues to surpass our expectations as a robust manufacturing platform with its ever extending and global reach into the Research and Development departments of major healthcare players," Karen King, president of DSM Biologics, commented. "This agreement with GSK brings us closer to our mission of making the PER.C6 technology a gold standard for industry use."
Posted on December 18, 2008 @ 05:15 am
Auxilium Pharmaceuticals and
Pfizer have entered into a strategic alliance for the development, commercialization and supply of Xiaflex, a novel, first-in-class, biologic for the treatment of Dupuytren's contracture and Peyronie's disease. Pfizer will receive exclusive rights to commercialize Xiaflex in the 27 member countries of the EU and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for Xiaflex in these countries.
Pfizer will make an up-front payment of $75 million to Auxilium and as much as $410 million in milestone payments, with $150 million tied to regulatory milestones and $260 million based on sales milestones. Auxilium will receive increasing tiered royalties based on sales of Xiaflex in Pfizer's territories.
Auxilium will remain primarily responsible for the global development of Xiaflex and will be responsible for all clinical and commercial drug manufacturing and supply. Pfizer will share clinical development costs for certain trials required for the EU and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex. Pfizer will have a right of negotiation to obtain exclusive rights to commercialize Xiaflex pipeline indications in its territories.
Auxilium has completed Phase III trials for Xiaflex in Dupuytren's contracture and expects to file a biologics license application (BLA) in the U.S. for the treatment of Dupuytren's contracture in early 2009. Pfizer expects to file Xiaflex for approval for the treatment of Dupuytren's contracture in Europe in 2010. Xiaflex is also being evaluated in a Phase IIb trial for Peyronie's disease, with top-line data expected in late 2009.
"Today, Pfizer and Auxilium have forged a compelling partnership and together we believe we have the opportunity to offer the first, effective non-surgical treatment for two diseases," said Armando Anido, chief executive officer and president of Auxilium. "With the strength of Pfizer's commercialization and development organization, this relationship greatly enhances our ability to effectively introduce this potentially groundbreaking technology for the treatment of Dupuytren's contracture and Peyronie's disease in Europe."
Posted on December 17, 2008 @ 07:19 am
Covance has purchased a minority equity stake in
Caprion Proteomics, a provider of proteomics-based services. Covance has also hired a new vice president to lead its Biomarker team and that it plans to establish a Biomarker Center of Excellence at its Greenfield, IN campus.
These moves are intended to enable Covance to capitalize on the emerging high-growth service market in biomarker discovery, verification, validation, and deployment across the drug development continuum, from preclinical to post-marketing surveillance.
Covance will serve as the exclusive CRO distributor of Caprion's proteomic biomarker services. In addition, Caprion will serve as Covance's exclusive proteomic discovery provider. Through this alliance, Covance and Caprion will offer pharmaceutical and biotechnology drug development customers a "distinctive, innovative, and integrated biomarker solution," according to a Covance statement.
"We are very pleased to be adding Caprion's solid scientific capabilities and leading biomarker technology platform to Covance's line up," said Deborah Tanner, corporate senior vice president and president of Covance Central Laboratory Services. "We expect that our clients will have a keen interest in this additional capability given Caprion's impressive track record of accelerating biomarker validation for early drug safety and efficacy assessment."
"We are excited to join forces with Covance's market-leading central laboratory and world-class scientific talent," said Martin LeBlanc, president and chief executive officer of Caprion. "Over the past five years, Caprion has established a large pharmaceutical customer base through employing our distinctive, best-in-class technology platform, which we expect will be further adopted in the market as a result of our alliance with Covance. Most importantly, we believe this alliance, which combines Covance's leading research services platform with Caprion's leading biomarker platform, will yield superior biomarker solutions for our clients."
Covance's Biomarker Center of Excellence will focus specifically on biomarker testing and validation and leverage the discovery support services of Caprion and of the services that already reside at Greenfield, including in vivo preclinical safety and efficacy assessment, and a variety of sophisticated preclinical imaging modalities.
The biomarker business will be led by
Thomas Turi, Ph.D., Covance's new vice president of Biomarkers. In his new role, Dr. Turi will be responsible for building the Center of Excellence for Biomarkers leading the Biomarker Expert Team.
Dr. Turi joins Covance with more than 14 years of experience leading drug discovery projects ranging from exploratory through early development programs. Prior to Covance, Dr. Turi spent his career at Pfizer, where he held a broad array of scientific leadership positions of increasing responsibility. Most recently, Dr. Turi served as the senior director of Translational Biomarkers and Mechanistic Biology at Pfizer's laboratories in Groton, CT.
Posted on December 17, 2008 @ 07:12 am
GlaxoSmithKline and
Dynavax Technologies have entered a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases.
Dynavax will receive an initial payment of $10 million and GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. Dynavax’s lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.
“Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax,” commented Dino Dina, M.D., president and chief executive officer of Dynavax. “Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our stockholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programs.”
Dynavax will conduct research and early clinical development in as many as four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered royalties on sales and has retained an option to co-develop and co-promote one specified product.
Posted on December 17, 2008 @ 07:09 am
PPD, Inc. plans to expand its global central lab services into Singapore in response to growing demand in Southeast Asia. The lab is expected to begin operations in mid-2009 and will provide biopharmaceutical clients with a "comprehensive range of highly customized lab services," according to a PPD statement.
"Southeast Asia is an attractive region for conducting clinical trials, and Singapore is an important biopharmaceutical hub," said Agostino L. Fede, Ph.D., senior vice president of PPD and head of PPD's global central labs. "Establishing a direct lab presence in Singapore will enhance our abilities to reduce turnaround time and deliver high quality specimens and laboratory results at better logistics costs for our clients."
PPD has provided a range of clinical development services in Singapore for several years, including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs. The equipment in Singapore is identical to platforms located at PPD's global central labs in Brussels, Belgium;, Highland Heights, KY, and Beijing, China. Assays will be extensively cross validated among PPD's locations to produce combinable data, according to the company.
PPD's Singapore lab will interface directly with ConneXion, the company's proprietary global computer system, to ensure consistent management and real-time reporting.
Posted on December 16, 2008 @ 08:56 am
Quotient Bioscience Group Ltd. has acquired
Pharmaceutical Profiles Group (PPG), which will be integrated into Quotient Bioresearch. Founded in 1990, Pharmaceutical Profiles is a provider of Phase I drug development services to the global pharmaceutical and biotechnology industries. It offers an integrated formulation development, manufacturing and clinical testing platform incorporating a range of technologies, and covers the development of optimized oral, intravenous, and inhaled clinical dosage forms. It is based in Nottingham, UK and has 75 employees. The company will change its name to Quotient Bioresearch in the next year.
Its addition to Quotient's unit will give the bioresearch business an "integrated metabolic sciences service offering, spanning radio synthesis through to human AME studies," according to a Quotient statement. It will also continue to build on PPG’s position in accelerated clinical formulation development. Mark Egerton will retain his role as managing director of Pharmaceutical Profiles, which will continue to operate from its existing Nottingham Phase I facility.
Pharmaceutical Profiles represents the fifth acquisition to date for Quotient, which was established in early 2007. The enlarged group will have revenues approaching $60 million and employ more than 450 people in the UK. Quotient will continue to operate from its existing sites in Newmarket, Rushden, Nottingham, Edinburgh and London.
Paul Cowan, chairman and chief executive officer of Quotient, said, “We are delighted to have completed the acquisition of Pharmaceutical Profiles. It brings with it a world-class reputation and an innovative service offering, which we plan to expand. It fits extremely well with our strategy of adding complementary drug development capabilities to the existing service offering of Quotient Bioresearch.”
Posted on December 16, 2008 @ 07:21 am
Jazz Pharmaceuticals has fired 71 employees (24% of its work force) to lower operating expenses. The company expects to record a charge of approximately $1.9 million in 4Q08 related to the move. Separately, the company's chief financial officer, Matt Fust, has decided to leave the company at year end to pursue other professional interests. His responsibilities will be assumed by other members of the executive management team.
The reduction does not affect the company's sales force. Jazz currently markets and sells Xyrem and Luvox CR. The company will continue development of JZP-6 (sodium oxybate) for the treatment of fibromyalgia syndrome. The company recently announced positive top-line results from the first of two Phase III clinical trials of JZP-6. JZP-8, Jazz Pharmaceuticals' product candidate providing intranasal delivery of clonazepam for the treatment of acute repetitive seizures, is continuing in Phase II.
"Concentrating our company's efforts on growing sales of our commercial products and pursuing selected development programs, while streamlining our operations, will reduce ongoing operating expenses and minimize the need for additional financing," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "We thank all of our employees for their hard work on behalf of the company and their efforts to help us provide important products for patients and physicians. In particular, I would like to thank Matt for his many contributions since the formation of the company."
Posted on December 16, 2008 @ 07:18 am
The FDA has approved
Abbott's Trilipix delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TRILIPIX has not been shown to prevent heart disease or heart attack, according to an Abbott statement.
"Only 35% of patients with lipid problems are currently being treated with lipid therapies and many are not reaching treatment targets for all three key lipids," said Michael Davidson, M.D., clinical professor and director of Preventive Cardiology, University of Chicago Pritzker School of Medicine. "The approval of Trilipix is good news for patients because now there is a new treatment option that can be used alone or in combination with a statin to help address lipid problems."
Trilipix was studied in 2,698 patients with mixed dyslipidemia, a disorder of all three key lipids affecting millions of American adults. In the studies, mixed dyslipidemia was characterized by elevated LDL (bad cholesterol) and triglycerides (a type of fat found in the blood) and low HDL (good cholesterol). These studies demonstrated that Trilipix used in combination with the most commonly prescribed statins helped patients manage all three key lipids better than the corresponding therapies alone.
Posted on December 15, 2008 @ 08:46 am
AAIPharma and
Cortria Corp. have signed a deal granting Cortria the right to use AAIPharma’s proprietary, controlled release oral drug delivery technology known as ProCR in conjunction with Cortria's TRIA-662 drug candidate.
ProCR is a novel controlled-release technology developed by AAIPharma for use with orally administered drug products. TRIA-662 is Cortria's lead drug candidate, currently in Phase II clinical development for dyslipidemia. In preliminary human studies, TRIA-662 has shown the potential to provide the benefits for niacin therapy without causing skin flushing, a common, use-limiting side effect of niacin agents.
"We believe TRIA-662 is one of the most exciting drug candidates in the cardiovascular pipeline today and we are pleased to work with Cortria to help develop this product candidate for patients with dyslipidemia," said Lee Karras, senior vice president of Global Pharmaceutical Services at AAIPharma. “Our goal is to work with companies like Cortria who have best-in-class therapeutic candidates and who can further benefit from best-in-class oral drug delivery solutions to maximize therapeutic performance.”
“AAIPharma has a rich history of providing oral solid dosage formulation development and has already been an outstanding partner for CORTRIA in the area of analytical services,” commented Daniel Grau, chief executive officer and vice chairman of Cortria. “Through this new agreement, we look forward to expanding our relationship with AAIPharma by applying its ProCR™ technology in the development of commercial formulations of TRIA-662.”
Terms of the license agreement have not been disclosed.
Posted on December 15, 2008 @ 07:11 am
The FDA has granted
Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterferon in combination with ribavirin for treating pediatric hepatitis C. It is estimated that approximately 130,000 children in the U.S. are infected with the hepatitis C virus (HCV); the most common mode of HCV infection for pediatric patients today is maternal-infant transmission.
The only previously approved therapy in the U.S. for treating pediatric hepatitis C is SP's conventional interferon Intron A in combination with Rebetol. Rebetol is available both as capsules and in an oral solution formulation specifically available for pediatric use.
"With the FDA approval of PEGintron combination therapy for this new indication, U.S. physicians now have access to the current standard of care for hepatitis C for use in treating their pediatric patients. Thankfully, the number of children with hepatitis C is small, although this chronic infection over time can lead to serious liver disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This approval further underscores Schering-Plough's leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C."
The approval of PEGINTRON for the pediatric indication is based on the results of a clinical trial in 107 previously untreated patients three to 17 years of age with chronic hepatitis C and compensated liver disease.
Weight loss and growth inhibition were common side effects in the trial, and some children who experienced growth inhibition during therapy still had inhibited growth velocity 6 months following the end of treatment. Most common adverse reactions (more than 25%) observed in these studies were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. Three percent were treated for clinical hypothyroidism.
Posted on December 12, 2008 @ 06:21 am
Patheon 4Q08 (ended 10/08)
4Q Revenues: $172 million (+6%)
4Q Earnings: $37 million (loss of $7.5 million in 4Q07)
FY Revenues: $717 million (+13%)
FY Loss: $1.4 million (loss of $94.6 million in FY07)
Comments: Commercial manufacturing revenues increased 11% for the year to $577.7 million, reflecting growth in European, Canadian and Puerto Rican operations. Pharmaceutical Development Services revenues grew 20% to $139.5 million. After the fiscal year ended, Patheon chose to shut down operations in Carolina, PR, contending that the cost savings outweighed the uncertainty of a sale. Severance costs related to this move are expected to be $3 million in 1Q09. Chief executive officer Wes Wheeler contended that this will be the last major restructuring step for Patheon.
Posted on December 12, 2008 @ 06:04 am
Bristol-Myers Squibb and
Exelixis have entered a global collaboration covering two novel anti-cancer molecules. Bristol-Myers Squibb agreed to pay Exelixis an upfront cash payment of $195 million for the development and commercialization rights to two Exelixis molecules: XL184, a small molecule inhibitor of MET, VEGFR2 and RET, which is currently in Phase III development for medullary thyroid cancer, and XL281, a small molecule inhibitor of RAF kinase, which is currently in Phase I development for the treatment of patients with advanced solid tumor malignancies. BMS will make additional license payments of $45 million in 2009.
The companies have agreed to co-develop XL184. Exelixis will have the option to co-promote XL184 in the U.S. The companies will share worldwide development costs and commercial profits on XL184 in the U.S. Exelixis will be eligible to receive sales performance milestones of as much as $150 million and double-digit royalties on sales outside the U.S.
The clinical development of XL184 will be directed by a joint committee. It is anticipated that Exelixis will conduct a significant portion of clinical development activities through 2010. Exelixis may opt out of the co-development of XL184, in which case Exelixis would instead be eligible to receive development and regulatory milestones of as much as $295 million, double-digit royalties on XL184 product sales worldwide, and sales performance milestones.
BMS will receive an exclusive worldwide license to develop and commercialize XL281 and will be responsible for funding all future development. Exelixis is eligible for development and regulatory milestones of as much as $315 million, sales performance milestones of as much as $150 million and double-digit royalties on worldwide sales of XL281.
“For nearly a decade, the foundation for our close collaborations with Exelixis has been a commitment to discover and develop new medicines to help patients prevail over serious disease,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, R&D at BMS. “XL184 and XL281 represent significant new opportunities to inhibit the progression of many different tumor types. This agreement represents the next pearl in our on-going String of Pearls initiative, designed to accelerate our company’s strategy to transform into a biopharma leader by blending external scientific innovation with our own internal research and development expertise. Together with Exelixis, we intend to fully explore how these compounds can potentially extend the treatment options of patients with cancer."
“There have been many attempts to blend the best of big pharma with the best of biotech, and over the years Exelixis and BMS have learned how to do just that. This new collaboration maximizes the capabilities and strengths of each partner and sets the stage for the aggressive development of XL184 and XL281. The collaboration provides the development programs with appropriate resources and positions both compounds to be developed to their full potential in indications with significant commercial potential,” said George Scangos, president and chief executive officer of Exelixis.
Posted on December 12, 2008 @ 05:56 am
Elan Corp. will realign itself to focus more resources on its pipeline. Concrete plans have not been released, but the company plans to cut a number of positions and "additional refinement to Elan’s commercial activities in Tysabri for Crohn’s disease," according to a company statement. Elan will close its offices in New York and Tokyo during the 1Q09.
Elan's chief executive officer Kelly Martin said that the changes have been under evaluation for several months, remarking, “We continually evaluate our pipeline, product portfolio, and company structure with a goal of maintaining our flexibility and ability to invest in the most valuable product opportunities for patients while driving value for our shareholders.”
Elan president Carlos V. Paya, M.D., Ph.D., said that Elan will shift its effort from what is a traditional sales commercial model to a model based on clinical support and education. He added, “We will continue providing the appropriate clinical information and scientific data to support the key gastroenterologist relationships we have established in the U.S. Elan continues to believe Tysabri is an important therapeutic option for patients with moderately to severely active Crohn’s disease for whom conventional CD therapies and anti-TNFs are not viable.”
Posted on December 11, 2008 @ 05:45 am
Hovione has agreed to acquire
Pfizer's Loughbeg Active Pharmaceutical Ingredients (API) site in Cork, Ireland. This site manufactures intermediates for Lipitor's API. The deal is scheduled to be completed by early April 2009. Hovione Cork will employ 70-80 staff. During the next two years, Hovione will transfer in products from its Loures, Portugal site and validate processes for new compounds in expectation of drug approval. The terms of the transaction were not disclosed but Hovione will continue to provide manufacturing services for Pfizer.
The plant is multi-purpose and is able to address a large number of specialized chemistries such as hydrogenation and low temperature chemistry. The Cork site also provides Hovione with a new, $85 million capability to produce spray-dried formulations.
The site has had a number of owners, starting in 1984 with Angus Fine Chemicals, then Hickson & Welch, Warner Lambert, Pfizer and now Hovione. In the last 10 years Pfizer has invested several hundred million dollars in plant and equipment there, making it a modern, well equipped site, meeting the highest standards in the industry, according to a Hovione statement.
"We made clinical trial materials for more than 40 drug candidates last year. We have been investing heavily in R&D for more than six years and now have a strong development pipeline but have not invested in manufacturing assets since 2001, so it was time that we expanded our manufacturing capacity," said said Miguel Calado, Hovione's chief financial officer. "This site offers everything that our customers might want: large scale capacity, the highest standards, in a location where tax benefits are available to them and a well trained, innovative workforce."
Discussing the decision to invest in Ireland when many analysts point to China as the trend of the future, Hovione chief executive officer Guy Villax remarked, "We have been manufacturing in China for over 25 years — we know very well what China can do for the Pharma industry, but we also know what it can't do — and it is for those reasons that we are now in Cork. The Cork site, the New Jersey Technology Transfer Centre, Loures in Portugal and Taizhou and Macau in China now provide Hovione with the right range of capabilities in the correct geographies - every site meets FDA requirements for APIs but every site is suited to a different and well defined mission."
Posted on December 11, 2008 @ 05:36 am
Joern Aldag will resign from his position as president & chief executive officer of
Evotec, effective December 31, 2008.
Dr. Mario Polywka, chief operating officer, and
Dr. Klaus Maleck, chief financial officer, will jointly lead the Company until a permanent successor is announced.
Dr. Flemming Ornskov, Evotec's chairman, said, "During his 11-year tenure, Joern Aldag played a pivotal role in the transformation of Evotec from a technology provider to an integrated, CNS-focused biopharmaceutical company. Today the company has a very strong financial position and a deep preclinical and clinical pipeline of CNS drug candidates that provide a strong basis for future success. On behalf of the Evotec board, I would like to thank Joern Aldag for his effective and very successful leadership of the Company and we wish him ongoing success for his future endeavors."
Posted on December 11, 2008 @ 05:35 am
Helsinn Birex Pharmaceuticals,
Helsinn's drug product manufacturing facility in Dublin, Ireland, recently obtained authorization for Manufacture of Investigational Medicinal Products (IMP) for products for human use from the Irish Medicines Board according to EU Directive 2001/20/EC.
The IMP licence enables Helsinn Birex Pharmaceuticals to package, test, store and release of material for use in clinical trials. "Having this authorization expands the range of development activities we can manage within the company and can offer as a service to our partners and confirms again the company's advanced quality systems and technical capabilities," said Helsinn's chief operations officer, Dr. Giorgio Calderari.
Since 2007 the company has invested in packaging and labelling equipment and facilities to enable it to do both primary and secondary packaging of such products. In the future these activities can be managed directly by Helsinn, giving the company better cost control and ability to react to last-minute changes, according to a company statement.
The first packaging run has been completed for a study involving the Groups lead compound Palonosetron (ALOXI, ONICIT). Obtaining the IMP licence, follows on from the successful inspection of Helsinn Birex Pharmaceuticals by the FDA earlier this year.
Posted on December 10, 2008 @ 08:37 am
Almac Clinical Services completed a successful inspection of its Durham, NC operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This marked the final inspection covering the group’s main sites for clinical supplies and follows inspections performed at the Craigavon, UK and Audubon, PA facilities within the last four months.
The voluntary inspection, which occurred in November 2008, observed that the Durham site was fully compliant with EU GMPs, with no critical or major failures noted, according to an Almac statement.
Paul O’Connor, vice president, quality at Almac Clinical Services, commented, “The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company-wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections. I would like to thank all of our staff for their hard work towards achieving this success.”
Robert Dunlop, the group's president, added, “Congratulations to all staff across our three sites who have put significant effort into the design and implementation of our quality systems. This result gives our client base an assurance of high standards and consistency across all of our operational sites. Quality is one of Almac’s core values and we use the strength of our systems, facilities and people to differentiate ourselves in the marketplace.”
Posted on December 10, 2008 @ 08:30 am
Patheon has opened its new U.S. headquarters and analytical lab facilities in the vicinity of Research Triangle Park (RTP), NC. The new pharmaceutical development laboratory will support Patheon's current U.S.-based pharmaceutical development operations in Cincinnati and will initially offer stability studies, validation testing and analytical chemistry services.
Wes Wheeler, chief executive officer and president of Patheon Inc., remarked, "North Carolina is a rapidly growing center for the pharmaceutical industry, which now boasts 334 biotechnology-related companies. It is a pro-business community which combines attractive corporate incentives with a high quality of life for our employees. We are delighted to open our new U.S. headquarters and our new laboratory here, in the vicinity of Research Triangle Park."
The company recently announced that JLL Patheon Holdings, a holding company of private equity investors JLL Partners, is considering a bid to take Patheon private.
Posted on December 10, 2008 @ 07:23 am
Valeant Pharmaceuticals has signed a definitive agreement to acquire
Dow Pharmaceutical Sciences (DPS), Inc. According to a Valeant statement, the transaction will boost Valeant's dermatology franchise in the U.S. through the acquisition of a specialized dermatology R&D organization, including a newly approved product and a robust pipeline of five dermatology products, three of which are in Phase II clinical development.
Valeant will pay Dow $285 million, subject to certain closing adjustments. Approximately $8 million in cash will be retained from current Dow accounts, making the net amount paid $277 million. In addition, there are commercialization milestones that may ultimately raise the price of the acquisition. DPS' current annualized revenues are approximately $45 million, of which approximately $20 million represents royalty payments from products already out-licensed by DPS.
DPS recently received approval from the FDA for Acanya, a novel topical prescription medication indicated for the treatment of mild to moderate acne. Acanya is expected to be launched in the U.S. in early 2009. Dow has products in clinical development for the treatment of rosacea, moderate to severe acne, fungal infections and common warts. Valeant anticipates at least one DPS product will enter Phase III in 2009, with a product launch possible by 2012. In addition, DPS operates a topical products services business dedicated to working with external sponsors for the formulation and development of topical therapies.
"This acquisition grows our scale and capabilities in dermatology, thus solidifying Valeant's future as a leading company in the development and commercialization of dermatology medications," stated J. Michael Pearson, chairman and chief executive officer of Valeant. "Gordon Dow, the founder of Dow Pharmaceutical Sciences, and his team are highly regarded with innovative formulation and development expertise, exemplified by having worked on 10 dermatology approvals from the FDA in the past few years and with projects underway in eight of the top 10 dermatology diagnoses. We are excited that they will be joining the Valeant team as we believe the synergies between our newly acquired Coria franchise and Dow's business will provide sustainable growth for many years to come."
Posted on December 9, 2008 @ 07:18 am
Merck Serono, a division of Merck KGaA, has received marketing authorization from the European Commission for Kuvan for the treatment of hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients. Kuvan, which had previously received Orphan Medicinal Product designation from the European Medicines Evaluation Agency (EMEA), is the first drug approved in Europe for HPA due to PKU or BH4 deficiency.
"To date, there has been no drug treatment available in Europe for patients suffering from PKU, a debilitating inherited condition that can cause serious brain damage in children and transient to lasting impairments in adults if a strict diet is not observed throughout life," said Roberto Gradnik, executive vice president Commercial Europe at Merck Serono. "With the approval of Kuvan, Merck Serono provides patients access to an efficient treatment to better control their blood phenylalanine levels. This will contribute to improving their quality of life and may ultimately reduce the risk of lasting mental impairment."
There are approximately 35,000 patients diagnosed with hyperphenylalaninemia due to PKU or BH4 deficiency in the EU. PKU and BH4 deficiency are rare diseases caused by genetic defects in the metabolism of the amino acid phenylalanine (PKU), or in the enzymes responsible for the recycling and synthesis of the cofactor BH4 (BH4 deficiency), resulting in hyperphenylalaninemia, i.e. abnormally high levels of phenylalanine in the blood. Hyperphenylalaninemia can cause serious brain damage in infants and children, and transient to lasting neurocognitive impairment in adult patients.
Previously, the only therapy option for PKU patients in Europe to manage their disease was through a diet highly restricted in phenylalanine (food with high levels of phenylalanine include meat, fish, nuts, dairy products and some vegetable and fruits) associated with daily amino-acid supplementation. Non-adherence to the restrictive diet and adequate control of blood phenylalanine levels can result in a decline in mental and behavioral performance.
The marketing authorization is supported by data from two international, double-blind, randomized, placebo-controlled Phase III clinical trials in patients with hyperphenylalaninemia due to PKU. The data show that treatment with Kuvan reduces blood phenylalanine levels and increases the proportion of patients with blood phenylalanine levels within target range, resulting in a higher dietary phenylalanine tolerance, which may reduce the need to limit phenylalanine intake in patients' diet.
As an Orphan Medicinal Product and the first drug approved for the treatment of HPA, Kuvan will receive 10 years of data protection in the European Union for this therapeutic indication. Launch of Kuvan in Europe is expected to start in the first half of 2009.
Posted on December 9, 2008 @ 07:10 am
Parexel International has established an alliance with Safe Implementation of Treatments in Stroke (SITS) International, the world's largest network of clinical sites with specialized capabilities in the area of stroke. Through this alliance, Parexel's clients can benefit from SITS' access to investigator sites that are dedicated to the treatment of patients suffering from acute stroke and to the conduct of Phase II - IV stroke-related clinical studies.
"In joining forces with Parexel, SITS looks forward to furthering the growing field of stroke research and speeding the introduction of important treatments to patients," said Nils Wahlgren, M.D., Ph.D., chairman of SITS International. "We look forward to working with Parexel to implement stroke programs throughout our expanding network of sites." The SITS network currently comprises more than 800 investigator sites in 40 countries.
Said Mark A. Goldberg, M.D., chief operating officer, Parexel, "Our alliance with SITS is representative of our dedication to providing clients with expanded capabilities in the area of stroke, including accelerated study start-up and patient recruitment for clinical development programs. We are pleased to combine our in-depth central nervous system therapeutic area expertise with the highly specialized capabilities of SITS to help clients execute stroke-related studies more efficiently on a global basis."
Posted on December 9, 2008 @ 07:05 am
Ben Venue Laboratories has received the 2008 Governor's Award for Outstanding Achievement in Environmental Stewardship. Presented by Governor Ted Strickland (D-OH) and the State of Ohio Environmental Protection Agency, the award recognizes Ben Venue for its environmental, health and safety management system that "strives to promote a safe and healthy manufacturing environment, including brownfield reuse and re-development, LEED (Leadership in Energy and Environmental Design) construction design and application for Silver Certification for its recently completed 90,000 square foot Lab and Office facility, recycling and reuse, energy saving, and water conservation," according to a BV statement.
Coordinated by Ohio's EPA, the award seeks to acknowledge Ohio businesses and organizations demonstrating a commitment to go above and beyond compliance, maintain aggressive environmental performance goals, and provide a process for communicating with others about program activities and progress toward established goals.
Submitted nominations were rated and the Ohio EPA completed site audits with the finalists to select eight honorees. "I'm honored to recognize these forward-thinking award winners, which have all demonstrated cutting-edge achievements and a commitment to environmental stewardship in Ohio," said Ohio EPA director Chris Korleski in a press release issued by the Governor's office.
Posted on December 8, 2008 @ 07:41 am
Roche has dosed the first patient in a Phase I pharmacokinetic trial with a subcutaneous formulation using
Halozyme Therapeutics' Enhanze Technology of a biologic directed to a Roche exclusive target. This has triggered a milestone payment under the collaboration agreement between the two companies.
Roche has also selected an additional exclusive target under the existing license and collaboration agreement. Roche will pay Halozyme for exclusive, global rights for the application of its hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.
"Roche and Halozyme have successfully completed the necessary drug product formulation and preclinical studies required to initiate a clinical trial. Entering the clinic is a significant achievement and demonstrates Roche's strong commitment to a successful partnership," said Jonathan Lim, M.D., Halozyme's president and chief executive officer. "We are very pleased with the progress that is being made through our collaboration. Roche is a global leader in the development of biologics and we are excited that they have selected a fourth exclusive target, in addition to the three already under development, further validating Halozyme's core technology."
Roche has also maintained its rights to other targets covered in the license and collaboration agreement. An aggregate payment of $10.25 million will be made to Halozyme for commencing a Phase I clinical trial, exercising exclusive global rights to a fourth biologic target and for annual maintenance fees.
In addition, Halozyme has entered into a supply agreement with Roche to provide rHuPH20 for use in formulations with biologics directed against Roche targets covered under the licensing and collaboration agreement. Halozyme is continuing scale-up of its manufacturing processes to enhance yields and efficiencies in order to produce multi-kilogram quantities of enzyme. Halozyme will supply rHuPH20 to Roche to fulfill all of its clinical development and commercialization requirements.
Posted on December 8, 2008 @ 07:37 am
Bristol-Myers Squibb and
AstraZeneca have expanded their worldwide collaboration to include the development and commercialization of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.
BMS and AZ entered into a global R&D and commercialization collaboration in January 2007, but it excluded Japan. The companies now have agreed to co-develop dapagliflozin in Japan with AZ covering operational and cost responsibility for all development and regulatory activities on behalf of the collaboration. The two companies will jointly market the product in Japan, sharing all commercialization expenses and activities and splitting profits/losses equally. BMS will manufacture dapagliflozin and also book sales. Dapagliflozin is currently being studied in Phase II clinical trials in that market.
“BMS and AZ have been working together to develop dapagliflozin for type 2 diabetes for nearly two years; this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer, BMS. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than six million people in Japan living with type 2 diabetes.”
“Last year, the cost of treating and preventing type 2 diabetes and its complications in Japan was more than $18.4 billion, which is a significant cost to Japanese society,” said Bruno Angelici, executive vice president, International Sales and Marketing Organization, AZ. “We have a long-standing presence in Japan, and our agreement with BMS to bring a potentially important type 2 diabetes treatment to market in the region will not only help reduce this cost burden, but also reduce the impact this disease has on the country’s health.”
Posted on December 8, 2008 @ 07:33 am
BioMerieux has acquired PML Microbiologicals Inc., a provider of culture media and microbiological products in North America, for nearly $30 million. PML has manufacturing and marketing teams based in Portland, OR and Toronto, Canada.
The acquisition will enable bioMerieux to become a leading provider in the U.S. of microbiology testing solutions for pharmaceutical companies, according to a company statement. In addition, bioMerieux will enter the North American clinical prepared culture media (PPM) market, becoming the top PPM provider for clinical applications in Canada.
Founded in 1969, PML has 205 employees with 2007 sales of $24 million. BioMerieux purchased all of PML's shares from the privately held Pelican Life Sciences Group for $29.6 million. PML has an range of products for use in the clinical and pharmaceutical industries, holding proprietary technologies for innovative culture media. PML specializes in reagents, including prepared culture media for sterility testing and environmental monitoring, as well as control organisms, which are complementary to bioMerieux's offering.
"This new acquisition, our sixth in two years, reinforces the North American market position of bioMerieux's core business, microbiology," declared Stephane Bancel, bioMerieux's chief executive officer. "In the current challenging economic context, we are pleased to add another reagent-only business to our portfolio that will boost bioMerieux's recurring sales."
"The PML acquisition brings to our customers in the pharmaceutical industry an enhanced range of high performance, innovative solutions for the control of their manufacturing environment and products," added Alexandre Merieux, corporate vice president, Industrial Microbiology.
Posted on December 5, 2008 @ 08:20 am
Nigel McBean has been named vice president and director of operations at
IndiPharm's operational headquarters in Mumbai, India. Mr. McBean will be responsible for all operational activities, including identification and recruitment of investigators and clinical research sites, regulatory approvals, project and site management, monitoring, and pharmacovigilance. He will be based in Mumbai and will be responsible for expanding and managing the staff for the India-based operations.
Mr. McBean has experience managing clinical research projects in Asia and the Pacific, ranging in size from 20 patient single-center studies to 5000 plus patient global studies. He has managed global clinical projects in North and South America, Africa, the Middle East and Europe across multiple therapeutic areas including infectious diseases, oncology, cardiovascular, dermatology, urology and immunology.
Mr. McBean was previously the director of Multi-Centre Research for PRACS Institute Ltd. (now part of the Cetero Research Group), where he implemented an electronic clinical management system to support projects from inception to final clinical report. He also developed a clinical database that evaluates potential sites based on investigator details and experience, the facilities and staff, local regulatory turnaround time, recruitment performance, patient demographics, and site availability.
James A. Bannon, IndiPharm’s chairman of the board said, “Western clients will benefit from Nigel’s global clinical trial management experience and his direct leadership of our Indian operations in meeting the project timelines, quality standards and regulatory expectations.” The foundation of the Indian operations is the Indian Investigator Network (IIN), which will be managed by Mr. McBean. The IIN is a network of clinical investigators with extensive experience in multinational clinical trials in a wide range of therapeutic areas.
Posted on December 5, 2008 @ 07:36 am
K. Peony Yu, M.D., has been named vice president, clinical development at
FibroGen. Dr. Yu has expertise in design and execution of all phases of clinical development programs, including clinical and regulatory strategy, interactions with regulatory authorities in the U.S. and EU, as well as experience with successful leadership of clinical teams.
Dr. Yu was most recently vice president, clinical research, at Anesiva, Inc., where she was responsible for management of clinical research, statistics/data management, clinical operations, and medical affairs/medical information for all clinical programs, including the late-stage clinical development and approval of Zingo, a drug-device combination for pain management. Prior to Anesiva, Dr. Yu was director, clinical development, at ALZA Corp. (a subsidiary of Johnson & Johnson) where she was global clinical lead for IONSYS, a drug-device combination for post-operative pain, and led a successful NDA resubmission with the FDA and multiple interactions with European regulatory authorities resulting in marketing approval in 25 European countries. Prior to ALZA, Dr. Yu held previous posts at Pain Therapeutics, Inc. and Elan Pharmaceuticals.
“Peony’s experience in leading multifunctional clinical teams with proven success in advancing investigational products through all stages of clinical development through regulatory approval will be an important asset to FibroGen,” said Frank H. Valone, M.D., chief medical officer of FibroGen. “We look forward to her leadership of our multiple clinical programs in the U.S. and globally.”
Posted on December 5, 2008 @ 07:32 am
Orexigen Therapeutics will cut several programs in order to focus on its obesity drugs, Contrave and Empatic. Proof-of-concept Phase II trials for OREX-003 (zonisamide and olanzapine to mitigate antipsychotic-associated weight gain) and OREX-004 (fluoxetine and naltrexone to reduce symptoms of obsessive-compulsive disorder) have been discontinued. The company will hold onto its intellectual property in these assets and retains the option to restart both programs.
Orexigen is directing all of its efforts and resources to Contrave and Empatic, its obesity product candidates. It anticipates announcing the results from the first Phase III clinical trial for Contrave in January.
Dr. Gary Tollefson has resigned as director, president and chief executive officer, to focus on his continued recovery from a previously disclosed diagnosis of acute leukemia. Chief business officer Anthony McKinney and vice president of neuroscience Frank Bymaster have left Orexigen pursue other opportunities. Dr. Michael Cowley will step down from his role as chief scientific officer, but will consult for the company.
"While our balance sheet remains strong, the company recognizes the challenges of the current economic environment and the need to focus our resources on our late-stage obesity programs," said Eckard Weber, M.D., the company's interim president and chief executive officer and executive chairman. "I would like to thank Gary, along with the other members of the departing group, for their extensive contributions to Orexigen. We believe we are in a very favorable position largely as a result of their efforts."
Posted on December 4, 2008 @ 09:11 am
Elaine Taylor has been named director of research services at
Camargo Pharmaceutical Services. Ms. Taylor will perform all scientific research writing activities and provide full life-cycle support from clinical study protocols through regulatory submission and post approval activities.
Ms. Taylor joins Camargo with more than 20 years of experience in the pharmaceutical industry and research expertise in analytical chemistry, products research, pharmacology, toxicology and clinical studies (Phase I-IV). Her background also includes a thorough understanding of regulatory affairs and requirements of the FDA, European and Canadian authorities.
Prior to joining Camargo, Ms. Taylor held numerous positions at Proctor & Gamble, most recently as the senior medical writer with responsibilities of preparing and writing a variety of documents for Phase I-IV clinical studies.
Posted on December 4, 2008 @ 08:42 am
MedImmune has initiated a Phase II clinical trial in patients with chronic asthma to determine the safety of subcutaneous dosing of MEDI-563 a humanized monoclonal antibody (MAb) that targets the interleukin-5 receptor (IL-5R). Preclinical data suggest that inhibiting the IL-5R pathway may lead to a targeted approach for treating patients with asthma, supporting continued study of this antibody, according to the company.
MEDI-563, which was generated using BioWa's POTELLIGENT Technology platform, has previously been investigated in a Phase I open-label dose-escalating study to evaluate the safety and tolerability of a single intravenous infusion in adults with mild-to-moderate asthma. Data from the completed study demonstrated that the antibody was well-tolerated with biologic activity producing substantial and prolonged depletion of blood eosinophils, thus supporting its continued development.
The antibody is also currently being evaluated in a double-blind, placebo-controlled Phase I study to evaluate the safety and tolerability and effects of the antibody on airway eosinophils in adults with asthma.
"Asthma can be a very debilitating disease, and despite current therapies, patients are in need of novel treatment options," said Nestor Molfino, M.D., vice president, clinical development, pulmonary disease. "Some asthmatics may show an increased circulation of eosinophils in blood -- a certain type of white blood cell believed to play a critical role in the severity and disease pathway of asthma; therefore administration of this antibody may increase asthma control."
Posted on December 4, 2008 @ 08:39 am
Dr. Shoibal Mukherjee has been named senior vice president – Clinical Development, at
GVK Biosciences Pvt. Ltd. William Harel, Ph.D. has been named vice president – Business Development, West Coast USA.
Prior to joining GVK BIO, Dr. Mukherjee served in Ranbaxy and Pfizer in senior positions. He graduated as a physician and is an M.D. and D.M. in Pharmacology. Professionally trained in clinical and pharmaceutical medicine, Dr. Mukherjee has experience in managing clinical trials, medical affairs, clinical data management, and clinical pharmacology. He is the founding president of the Indian Society for Clinical Research and a member of several committees.
“Expanding and enriching our leadership team is critical for GVK BIO’s vision of being a leading life-sciences services company," said D. S. Brar, chairman of GVK BIO. "Dr. Shoibal Mukherjee has extensive experience in managing global clinical trials and will play a pivotal role in the growth of the company’s Development services."
Dr. Harel is responsible for developing the business of clinical research in the U.S. and globally. He has more than 20 years of experience in various companies, including Chiron Corp., AAIPharma and Neeman Medical International.
Posted on December 3, 2008 @ 09:09 am
Isogen, a contract development and manufacturing organization for sterile filling, is launching its new facility in Delaware on January 21. The company will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical lab services and pharmaceutical engineering consulting. The Phase I facility will accommodate GMP vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. The company plans to add to its isolator-based lyophilization capacity later in 2009. According to the company, the facility will enable customers to plan and execute the supply of integrated sterile clinical and small scale commercial launches of single or multiple therapeutics at the same time, while reducing costs and risks associated with other in-house and outsourced alternatives.
“Isogen’s facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply,” said Les Edwards, chief executive officer, Isogen. “Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with current Good Manufacturing Practice (cGMP) standards. At the same time many new pipeline drugs moving into clinical trials require Isogen’s unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards,” Mr. Edwards concluded.
Posted on December 3, 2008 @ 09:06 am
PRA International has entered an agreement with
Frontage Laboratories, Inc., enabling PRA Early Development Services’ U.S. Clinical Pharmacology Center to offer full analytical lab testing services to its Phase I – IV trial services in North America.
Under the collaboration agreement, Frontage Laboratories will offer specialized cGMP/GLP compliant bioanalytical services through PRA. Services also include pharmacokinetic and biostatistical consultancy and data support, including data management, biostatistical and PK/PD analysis, and ICH-compliant report writing. Frontage operates a bioanalytical and biomarker research center in Malvern, PA.
PRA’s facility near Kansas City, MO, runs Phase I and Phase IIa studies with a focus on first in human studies and other complex PK studies. Adding bioanalytical testing services aligns the clinical and lab processes in an effort to save time by avoiding clinical trial delays.
Dr. Wim Tamminga, senior director, PRA Early Development Services commented, “We selected Frontage Laboratories as part of our strategy to offer clients a seamless package consisting of clinical and laboratory services. This service allows us to accelerate Phase I studies and to give sponsors the ability to make better decisions earlier in the drug development process. Frontage is the right partner for this collaboration because they are already a well-established provider of cGMP/GLP compliant testing services. Quality of service, location, and scientific knowledge are what make Frontage Laboratories the best collaborative partner for our bioanalytical services.”
Song Li, chief executive officer, Frontage Laboratories said, “We are delighted that PRA chose Frontage Laboratories to assist in delivering service excellence to all clients and customers across the United States. Our scientific team is recognized industry wide for their expertise in solving complex bioanalytical method development issues quickly and cost effectively, allowing our clients to advance to Phase I studies faster. We look forward to building a collaborative relationship with PRA that not only streamlines project execution but also places a strong emphasis on project management.”
Posted on December 3, 2008 @ 08:59 am
Thomas Davidson, Ph.D., has been appointed director of toxicology and pharmacology,
Ricerca. Dr. Davidson is responsible for the company's study directors, peer review of toxicological reports and ensuring on-time delivery of these reports.
Prior to joining the company, Dr. Davidson was the director of toxicology at Enzon Pharmaceuticals, Inc. in Piscataway, NJ. Prior to Enzon, he served as executive director of drug safety evaluation at Bristol-Myers Squibb in New Brunswick, NJ. Dr. Davidson also held previous roles as the director, associate director and group leader for the department of biologics evaluation at BMS in Syracuse, NY.
“Tom has an extensive background in conducting toxicology and pharmacology studies which will benefit our clients,” said Ian Lennox, chairman and chief executive officer, Ricerca. "Tom Davidson’s addition to Ricerca as director of toxicology represents a significant milestone in our continued growth of toxicology as an essential element of Ricerca's strategy and continued success in meeting or exceeding our clients’ expectations of advancing their preclinical compounds with timely and high quality toxicology study results."
Posted on December 2, 2008 @ 09:12 am
WuXi PharmaTech (Cayman) Inc. will discontinue its U.S. biologics manufacturing operations at its Philadelphia facility as of December 31, 2008, resulting in the elimination of approximately 100 positions. The company plans to expand biologics testing, cell banking and cell therapy services at the facility.
WuXi anticipates biologics manufacturing revenues will be less than 4% of total expected annual revenue in 2008. In 2009, the company expects cost savings of approximately $10 million as a result of the discontinued operations.
Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, said, "WuXi has been fortunate, even in current market conditions, to continue to experience rapid growth in our global business. This growth reflects our reputation for providing high-quality laboratory services to our clients in a cost-efficient manner. With our continued focus on growth and profitability, we are moving to mitigate operating risks in our biologics manufacturing operations, all of which are based in Philadelphia, and are shifting our Philadelphia-based resources to biologics testing and laboratory services, which continue to show strong customer demand. Our biologics testing, cell banking and cell therapy operations in Philadelphia and our St. Paul and Atlanta operations will be unaffected by these actions."
Posted on December 2, 2008 @ 09:10 am
Sparta Systems, Inc. has added two software industry veterans to drive global expansion efforts.
Tom Dalle-Molle, vice president of North American sales, and
Nathan Birtle, vice president of EMEA and APAC sales, will use their enterprise solutions expertise to lead worldwide sales and support for the company’s TrackWise enterprise quality management software.
Prior to joining the company, Mr. Dalle-Molle was vice president of sales for SAP’s Consumer Products Group. Before SAP, Mr. Dalle-Molle was instrumental in building PeopleSoft from a $500 million to a $6 billion company, working in roles such as managing director for the Northeast and general manager of the global accounts business. Mr. Dalle-Molle has more than 30 years of experience in the software industry, having held key positions in sales and marketing at companies such as Primavera and Control Point Solutions.
Mr. Birtle previously served as the European sales director for Zoomix, an enterprise master data management provider. Prior to Zoomix, Mr. Birtle held various executive, sales and marketing positions at Arbortext, IBMUK, and Tivoli Systems.
“As the market leader in enterprise-class quality management, the industry looks to Sparta to produce innovative solutions that drive efficiency and compliance efforts across the global supply chain,” said James E. McGowan, president and chief executive officer, Sparta Systems. “With this in mind, we’ve strategically appointed Tom and Nathan, two stellar software executives, to lead our worldwide sales efforts. The experience these veterans bring to Sparta will position the company for future growth as we continue to address the global quality management and compliance needs of companies around the world.”
Posted on December 2, 2008 @ 09:06 am
NextPharma received a successful FDA Inspection at its Waltrop site in Germany. The inspection covered the company's product development services activities, including technology transfer, analytical method validation and stability testing, and contract manufacturing services, including facility qualification and process validation.
The two-part investigation included pre-approval assessment of data/records against the regulatory submission and compliance of the Quality Management System with the FDA six GMP systems. The inspection also confirmed that the approach to facility qualification and risk management was satisfactory.
Bill Wedlake, chief executive officer, NextPharma Technologies, commented, "We are delighted to have received such a positive result at Waltrop and I’d like to commend the site team and the quality specialists who have contributed to this excellent achievement."
Posted on December 1, 2008 @ 09:15 am
Paladin Labs has entered an agreement with
GSK and Glaxo Group Ltd. under which Paladin will be the exclusive distributor of Dexedrine (dextroamphetamine sulfate) in Canada for three years, after which Paladin has the option to purchase all remaining rights to the product in Canada. GSK will provide certain distribution support services for an interim period. The two companies have also entered a strategic relationship whereby Paladin will have the first right to partner with GSK on a number of products that GSK may choose to license or divest in Canada. Financial terms were not disclosed.
Dexedrine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and in the adjunctive treatment of narcolepsy. According to IMS Canada, the ADHD market in Canada was valued at about $120 million in 2007. Dexedrine sales in 2007 were $14 million.
"This agreement will allow us to add to our portfolio of specialty pharmaceutical products and to build significant critical mass for our organization. Not only will we be adding close to $14 million to our top line next year, but just as importantly, we are establishing a strategic relationship with GSK for potential future transactions like this one," said Jonathan Ross Goodman, president and chief executive officer of Paladin Labs.
"We are very pleased to establish this preferred partner relationship with Paladin owing to their clear history of success in commercializing products like Dexedrine and their record of building win-win relationships with partners," said Paul Lucas, president and chief executive officer of GSK. "Dexedrine has a long history of efficacy and safety in improving the lives of Canadians suffering from ADHD and narcolepsy. In the very capable hands of Paladin, we are confident that it will continue to meet the needs of Canadian patients and their healthcare providers."
Posted on December 1, 2008 @ 09:14 am
Lilly has withdrawn its sNDA from FDA for Cymbalta for the management of chronic pain. Lilly plans to resubmit the application in 1H09, adding recent positive data from a study in chronic osteoarthritis pain of the knee.
Lilly submitted the application in 2Q08 based on three clinical trials: one positive study in chronic osteoarthritis pain of the knee and two studies in chronic low back pain, one positive and one that didn't meet its primary endpoint. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.
"This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application," said John Hayes, M.D., a vice president at Lilly Research Laboratories.
The drug is currently FDA-approved for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.
Posted on December 1, 2008 @ 09:12 am
Vical, Inc. received a $1.0 million milestone payment from
Merck based on Merck's planned initiation of a Phase I trial of an investigational plasmid DNA (pDNA) cancer vaccine. The vaccine is based on Vical's DNA gene delivery technology and encodes human telomerase reverse transcriptase (hTERT), which is the subject of a separate license agreement.
"The breadth of applications for Vical's gene delivery technology continues to grow, and now encompasses vaccine candidates against infectious diseases and cancer, cancer immunotherapies, and gene-based angiogenesis for cardiovascular diseases," said Vijay B. Samant, Vical's president and chief executive officer. "We are pleased that our long-standing partner Merck is expanding to a second clinical-stage evaluation of our technology in the cancer area."
November 2008
Posted on November 26, 2008 @ 08:50 am
Christian Velmer has been appointed president and managing director of
Wyeth Canada, effective November 17, 2008. Mr. Velmer replaces
Arnout Ploos Van Amstel, who has taken a position as senior vice president and general manager, Institutional Business Unit for Wyeth.
"Mr. Velmer brings to his new position an extensive knowledge of pharmaceutical company management. I'm pleased to welcome him aboard and I look forward to the continued progress of the Canadian business under his leadership," said Andreas Krebs, president, Europe/Middle East/Africa and Canada, Wyeth.
Most recently, Mr. Velmer was senior vice president Western Europe for Merck Serono in Frankfurt, Germany where he was responsible for the management of 16 countries across Europe. Prior to joining Merck Serono, Mr. Velmer held various senior executive positions with Johnson & Johnson and Bayer in Europe, Asia Pacific and Latin America.
Posted on November 26, 2008 @ 08:49 am
The FDA has granted
Pfizer's Selzentry (maraviroc) full approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. Selzentry was originally granted accelerated conditional approval in August 2007 based on 24-week data from Phase III studies.
The full approval is based on 48-week data from the MOTIVATE (Maraviroc Plus Optimized Therapy in Viremic Antiretrovial Treatment Experienced Patients) studies. The studies compared the safety and effectiveness of Selzentry plus optimized background therapy to placebo plus optimized background therapy in treatment-experienced CCR5-tropic HIV-1 patients.
Accelerated conditional approval is granted to medicines that provide a therapeutic advantage over existing treatments for serious or life-threatening diseases. The FDA grants full approval status once longer-term safety and efficacy data is established. Once full approval is granted, restrictions that apply to conditionally approved medicines are lifted.
“Selzentry has been on a long journey, from its initial discovery by Pfizer scientists in 2000 to this full FDA approval,” said Dr. Howard Mayer, Pfizer’s executive director, and development team leader for HIV/AIDS. “We are extremely excited with this important milestone in Selzentry’s lifecycle and the potential improvement it may bring to treatment-experienced people living with HIV/AIDS.”
Posted on November 26, 2008 @ 08:45 am
Compugen Ltd. has signed a collaboration agreement with
Merck KGaA, a division of Merck Serono, for CGEN-855, Compugen's novel peptide targeting the FPRL1 G-protein coupled receptor (GPCR). This peptide has demonstrated the potential to treat inflammatory diseases and other indications such as cancer, metabolism and cardiovascular diseases.
Under the agreement, Compugen will conduct additional research and Merck Serono has an option to exclusively license the peptide for worldwide development and commercialization.
“We are very proud to add Merck Serono to the growing list of leading pharma companies with which we have collaborations for the advancement of our product candidates,” said Compugen chief executive officer, Mr. Alex Kotzer. “We are also pleased to be the first Israeli biotech company that has signed an agreement with Merck Serono under the Global Enterprise Partnership program of the Chief Scientist of Israel.”
Posted on November 25, 2008 @ 08:50 am
Roche and
Memory Pharmaceuticals have signed a definitive merger agreement under which Roche will acquire Memory Pharmaceuticals for $50 million in cash. Memory develops drug candidates for the treatment of central nervous system (CNS) disorders such as Alzheimer's disease and schizophrenia. The company's nicotinic alpha-7 agonist drug candidates in these disease areas—currently being developed in partnership with Roche—include: R3487/MEM 3454, in Phase II trials for Alzheimer's disease and schizophrenia; and R4996/MEM 63908, in Phase I for Alzheimer's disease.
"Acquiring Memory Pharmaceuticals will enable Roche to secure the future development of its promising nicotinic alpha-7 agonists," said William Burns, chief executive officer, Division Roche Pharmaceuticals. "The innovative work carried out by the scientists at Memory Pharmaceuticals will be fully integrated into Roche's R&D portfolio with the aim of providing new hope for patients and caregivers affected by devastating diseases such as Alzheimer's."
Jonathan Fleming, chairman of the board of directors of Memory Pharmaceuticals said, "Since founding Memory Pharmaceuticals in 1998, we have focused on developing medicines that could make a real difference to the lives of CNS patients. I am proud of the progress our dedicated team has made and I am confident that Roche's capabilities and experience in the CNS field will enable our research to realize its full potential."
Posted on November 25, 2008 @ 08:48 am
Abraxis BioScience, Inc. has entered into an agreement with
AstraZeneca UK Ltd., under which Abraxis would re-acquire the exclusive rights to market Abraxane (paclitaxel protein-bound particles for injectable suspension) in the U.S. The agreement is subject to approval by the board of directors of Abraxis.
“We believe the time has come to further build our commercialization platform for Abraxane in the U.S.,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. “We have gained much in our collaboration with AstraZeneca and they have done a commendable job in building market share. At the same time as building our sales organization, we will be advancing the development of our pipeline of new nab™ product candidates, and will expand our program of studies to support new indications for Abraxane,” continued Dr. Soon-Shiong.
Abraxis has developed a clinical program in an effort to gain new indications for Abraxane as well as other product candidates using the nab technology platform. This program includes eight Phase III trials, for which five protocols have been reviewed by the FDA for study design, 65 investigator-initiated Phase II trials and 16 Phase I studies. Late stage trials for abraxane include: 1st line lung cancer, 1st line melanoma, 1st and 2nd line pancreatic cancer, 1st line ovarian cancer, and 1st line gastric.
Posted on November 25, 2008 @ 08:46 am
DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biotechnology company
Crucell N.V., have signed a commercial license agreement with Hungary-based Gedeon Richter Plc. Under the agreement, Gedeon Richter will be allowed to develop and produce certain biopharmaceuticals using the PER.C6 platform.
Crucell's PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. DSM's XD technology has been developed as a system to drive yield improvements in mammalian systems.
Terms of the agreement were not disclosed.
Posted on November 24, 2008 @ 09:15 am
King Pharmaceuticals, Inc. has agreed to acquire
Alpharma, Inc. for approximately $1.6 billion. The agreement, if approved by shareholders, will expand King's pain drug business with Alpharma's drug Kadian and pain patch Flector. Alpharma also has an experimental pain drug Embeda.
An FDA advisory panel recently stated that the morphine-based Embeda is somewhat less attractive to drug abusers, which the agency may require the company to claim on its label. King and partner Pain Therapeutics have a similar drug, Remoxy, pending approval. An advisory panel said Remoxy appeared less susceptible to abuse than other similar drugs such as Purdue Pharma's Oxycontin.
According to a company statement, King expects to achieve cost savings of $50 million to $70 million in the second full year following completion of the transaction, mainly from general and administrative cost cuts and R&D savings, as well as avoiding the expense of new sales representatives for the launch of its new pain drug.
In 2007 King's revenue was $2.7 billion and Alpharma's revenue was $722 million.
Posted on November 24, 2008 @ 09:11 am
Bristol-Myers Squibb has exercised its option to develop and commercialize
Exelixis Inc.'s IND candidate XL413, a selective inhibitor of Cdc7 targeting cancer cells. Under the terms of the collaboration agreement, BMS' selection of XL413 entitles Exelixis to a milestone payment of $20 million. In addition, Exelixis has exercised its option to co-develop and co-commercialize the drug in the U.S. Following the transfer of the development program BMS will lead all global activities. The parties will co-develop and co-commercialize XL413 in the U.S. and share those profits 50/50. Exelixis will be entitled to receive royalties on product sales outside of the U.S.
“To our knowledge, no other selective inhibitors of Cdc7 have advanced to this stage of preclinical development, giving XL413 the potential to become a first-in-class therapy,” said Michael M. Morrissey, Ph.D., president of R&D at Exelixis. “Our colleagues at Bristol-Myers Squibb have substantial expertise in developing and commercializing innovative cancer therapies, and we are excited to have another opportunity to work with them.”
“Providing innovative medicines to patients with cancer is central to our company’s mission,” said Francis Cuss, senior vice president, Discovery and Exploratory Clinical Research, BMS. “Cdc7 inhibition represents a novel approach to cancer treatment and we are pleased to add XL413 to our growing pipeline of cancer compounds, and to further expand our productive collaborations with Exelixis.”
Posted on November 24, 2008 @ 09:08 am
Akorn, Inc. has entered into a five-year contract manufacturing supply agreement with an undisclosed drug company. Akorn will be responsible for the manufacturing and supply of the ophthalmic drug product. Akorn is the ANDA holder and expects to begin supplying the product in the first half of 2009.
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “We are very pleased to have been selected as the contract manufacturer for this ophthalmic product. The completion of this agreement represents the fifth new ophthalmic partnership in 2008 for our contract manufacturing business. We continue to seek opportunities in ophthalmics, liquid and lyophilized injectable products in order to expand our contract pharmaceutical business segment revenues.”
Posted on November 24, 2008 @ 09:05 am
The U.S. District Court for the District of New Jersey has granted
AstraZeneca Pharmaceuticals' motion for a temporary restraining order (TRO) halting sales of Teva's generic Pulmicort Respules (budesonide inhaled solution). In conjunction with the order against Teva, AZ will also stop all sales of its authorized generic budesonide inhalation suspension product and take the necessary steps to comply with the Court's decision. Par Pharmaceutical is the licensed distributor for AZ's generic version of Pulmicort Respules.
The TRO remains in effect until further notice by the Court. This action does not impact sales of branded Pulmicort Respules.
Posted on November 21, 2008 @ 09:04 am
Michael Kamarck, Ph.D., has been promoted to president, Technical Operations & Product Supply (TO&PS),
Wyeth. Dr. Kamarck will be responsible for all aspects of technical operations and product supply for the company, including its Pharmaceutical, BioPharma, Vaccine, Consumer Healthcare and Nutritional units. He succeeds
Charles Portwood, who has been appointed to the new role of executive vice president, TO&PS Operational Excellence. Both positions will report to Joseph Mahady, president, Wyeth Pharmaceuticals.
Dr. Kamarck joined the company in 2001 and successfully led the expansion of Wyeth's global biotechnology manufacturing network. Dr. Kamarck previously served as executive vice president, TO&PS where he was responsible for biotechnology and pharmaceutical operations at 13 international sites and for process development of the late-stage pipeline. Before joining Wyeth, Dr. Kamarck served as senior vice president of operations for the newly formed Bayer Biologicals.
"Dr. Kamarck brings strong leadership as well as superb technical and scientific skills to this critical role. He will continue the transformation of our TO&PS organization as we supply medicines of exceptional quality to our customers and patients," said Mr. Mahady.
Mr. Portwood joined Wyeth in 2001 as president, Global Supply Chain, Wyeth Pharmaceuticals and has guided the transformation of the TO&PS organization.
"Charlie has taken our TO&PS organization to a whole new level of competency and performance," said Mr. Mahady. "He has been instrumental in creating this succession plan and in building a depth of talent in the TO&PS leadership team. We are pleased he will remain an integral part of the Wyeth organization. We are counting on him to support improvement and standardization efforts across the Wyeth manufacturing network."
Posted on November 21, 2008 @ 09:03 am
GlaxoSmithKline received approval from the FDA for Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta is the first oral thrombopoietin (TPO) receptor agonist therapy for the treatment of adult patients with chronic ITP.
Chronic ITP is a bleeding disorder marked by increased platelet destruction and/or inadequate platelet production in the blood. Promacta has been shown to stimulate cells in the bone marrow to produce platelets.
As a result of the approval, Ligand Pharmaceuticals will be entitled to receive a $2 million milestone payment from GSK. Ligand will also earn royalties in the range of 5%-10% on annual sales of the drug.
GSK also reported positive Phase II data in patients with thrombocytopenia associated with hepatitis C and initiated two Phase III trials in patients with hepatitis C in 4Q07. A Phase II study in patients with chemotherapy-induced thrombocytopenia has been completed, a Phase III study is ongoing in chronic liver disease and a Phase I study is ongoing in patients with sarcoma receiving the adriamycin and ifosfamide regimen. GSK expects an MAA submission for the long-term treatment of ITP by the end of the year.
Posted on November 20, 2008 @ 06:41 am
Isogen has made the first phase launch of its contract aseptic manufacturing facility in Delaware. Isogen's Phase I facility will accommodate GMP vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. Isolator-based lyo-capacity is planned for later in 2009.
The company contends that its facility will enable customers to "plan and execute the supply of integrated sterile clinical and small scale commercial launches of single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives."
"Isogen's facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply," said Les Edwards, Isogen's chief executive officer. "Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with cGMP standards. At the same time many new pipeline drugs moving into clinical trials require unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards."
Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting. Isogen's Advanced Sterile Filling offers full product segregation and isolator-based sterile processing. The facility meets global regulatory standards and operates according to cGMP, the company assures.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 20, 2008 @ 06:33 am
Carlos V. Paya, M.D., Ph.D., will be named president,
Elan Corporation, plc on November 25, 2008. Dr. Paya will be based at Elan’s South San Francisco campus, with particular focus on and responsibility for leading the company’s scientific, clinical and medical initiatives and delivering successful results in these areas. He will also bring additional depth and executive management perspective to Elan’s strategic assessments and decisions in all areas of the company.
Kyran McLaughlin, chairman of Elan's board, said, “As an immunologist, a former vice dean of Clinical Investigation at Mayo, and as a successful industry executive, Dr. Paya has a unique set of attributes and experiences that perfectly match the opportunities and challenges facing Elan.”
Dr. Paya will lead the continued integration of Elan’s R&D teams, and all of the company’s medical, scientific and research functions will be accountable to him, including Development, Research, Clinical Relationships and the offices of the chief scientific officer and chief medical officer. The chief medical officer will also retain specific accountabilities to chief executive officer Kelly Martin, as they relate to patient safety.
Dr. Paya will also assume responsibility for Elan’s commercial and marketing functions, with a primary focus on strategic planning, marketing positioning and product life cycle management. The company’s corporate and business development responsibilities will be shared by Dr. Paya and
Shane Cooke, Elan’s executive vice president and chief financial officer.
Dr. Paya joins Elan from Lilly, where he was vice president, Lilly Research Laboratories and Global Leader of the Diabetes and Endocrine Platform, responsible for the company’s insulin franchise.
Prior to Lilly, Dr. Paya had a 16-year relationship with the Mayo Clinic in Rochester, MN, which began with his acceptance into the Mayo Graduate School of Medicine in 1984 and concluded with a six-year tenure as professor of Medicine, Immunology and Pathology and vice dean of the Clinical Investigation program.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 20, 2008 @ 06:28 am
Parexel International has opened an office in Lima, Peru to provide regulatory consulting and clinical research capabilities. With the addition of the Peru office, Parexel now has locations throughout five important biopharmaceutical centers in Latin America, which also include Argentina, Brazil, Chile, and Mexico. This expansion further strengthens the company's position as one of the largest biopharmaceutical services providers in this emerging region for clinical development, according to a company statement.
"Parexel has had a presence in Latin America since 1997, and a long-term commitment to providing clients with high quality services in the region," said Josef H. von Rickenbach, chairman and chief executive officer of Parexel. "Due to the increasing globalization of clinical research, client demand for our capabilities in Latin America has been steadily increasing, and over the last seven years Parexel has experienced double-digit growth in the region. Peru is a key growing market in Latin America, with approximately 28 million people. The opening of our Peru office marks a significant opportunity for clients to further expand their clinical development programs throughout Latin America."
Capabilities provided by Parexel's Latin American locations include regulatory advice for clinical development, as well as a broad range of services including project management, site management, data management, medical affairs, biostatistics, and bioanalysis for the conduct of Phase II-IV studies.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 20, 2008 @ 06:25 am
ImClone Systems has received approval from the FDA to manufacture multiple products at its BB50 manufacturing facility. This approval significantly expands ImClone’s total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.
“This multi-product FDA approval of BB50 significantly enhances ImClone’s operational flexibility as we scale up production of our robust pipeline of proprietary antibodies for the growing number of Phase II and III trials that will be commencing in the next year,” said Richard P. Crowley, senior vice president, Biopharmaceutical Operations of ImClone. “ImClone has one of the largest biologic production capacities in the world and this approval is an important milestone in our efforts to maximize the global potential of both Erbitux and our portfolio of novel fully-human antibodies, which together represents one of the deepest pipelines in oncology today.”
ImClone’s 250,000-sq.-ft. multi-suite BB50 facility received FDA approval to manufacture Erbitux in August 2007. Together with the company’s BB36 manufacturing facility, ImClone has a total production volume capacity of up to 140,000 L at its Branchburg, NJ campus. This is among the largest antibody manufacturing capacities in the biotechnology industry and is a key component of ImClone’s fully integrated operations supporting the development and commercialization of the company’s antibodies, according to an ImClone statement.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 20, 2008 @ 06:20 am
PacificGMP has entered into a cGMP contract manufacturing agreement with
Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer. PacificGMP will manufacture and perform fill/finish of Actinium's HuM195 monoclonal antibody for a Phase I/II clinical trial. A stability study of the final product will also be conducted. HuM195 is a monoclonal antibody that is currently being tested in a Phase I trial to treat acute myeloid leukemia.
"We are delighted to establish a partnership with Actinium Pharmaceuticals and initiate cGMP production for their new Phase I/II clinical trial," said Leigh N. Pierce, president of PacificGMP. "With our strong track record of monoclonal antibody production, this project is a perfect fit for our companies and we look forward to efficiently providing Actinium with a high quality GMP product."
"We are excited to work with PacificGMP, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities and ability to quickly step into this role are precisely what Actinium was looking for in a manufacturing partner," said Howard Wachtler, president and chief executive officer for Actinium.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 18, 2008 @ 09:08 am
Rich Fante has been named president of
AstraZeneca's U.S. business. Mr. Fante takes over from
Tony Zook, whose role was expanded after recently being named president of MedImmune, AZ's wholly-owned biologics business. Mr. Zook is chief executive officer of AstraZeneca North America and head of global marketing.
Said Mr. Zook, "Rich brings strong leadership and a wealth of experience that is invaluable to our business and for improving patient health."
Previously, Mr. Fante served as AZ's vice president, Brand Strategy & Portfolio Operations. He led the development and execution of marketing strategies for all AZ brands in the U.S. He has held a number of leadership roles in his 13 years at AZ, including vice president-Primary Care for the gastrointestinal and respiratory franchises, including Nexium and Pulmicort Respules.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 18, 2008 @ 07:00 am
Nancy Lurker has been named chief executive officer of
PDI, Inc., a provider of contract sales and commercial services to the biopharmaceutical industry. She was also named to the board of directors.
Ms. Lurker previously served as senior vice president and chief marketing officer for Novartis Pharmaceuticals Corp., the U.S. subsidiary of Novartis AG, where she oversaw a product portfolio in multiple therapeutic areas representing multi-billion dollars in annual sales. While at Novartis she launched numerous products including Exforge, Tekturna, Reclast and Exelon Patch, as well as several marketing and productivity initiatives.
Prior to Novartis she was president and chief executive officer of ImpactRx, a privately owned company offering among its services the evaluation of the impact of pharmaceutical promotion on the prescribing behavior of the nation's highest prescribing physicians.
“I am excited to be joining PDI,” said Ms. Lurker. “PDI is a company with a long and proven heritage. I believe in its long-term future. While there are industry and company challenges, my goal will be to focus on strategies for growth and to return the company to profitability. Customer focus, sales excellence and superior service delivery will be at the top of our agenda. I look forward to working with the people of PDI and its customers as we solidify a long-term growth track.”
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 17, 2008 @ 08:47 am
The FDA plans an Accelerated Approval for
Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval verification study and the FDA must complete its review of the Risk Evaluation and Mitigation Strategy (REMS) for the product. Genzyme submitted the REMS earlier this month. The FDA has classified this submission as a major amendment to the BLA for Myozyme produced at the 2000 L scale, and has extended the PDUFA date by 90 days to February 28, 2009. Genzyme will be required to submit the final protocol for the verification study after approval.
Genzyme currently has U.S. approval to sell Myozyme produced at the 160 L bioreactor scale, and the company has been seeking clearance from the FDA for 2000 L-scale production. Genzyme submitted a separate BLA for the product using the 2000 L manufacturing process on May 30, following a determination by the FDA that Myozyme produced at the 160 L and 2000 L scales should be considered as two separate products because of comparability differences.
“We’re very pleased to have additional clarity from the FDA on what it will take for 2000 L-scale product approval,” said Genzyme’s senior vice president of Global Market Access, Alison Lawton. “The ongoing communication with the FDA has been positive, and the agency has done a substantial amount of work in a short time to facilitate approval of this product for patients.”
Myozyme is a treatment for Pompe disease, a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the U.S. As part of the accelerated approval procedure, a verification study is required to demonstrate clinical benefit of the 2000 L-scale product during the post-marketing period.
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 17, 2008 @ 07:01 am
Lilly and
United Therapeutics Corp. have entered into a license and a supply agreement related to the U.S. commercialization rights for the pulmonary arterial hypertension (PAH) indication of Lilly's molecule, tadalafil. The PAH indication is currently under regulatory review in the U.S, Canada, Mexico, Japan and the EU.
United Therapeutics will make an upfront payment of $150 million to Lilly for the exclusive rights to commercialize tadalafil for PAH in the U.S., as well as for a product manufacturing and supply arrangement. Lilly will manufacture and supply tadalafil to United Therapeutics and will retain authority globally for all regulatory, development, intellectual property and manufacturing aspects of the tadalafil molecule for all potential indications. Lilly will also retain commercialization rights to tadalafil for PAH outside of the U.S. In addition, Lilly will purchase $150 million of common stock from United Therapeutics.
"United Therapeutics brings substantial expertise and passion to the treatment of patients with PAH and will be an excellent partner for this product," commented Dr. Gwen G. Krivi, Ph.D., vice president of Lilly Research Labs and global brand development platform leader for Lilly. "Their experience in this field will greatly enhance the ability to provide tadalafil for PAH, if approved, as a new therapeutic option for this very serious disease. We are also pleased to make a financial investment in a promising and profitable biotechnology company. The collaboration with United Therapeutics adds to the success of Lilly's networking strategy."
"The addition of tadalafil for PAH expands our portfolio and strengthens United Therapeutics' position in the area of cardiovascular disease," said Martine Rothblatt, Ph.D, chairman and chief executive officer of United Therapeutics. "Building upon the success of Remodulin, we are committed to addressing the unmet medical needs of patients. We also welcome the support and confidence expressed by Lilly through their financial investment in our company."
For breaking news from this year's AAPS conference, visit our Live from AAPS site!
Posted on November 14, 2008 @ 09:55 am
Pfizer has launched the Regenerative Medicine research unit. According to the company, this independent unit will research the biology of stem cells and the opportunity they provide to discover and develop a new generation of regenerative medicines for major medical needs. The unit will explore the use of stem cells to develop treatments that may prevent disability, repair failing organs and treat degenerative diseases with the goal of delivering new medicinal products using cells as therapeutics.
Corey Goodman, Ph.D., president of Pfizer’s Biotherapeutics and Bioinnovation Center, said, “The formation of this new unit represents another key step forward in Pfizer’s commitment to be at the forefront of new approaches in biotherapeutics and bioinnovation and to expand our research efforts and expertise into emerging areas of biomedical science, like regenerative medicine, that have great potential for human health.”
The unit will be led by chief scientific officer Ruth McKernan, Ph.D. Dr. McKernan said, “I’m very excited to lead this new research unit. While there is still a lot to understand about how stem cells can be used therapeutically, we believe it is one of the most promising areas of scientific research.”
Pfizer Regenerative Medicine will operate as one of the company’s new small, independent research units aimed at bolstering the biotechnology culture and environment. The unit will be co-located in the biotech hubs of Cambridge, UK and Cambridge, MA. It is expected to expand to employ 70 researchers. According to the company, these scientists will operate in small, flexible teams, with the capability to make decisions quickly and effectively. The Cambridge UK site will focus on neural and sensory disorders. The Cambridge, MA site will focus on endocrine and cardiac research.
Posted on November 14, 2008 @ 09:53 am
ADMETRx, a contract research group that provides in vitro ADME discovery support, will collaborate with
Roche to advance the development of its multicriteria decision-making models applied to drug discovery.
ADMETRx chief executive officer and chief scientific officer Phil Burton, Ph.D., said, “Effectively using all the data available in a discovery program to prioritize or advance candidates with the best development potential is a significant challenge in the pharmaceutical industry. The multi-criteria decision-making methods developed by ADMETRx are intended to help Roche scientists to make these critical decisions, ultimately improving the success of candidates at each step in the development process.”
Posted on November 14, 2008 @ 09:50 am
Sigma-Aldrich has entered a distribution agreement with
AlphaGenix, Inc., a developer and manufacturer of products for basic and clinical life science research. Sigma-Aldrich will now be the exclusive supplier of AlphaGenix-developed antibodies and research tools for the fields of regenerative medicine and stem cell biology.
The new product offerings include antibodies to stem cell markers and the tools for 3-D stem cell culture systems, such as MaxGel, a human derived extracellular Matrix (ECM) and HydroMatrix, a synthetic peptide that offers the precision and control of a synthesized matrix of a highly crosslinked peptide hydrogel. Both MaxGel and HydroMatrix promote cell growth and migration and have been shown to support the proliferation and enhance function of many cell types, including neural stem cells, neurons, glia, astrocytes, fibroblasts, and keratinocytes.
"It is increasingly important to design cell culture assays that closely mimic the behavior of cells in living tissues," said Carl Schrott, director of marketing for regenerative medicine and research cell culture at Sigma-Aldrich. "Through this partnership, we will offer our customers new tools to grow stem cells that resemble their in vivo counterparts, and the high-quality antibodies needed to study them."
Posted on November 13, 2008 @ 09:40 am
Curis, Inc. and its collaborator
Genentech granted a license to Roche for rights (outside the U.S.) to GDC-0449, an oral small molecule Hedgehog pathway inhibitor. Roche, through a previous agreement with Genentech, had an option to obtain a license to commercialize certain Genentech products in non-U.S. markets.
“We are pleased with Roche’s exercise of its option to license ex-U.S. rights to GDC-0449 from Genentech. We believe the collaborative worldwide development activities of Genentech and Roche could greatly expand the potential value of this compound,” said Curis president and chief executive officer, Dan Passeri. “Roche brings its significant clinical development and commercialization experience to advance and market GDC-0449 outside of the U.S. We are extremely pleased with our collaborator Genentech’s progress in advancing GDC-0449 and we believe that Roche’s experience will complement Genentech’s ongoing development efforts.”
Genentech discovered GDC-0449 and under the collaboration agreement with Curis, was jointly validated through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of the drug. Under the terms of Curis’ collaboration agreement with Genentech, Curis is eligible to receive cash payments upon the successful achievement of certain clinical development and regulatory milestones, as well as royalties on potential sales.
GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech expects to initiate additional Phase II trials in advanced ovarian cancer and advanced basal cell carcinoma in the coming months.
Posted on November 13, 2008 @ 09:39 am
Tony Zook has been appointed president of
MedImmune. Mr. Zook was previously responsible for heading the company on an interim basis. MedImmune is the wholly owned biologics business for AstraZeneca and in addition to MedImmune, Mr. Zook is responsible for AstraZeneca's U.S. and Canadian businesses, as well as its global marketing organization.
"I am pleased to continue working with the leadership team here at MedImmune to advance our strategic plan to discover, develop and deliver innovative biologic treatments that can positively impact patient health," said Mr. Zook.
Posted on November 13, 2008 @ 09:37 am
UPS is expanding its options for healthcare customers with the addition of a new facility in Puerto Rico. The 150,000-sq.-ft. facility, expected to open in 1Q09, will be capable of storing medical devices and sensitive and perishable pharmaceutical and biotech products, as well as expand a supply chain network for delivery throughout the world. The facility will be located in San Juan and will use the same validated technology platform employed in its U.S. and Canadian healthcare distribution centers.
UPS provides its Proactive Response, a 24-hour proactive monitoring service for healthcare products that notifies customers of potential delays in the supply chain, and for air freight shipments, its Temperature True, a 24-hour monitoring service that tracks as many as 21 shipment milestones to help ensure product integrity.
“Puerto Rico is among the leading markets for pharmaceutical and biotech product research and production worldwide,” said Jorge Castillo, UPS Puerto Rico country manager. “Our new facility will strengthen our distribution network and enrich customers’ opportunities for growth by providing greater global market access and lower cost-sourcing through the UPS network.”
“Our healthcare services are among the most advanced systems in the industry and as a result, UPS provides peace of mind by effectively managing customer supply chains,” said Bill Hook, vice president, global strategy, UPS Healthcare. “Our investments allow us to provide first-class service to the global pharmaceutical industry.”
Posted on November 12, 2008 @ 08:57 am
Biovitrum AB and
Wyeth have extended their ReFacto supply agreement through December 31, 2015. Biovitrum will continue to be the sole producer of drug substance for Wyeth for ReFacto, as well as Xyntha/ReFacto AF, the successor products, and will continue to receive royalties from Wyeth's global sales. Biovitrum's co-promotion rights in the Nordic region remain unchanged. Biovitrum's total revenues from the ReFacto business amounted to $143 million in 2007. ReFacto, Xyntha and ReFacto AF are recombinant protein drugs for hemophilia A.
"We are very pleased to be able to announce the prolongation of our long and successful collaboration with Wyeth. The agreement enables us to together provide the new improved Xyntha and ReFacto AF internationally, and to improve the lives of hemophilia patients." commented Martin Nicklasson, chief executive officer of Biovitrum. "The agreement validates our biotechnology therapeutic production capabilities and expertise."
Posted on November 12, 2008 @ 08:47 am
Compass Pharma Services, though its partnership with Mactec Packaging Technologies, is offering customers Mactec's packaging machines for short-run blister packaging applications as well as its custom tooling and package design services. Mactec manufactures small-footprint blister packaging machinery for hospital unit dose and other short-run packaging applications. The two companies formed a strategic alliance in August 2007. Compass Pharma has also restructured its customer service organization and processes in an effort to provide contract pharmaceutical packaging customers with faster and more personal service for packaging projects.
"For project clarity and efficiency, our new organization means customers have a single point of contact and communication for all contract packaging jobs," said Kevin Flanagan, chief executive officer, Compass Pharma Services. "Because of this new organization, we are more responsive and agile when responding to complex or deadline-intensive tasks such as pharmaceutical blister packaging for new drug launches, stability testing or seasonal spikes in demand.
Don Wrocklage will continue to lead Compass Pharma's customer service and sales administration department. He has worked for the company and its predecessor organizations for 30 years and has expertise in contract pharmaceutical packaging engineering and has contract pharmaceutical manufacturing knowledge.
The company has appointed two new sales administrators, Joanne Sountis and John Perla. Prior to joining the company, Ms. Sountis worked as a medical assistant in an orthopedics medical practice. She is a member of the American Managed Care Pharmacy Association, American Pharmacists Association and the New Jersey Society of Health Systems Pharmacists. Mr. Perla previously worked as head of administration for a division of Ferguson Enterprises, a national distribution company.
Posted on November 12, 2008 @ 08:46 am
Merck Serono recently held a cornerstone ceremony at the Merck Serono Biotech Center (MSBC), its production site in Corsiersur-Vevey, Switzerland, to mark the expansion of the site. The expansion will enable the production of greater quantities of Erbitux, in order to meet growing patient needs, as well as the production of potential future treatments in autoimmune and inflammatory diseases currently under clinical development. Erbitux, Merck Serono’s monoclonal antibody for the targeted treatment of colorectal and head and neck cancers, is currently available in around 70 countries.
“The expansion of the Merck Serono Biotech Center embodies our company’s primary commitment to bringing therapeutic innovations to patients with serious unmet medical needs,” said Elmar Schnee, general partner and board member of Merck KGaA and president of Merck Serono. “This investment will cement our company’s position as a leader in biotechnology, while contributing to the local economy with the creation of more than 200 new jobs, and its construction will create business opportunities for local companies.”
Hanns-Eberhard Erle, executive vice president Technical Operations of Merck Serono, added, “This expansion underscores our commitment to excellence at all levels and will serve as a catalyst towards our goal of becoming a responsible world leader in providing specialist therapies. Through efficient manufacturing processes to scale up the production and the use of state-of-the-art technologies, the Merck Serono Biotech Center will continue to be one of the top centers of excellence for biotechnology in the world.”
Two new dedicated production suites with 120,000 liters of bioreactor capacity, plus a state-of-the-art wastewater treatment station and a logistic center, will be added to the existing facilities by the end of 2010. After inspection by worldwide health authorities, including the EMEA and Swissmedic, the production of Erbitux is expected to start at the MSBC in 2012.
Posted on November 11, 2008 @ 09:26 am
Avid Bioservices, Inc. is expanding its biomanufacturing capabilities with the installation of two Thermo Scientific HyClone Single-Use Bioreactors (SUB) at its facility in Tustin, CA. These systems enhance the company's cell culture production services. The purchase of the 1000 L SUB follows the successful evaluation of a 100 L SUB in the company’s process development labs.
The HyClone bioreactors consist of a reusable stainless steel outer support container and SUB BioProcess Container (BPC) that integrates with existing bioreactor control systems, providing the advantages of single-use bioprocessing without having to install a new bioreactor system. The retrofit product replaces the stainless steel bioreactor vessel in existing bioreactor systems, making it a flexible and economic option to increase bioreactor capacity, according to the company.
The company plans to use the 100 L SUB to produce antibodies and recombinant proteins in multi-gram quantities for clients and will also support the scale-up work for the 1000 L S.U.B, which will be used to produce clinical material under cGMP conditions.
“The growing demand for our biomanufacturing services led us to assess a number of options for increasing our capacity while maintaining our high quality,” said Richard Richieri, senior vice president of bioprocess development and manufacturing at Avid Bioservices. “The Thermo Scientific HyClone SUB disposable system provides a state-of-the-art cell culture production solution that is cost-effective and complements our existing bioreactor production suite. Based on our positive evaluation of the 100 L system, we are pleased to proceed with the larger unit, making Avid the first company in southern California to install the 1000 L SUB system.”
Posted on November 11, 2008 @ 09:22 am
David W. Keiser, will retire from his position as president of
Alexion Pharmaceuticals by the end of this year. Mr. Keiser, a co-founder of Alexion, played a central role in the commercial launch of Soliris in the U.S. and Europe, and helped to build a broad platform for continued growth in those and other territories. He was appointed chief operating officer since 1992 and president in 2002. Mr. Keiser will remain on the board of directors through the expiration of his current term in 2009 and will be available for consultation in the future. His responsibilities will be distributed among current members of the senior management team, reporting to Leonard Bell, M.D., the company's chief executive officer.
Mr. Keiser joined the company shortly after it was established in 1992, as executive vice president and chief operating officer. He played a central role in managing the company's manufacturing and regulatory efforts and established commercial teams in the U.S. and Europe to support the 2007 launch of Soliris.
"David is a unique individual and executive and I have enjoyed working with him as Alexion built its global organization. His top-level expertise and broad experience were instrumental in our evolution from the early group of scientists into an international organization that is now able to deliver Soliris to a growing number of patients in a growing number of countries," said Dr. Bell. "Under David's leadership, we initiated the development of our world-class teams in the U.S. and Europe, and laid a strong foundation for market entry in Asia and the Pacific, the Middle East and Latin America. We are deeply grateful to his numerous, durable contributions to Alexion, and to the people and processes he has put in place to ensure our ongoing success in coming years."
Posted on November 11, 2008 @ 09:19 am
BioBlocks, Inc. and outsourcing partner,
MannKind Corp., will continue their lead optimization collaboration. The two companies have worked together since January 2007, and have met milestones utilizing BioBlocks' expertise in medicinal chemistry and lead optimization and Mannkind's experience with novel therapeutic modalities. According to the companies, the success of the partnership is attributed to the focus on integrating project management towards a results-based collaboration, as opposed to fee-for-service outsourcing. Financial terms were not disclosed.
Based on its progress with certain drug targets, MannKind was able to explore new mechanisms of action for a first-in-class therapeutic for an important disease indication. BioBlocks led the group to a series of potent, selective, and efficacious lead compounds over a period of 18 months. The project utilized BioBlocks' facility in Budapest, Hungary to maximize medicinal chemistry FTE resources, including sophisticated chemistries, chemical series development, and cheminformatics.
Qingping Zeng, associate director, medicinal chemistry and lead discovery of MannKind, said, "Our lead discovery and optimization collaboration with BioBlocks has helped us reach important milestones in our first project with them, leading to increased momentum and visibility for the initiative. We have found BioBlocks' results-oriented medicinal chemistry approach to be a very valuable asset to our drug discovery programs, and we are pleased to continue our collaboration with them."
Posted on November 10, 2008 @ 09:00 am
WuXi PharmaTech has signed a new three-year, in vitro ADME collaboration agreement with
Pfizer. The companies will establish ADME assays to provide in vitro screening services on compounds WuXi PharmaTech synthesizes for Pfizer. The evaluation of ADME properties is a key step in the drug discovery and development process. WuXi's goal is to provide key information for the improvement of pharmacokinetic properties of Pfizer's compounds.
The two companies have been involved in various collaborations, including synthetic chemistry, parallel medicinal chemistry (PMC), and ADME and bioanalytical services.
"This new agreement further strengthens our already productive relationship with Pfizer, one of our largest customers for many years, and it is the direct result of our research capability and firm commitment to quality and customer satisfaction," said Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech.
"A high quality and flexible Asia R&D partnership network is critical to Pfizer's emerging market and Asia strategy. We want to build a strong relationship with leading CROs such as WuXi PharmaTech to tap into the scientific talents and R&D capabilities in Asia," commented Dr. Steve Yang, vice president and head of Asia R&D at Pfizer.
Posted on November 10, 2008 @ 08:56 am
GlaxoSmithKline and
XenoPort, Inc. withdrew the NDA for Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has requested that the data in a single study be reformatted. GSK will conduct a review of other trial data sets as well. The withdrawal does not relate to the content of the filing. GSK plans to resubmit the NDA as soon as the revisions are made.
The resubmission delays a $23 million milestone payment to XenoPort from GSK and Astellas Pharma, associated with the acceptance of the NDA for Solzira. Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by using high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.
Posted on November 10, 2008 @ 08:52 am
ArQule, Inc. and
Daiichi Sankyo Co., Ltd. have entered into two agreements forming a strategic relationship for the development and discovery of new oncology therapeutics.
The two companies will co-develop ARQ 197, an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase, to treat cancer. They will also advance the application of ArQule’s kinase inhibitor discovery platform (AKIP) to develop a new generation of highly selective anti-cancer kinase inhibitors. Daiichi Sankyo will pay a $75 million upfront payment to ArQule for the two agreements.
“We are delighted to welcome Daiichi Sankyo as a partner in our shared quest to bring innovative cancer therapeutics to patients and their physicians,” said Paolo Pucci, chief executive officer of ArQule. “With this announcement, we complete the ARQ 197 partnership process and set the stage to bring the ARQ 197 development program to the next level. We are also very pleased to broaden this relationship by welcoming Daiichi Sankyo as our first partner for ArQule’s AKIP platform.
“Daiichi Sankyo looks forward to being able to collaborate with ArQule to realize differentiated and innovative approaches in the treatment of these devastating diseases,” said Takashi Shoda, president and chief executive officer of Daiichi Sankyo. “This strategic partnership is the next important milestone for Daiichi Sankyo to solidify a strong and viable pipeline in oncology.”
Posted on November 7, 2008 @ 08:47 am
Bilcare Global Clinical Supplies has enhanced its ability to develop formulation dosage forms for preclinical and early-phase drugs with the addition of fluid bed granulation technology and the In-Cap capsule system.
The fluid bed granulation technology extends Bilcare's solid-dosage formulation capabilities. The system is equipped with Wurster coating inserts, enabling the delivery of specialized, high-precision coating processes for granules and non-pareils for the creation of sustained- and controlled-release tablet and capsule formulations.
The In-Cap capsule system for preclinical and early-stage development is capable of filling several thousand capsules per hour in multiple permutations. This equipment adds development and clinical manufacturing capabilities for various formulation types, including powders, pellets, tablets and liquids.
According to Vincent Santa Maria, president of Bilcare GCS, Americas, the addition of new technology is part of the company's capital investment program in its U.S. facilities. "With these upgrades, Bilcare GCS can now quickly produce a wider variety of drug dosage forms with high product quality at or above industry standards," he said. "These investments in R&D services further prove our commitment to being a full-service partner to our global customers."
Posted on November 7, 2008 @ 08:45 am
InNexus Biotechnology has developed a new antibody product from its DXL platform technology, DXL1218 (EGFR), for the potential treatment of colorectal cancer.
"Recent experimental data suggests that DXL1218 (EGFR) is superior to competing commercialized products on the market, such as Erbitux, in terms of potency and efficacy," said Jeff Morhet, chief executive officer and chairman of InNexus. "I am very excited, as this latest development lends further support to the robustness and predictability of the DXL platform and the superiority of products from the platform over presently commercialized offerings."
Research partner, Pablo Legorreta, chief executive officer of Royalty Pharma, said, "We are quite pleased with the rapid progress of InNexus. Jeff has had a vision for rapid product development based on DXL technology coupled with advanced in vivo studies and a significant regulatory strategy. We look forward to their continued rollout of products and performance."
Posted on November 7, 2008 @ 08:43 am
AMRI
3Q Revenues: $61.4 million (+29%)
3Q Earnings: $7.0 million (+250%)
YTD Revenues: $172.9 million (+19%)
YTD Earnings: $17.4 million (+78%)
Comments: Total contract revenue for the quarter was $54.1 million (+30%). Discovery Services revenue was $16.4 million (+57%). Development/Small Scale Manufacturing revenue was $14.5 million (+11%). Large Scale Manufacturing revenue was $23.2 million (+29%). Allegra royalties dropped 5% to $5.7 million. Milestone revenue from the company's licensing agreement with BMS was $1.5 million in the quarter. Earnings also include a $1.2 million adjustment to record income tax benefits from certain R&D activities.
Posted on November 6, 2008 @ 09:38 am
Pfizer is discontinuing the Phase III development program for its investigational compound (CP-945,598) for weight management. CP-945,598 is a selective antagonist of the cannabinoid type 1 (CB1) receptor. The company has decided to discontinue the development program based on changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval.
“While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” said Martin Mackay, president, Pfizer Global R&D. “As part of our ongoing portfolio prioritization, we will refocus research and development resources on high priority therapeutic areas that address an unmet medical need and have a high probability for success.”
Sanofi-Aventis is also discontinuing all trials of its obesity drug, Acomplia. According to a Sanofi-Aventis statement, the decision was made "in light of recent demands by certain national health authorities."
The company recently suspended sales of Acomplia in Europe following the recommendation from the EMEA to temporarily suspend sales because of risks that include depression, anxiety and stress disorders. The drug had been marketed in 18 EU countries since 2006.
The FDA rejected the drug last year after a panel of advisers recommended doing so, citing Acomplia's increased risk of suicidal thoughts.
More than 700,000 overweight and obese people around the world have been treated with Acomplia, gaining significant health benefits, according to Sanofi-Aventis. The company had been testing it for use in various types of patients including a possible treatment for cigarette smoking cessation. The drug is believed to work by blocking the same pleasure centers in the body that are stimulated when marijuana smokers get very hungry.
Posted on November 6, 2008 @ 09:27 am
GlaxoSmithKline plans a 12% (or 1,800) reduction in its U.S. sales force as part of a restructuring effort. The company plans to shift some sales representatives from its pharmaceutical unit to its vaccine unit, which will result in a reduction of about 1,000 employees. That will leave it with a U.S. sales force of about 7,500 by the end of the year.
As part of the restructuring, the company plans to group its sales staff around specific treatment areas such as respiratory, for the asthma drug Advair and allergy medicine Veramyst, rather than geographically, as it had been organized in the past. According to GSK spokeswoman Mary Anne Rhyne, health professionals have told the company that "they want to see fewer reps but want to see people with specialized training and information."
According to the company, Research Triangle Park, NC will be designated as its sole U.S. headquarters. Previously, the company's site in Philadelphia shared this status. Ms. Rhyne said no significant work-force cuts would take place immediately in Philadelphia.
Posted on November 6, 2008 @ 09:24 am
Patheon has opened its new headquarters for its European operations in Zug, Switzerland. The new headquarters will manage the company's commercial and pharmaceutical development services sales, marketing and customer support activities in Europe. Certain support functions — such as procurement and supply chain — will also be managed in Zug, which is near Zurich.
"Patheon has grown rapidly in Europe through acquisition and organic growth with sites located in France, Italy, and the UK. Thus far the sites have operated more independently, which is less than ideal for effective and harmonized communications to our clients. By moving key European managers to a regional headquarters and centralizing the key business functions for our operations across all European sites in one distinct location, Patheon will be more nimble to accelerate growth in the region, enhance profitability and ultimately better serve our clients," said Wes Wheeler, Patheon's chief executive officer and president.
"We are relocating key European decision-makers from our existing sites in Europe to our new European headquarters and intend to recruit positions locally. We expect to employ approximately 25 people in Zug," said Aldo Braca, president of Europe. "The quality, education-level, and accessibility of a multilingual local labor force are very high in Zug. This coupled with its efficient and business friendly administration makes it an ideal location for our European headquarters."
Posted on November 5, 2008 @ 09:48 am
Kendle
3Q Revenues: $181.1 million (+27%)
3Q Earnings: $11.0 million (+189%)
YTD Revenues: $517.3 million (+25%)
YTD Earnings: $24.4 million (+98%)
Comments: Early stage revenues were $11.2 million (+138%). Late stage revenues were $110.9 million (+19%). The acquisition of DecisionLine Clinical Research Corp. accounted for 6% of growth in the quarter. New business awards totaled a record $212 million in the quarter, (+21%). Contract cancellations totaled $38 million or 18% of sales for the quarter. Net income for 3Q07 included a charge for the write-off of deferred financing costs related to the company's term debt. Services revenues in the quarter by geographic region were as follows: North America (+50%); Europe (+37%); Latin America (+9%); Asia-Pacific (+4%).
Posted on November 5, 2008 @ 09:47 am
Hospira
3Q Revenues: $925.5 million (+10%)
3Q Earnings: $81.8 million (+38%)
YTD Revenues: $2.7 billion (+9%)
YTD Earnings: $216.3 million (earnings were $60.7 million YTD07)
Comments: Revenue growth in the quarter was driven by strong sales in Specialty Injectable Pharmaceuticals as well as increased demand in Medication Management Systems product lines. Sales increased in all segments: the Americas (+10%); Europe (+10%), Middle East and Africa (EMEA) (+23%). YTD07 earnings reflect Mayne Pharma integration and other acquisition-related charges.
Posted on November 5, 2008 @ 09:29 am
Enzon
3Q Revenues: $49 million (+4%)
3Q Loss: $2.0 million (earnings were $87.5 million in 3Q07)
Comments: Total product sales were $28.9 million in the quarter (+16%) driven by Oncaspar sales, up 19% to $12.5 million. Contract manufacturing revenues were $5.3 million (+40%) due to growth from additional business and timing of shipments to customers. Royalty revenues were $14.6 million (-20%) as a result of the sold portion of Peg-Intron royalties. R&D expenses increased to $15.7 million (+49%) primarily due to $1.0 million in milestones related to the LNA platform program and the increase in costs associated with manufacturing process improvements and pharmaceutical properties of Oncaspar and Adagen.
Posted on November 4, 2008 @ 09:13 am
Metrics, Inc. has opened a new larger scale manufacturing facility. As part of its expansion, the company has brought online two packaging lines, two granulating rooms and three compressing rooms, including a double-sided, 45-station tablet press. This allows the company to handle batch sizes as large as 500 kilograms with a blending capacity of 46 cubic feet and a total capacity of 1 billion tablets per year.
The new manufacturing space is a result of the company’s recently completed $18-million, 47,000-sq.-ft. expansion that doubled the size of its facility. With the expansion, the company can now accommodate topical powders and oral liquids. Specific services include: high shear wet granulation; fluid bed drying; top spray fluid bed granulation; direct compression; direct powder fill encapsulation; Wurster coating; 48-inch pancoating; and bottle packaging. The company can also provide development-, clinical- and commercial-scale controlled substances Schedule II through V. The expansion for these services includes: four new analytical labs; stability storage; a dedicated cytotoxic and potent lab; and a new microbiology lab. The company has also brought antibiotic assay and sterility testing online to offer full microbiological support of sterile products. As part of this growth, the company is adding 50 pharmaceutical scientists and technicians.
“For those of us who have worked with Metrics since its beginning, it has been a long-time dream to offer a full array of services that allow clients to keep development and commercial manufacturing projects under our roof,” said Phil Hodges, president. “It’s exciting to see the dream come to life, and we hope the additional capacity makes Metrics an even more attractive partner to clients and potential clients.”
Posted on November 4, 2008 @ 09:10 am
West Pharmaceutical Services
3Q Revenues: $256.2 million (+6%)
3Q Earnings: $13.3 million (+9%)
YTD Revenues: $806.3 million (+6%)
YTD Earnings: $68.3 million (+5%)
Comments: Pharmaceutical systems segment sales were $190.5 million (+10%). Favorable currency translation contributed 4.7% points of that growth. Sales of traditional vial components, metal Flip-off seals, and safety and reconstitution products grew while prefillable syringe component sales declined due to a lower demand for ESA product packaging. Tech Group segment sales were $68.3 million in the quarter (-4%). Sales in 3Q07 included $7.3 million of sales of the discontinued Exubera device and $3.7 million of packaging for an OTC product.
Posted on November 4, 2008 @ 09:08 am
Stora Enso and
Medixine, a health care software provider, have signed an agreement under which the two companies will partner in marketing a new electronic compliance monitoring service. This service is based on Medixine's mobile and server software and Stora Enso's Pharma DDSi intelligent packaging solution.
Stora Enso's packaging solution reminds patients to take their medications and records when each tablet is taken from the package. This compliance data is stored in the microchip embedded in the package and can be read with a mobile phone and transmitted automatically to a server where it is available to those responsible for the patient's care. Data collection and management are based on Medixine's software.
"Anti-migraine medication is one example of the future applications of this new system. Keeping a migraine diary is easy with the help of the package by simply answering questions about the symptoms. The package automatically records the amounts of drugs taken and the hours at which they were taken. All this information can easily be made available to a doctor in the form of a clear report; all the patient needs to do is touch the pharmaceutical package with his or her mobile phone," said Medixine's managing director, Dr. Tapio Jokinen.
"Lapses of memory and other medication errors are regrettably common when a patient is cared for in his or her own home. This puts the patient's health in jeopardy and causes unnecessary medical costs. Compliance monitoring is also needed by pharmaceutical companies to demonstrate the efficacy of their drugs. Stora Enso's Pharma DDSi package was developed to meet this demand," said Ismo Saarinen, director, Stora Enso Pharmaceutical Solutions. "The services provided by Medixine are based on state-of-the-art technology and the company's software solutions are already used in 16 countries."
Posted on November 3, 2008 @ 09:08 am
Pfizer received approval from the FDA for Toviaz extended release tablets for the treatment of overactive bladder (OAB) symptoms. The once-daily drug can help regulate the involuntary contractions of the bladder associated with OAB over a period of 24 hours. These contractions cause frequent, sudden urges to urinate. Overactive bladder affects an estimated one in six Americans but remains highly undertreated, according to the company. The two doses of Toviaz, 4 mg and 8 mg, allow dosing flexibility to optimize treatment based on the individual patient response and tolerability.
The approval is based on two Phase III studies of 1,964 OAB patients. Patients showed an 88% median reduction in urge urinary incontinence with Toviaz 8 mg versus 50% with placebo. Treatment with 8 mg reduced the number of urinations per day by as much as 19% compared to an 11% reduction with placebo. Reductions in wetting accidents were seen as early as week two of treatment and maintained over 12 weeks.
Posted on November 3, 2008 @ 09:00 am
Halozyme Therapeutics started a Phase II study of recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin R (regular insulin human injection) and with Humalog (insulin lispro) in Type 1 diabetic patients. This study is designed to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics (PK) after administration of each of four study drugs: Humulin R with and without rHuPH20 and Humalog with and without rHuPH20.
This crossover design, single blind, open label study is designed to collect data on at least 20 patients who complete the study. The study allows for insulin dose titration and each patient will receive a minimum of four and as many as three additional study drug injections that include Humalog and Humulin R with and without rHuPH20. Study drug will be injected subcutaneously into the abdomen immediately prior to ingestion of a standardized liquid meal.
The primary endpoint will be a PK measure of the plasma insulin concentration from zero to 60 minutes after injection. Secondary endpoints will include additional PK data, as well as blood glucose concentration at various time points. Safety data such as adverse reactions, hypoglycemia, blood chemistry, and injection site tolerability will be collected, measured and evaluated. Patients may be on study for as long as 14 weeks from screening to completion. Results from the study are expected in mid-2009.
A Phase I euglycemic clamp study in 26 volunteer subjects who received an injection of Humulin R or Humalog with and without rHuPH20, showed that the co-injections were well tolerated and demonstrated faster insulin absorption and shorter time to peak concentration for the insulin plus enzyme combination compared to insulin alone. Metabolic effects such as glucose lowering activity for the combination of insulin plus rHuPH20 were also greater and occurred earlier than for insulin administered alone. Also, the combination of Humulin plus rHuPH20 demonstrated faster insulin absorption and a shorter time to peak concentration when compared to Humalog alone.
Posted on November 3, 2008 @ 08:55 am
Cephalon, Inc., received approval from the FDA for Treanda for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. In March, Treanda received approval for the treatment of patients with chronic lymphocytic leukemia, the most common form of leukemia in the U.S.
Indolent NHL, a subset of non-Hodgkin's lymphoma, is a slow-growing but serious cancer of the lymphatic system that is not curable with currently available treatments. Patients with indolent NHL are prone to multiple relapses after initial therapy. According to the National Cancer Institute, an estimated 30,000 people in the will be diagnosed this year with indolent NHL.
The FDA approval is supported by a trial of 100 patients with indolent B-cell NHL who had progressed during or within six months of treatment with a regimen that included rituximab. The study demonstrated that patients had a high response rate to treatment with Treanda, and these responses to the treatment were durable. The results showed that treatment with Treanda as a single agent resulted in an overall response rate of 74%, which means that after treatment, the cancer diminished or disappeared in approximately three out of four patients. Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months and patients remained alive and their disease did not progress for a median of 9.3 months.
October 2008
Posted on October 31, 2008 @ 10:40 am
Sanofi-Aventis
3Q Revenues: $9.9 billion (-2%)
3Q Earnings: $1.9 billion (-27%)
YTD Revenues: $29.6 billion (-3%)
YTD Earnings: $5.3 billion (-18%)
Comments: Pharmaceutical sales in the quarter were up 5% to $8.5 billion, driven by the company's top 15 products. Lovenox sales were $917.5 million (+9%). Plavix sales were $910.3 million (+6%). Lantus sales were $884.3 million (+29%). Taxotere sales were up 17% to $261.5 million. Aprovel sales were up 15% to $430.6 million. Copaxone sales were $144.5 million (+19%). In the U.S., sales of Ambien CR and Ambien IR totaled $177 million and $28 million respectively. Vaccines revenue was $1.4 billion in the quarter (+9%). Flu vaccines were up 10% at $540.4 million. Polio/Pertussis/Hib Vaccines were up 43% to $280.3 million. R&D expenses were flat at $1.6 billion in the quarter (or +4.5% after excluding the effect of exchange rates). In the quarter, the company completed the acquisitions of Acambis (vaccines) and Symbion (nutraceuticals/OTC, Australia). 3Q and YTD results include the unfavorable effect of exchange rates.
Posted on October 31, 2008 @ 10:38 am
Sartorius Stedim Biotech GmbH (SSB) signed an agreement to acquire the Swiss-based technology company
Wave Biotech AG. The two companies have been working together since 2006 on joint research projects. SSB has been exclusively marketing Wave's product range that covers various types of single-use bioreactors and other equipment for biopharmaceutical research and manufacture.
Wave Biotech AG provides disposable bioreactors, which are an alternative to traditional reusable stainless steel systems used by the biopharmaceutical industry to produce products such as vaccines and monoclonal antibodies. According to the company, Wave bioreactors offer biopharmaceutical manufacturers more flexible process designing and lower costs for cleaning and validation.
“We are acquiring a company with a very strong track record in innovation and with competencies in fermentation that are outstandingly complementary with our own breadth of expertise in this area. In making this move, we are reinforcing our position in the fast-growing segment of single-use systems for cell cultivation over the long run,” said Dr. Joachim Kreuzburg, chief executive officer of Sartorius Stedim Biotech.
“Our successful sales and marketing alliance has shown that Sartorius Stedim Biotech and Wave are a perfect match. I am excited about being able to work together soon with SSB’s Cell Culture and Fluid Management teams under one group umbrella and to develop new, innovative cell culture solutions for our customers,” said Wave's majority shareholder, Marcel Röll.
The acquisition, subject to clearance by the antitrust authorities, is expected to close in December 2008. Financial terms were not disclosed.
Posted on October 31, 2008 @ 10:37 am
Rod Szarka has been appointed business development manager,
QSV Biologics Ltd. He will be responsible for new business in California. Mr. Szarka has more than16 years of experience in drug research and development and four years of business development experience with pharmaceutical clinical trials. Prior to joining the company he was manager of business development at Global IQ. He spent several years with Cytovax Biotechnologies as laboratory research manager, where he was responsible for supervising, instructing and guiding research technicians in the microbiology, immunology and animal research unit. Mr. Szarka also spent time at ChemBioMed Ltd. and the Alberta Research Council.
Dr. Graeme Macaloney, QSV's president and chief executive officer, said, “Rod brings a strong ability to research potential companies and cultivate client relationships in the highly active California market for QSV. He couples this with a broad knowledge of protein, monoclonal antibody and vaccine drug development. Rod is a welcomed addition to the QSV Biologics team as he brings a professionalism and customer service ethic consistent with QSVs culture and reputation.”
Posted on October 30, 2008 @ 09:31 am
GlaxoSmithKline will acquire
Genelabs Technologies for approximately $57 million in cash. This acquisition is part of GSK’s effort to develop new therapies for hepatitis C virus (HCV). Genelabs will become part of GSK’s Drug Discovery organization and its HCV programs will be consolidated into GSK's therapeutic approaches already underway internally and through collaborations.
“Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus’s life cycle,” said Zhi Hong, senior vice president of the Infectious Diseases Centre for Excellence in Drug Discovery (ID CEDD) at GSK. “This arrangement, combined with our other collaborations, will give GSK a broad HCV drug discovery platform addressing novel targets and innovative therapeutic approaches.”
Fred Driscoll, president and chief executive officer of Genelabs, said, “This transaction provides our shareholders with certain value at a substantial premium to our stock price. Through the efforts of our experienced scientific staff and other employees, we have generated highly differentiated compounds with the potential to address unmet medical needs of people with the HCV infection. GSK’s world-class research and development organization will allow us to accelerate our strategic vision of providing novel treatments that deliver tremendous value for patients.”
Posted on October 30, 2008 @ 09:28 am
Aryo Nikopour has been named vice president of scientific and technical services, and
Greg McParland has been named chief operating officer at
Irvine Pharmaceutical Services. These changes were made to accommodate the company’s growth, as well as the anticipated launch of its new subsidiary, Avrio Biopharmaceuticals, in January 2009.
Mr. Nikopour has spent five years at Irvine and has more than 20 years of experience in the pharmaceutical industry. His previous positions — at organizations such as PPD, Alpharma (Actavis), Solvay Pharmaceuticals and Solvay Animal Health — have helped develop his expertise in a range of areas, including chromatographic method development and validation, extractables/leachables studies, and implementation of new technologies and capabilities such as inhalation/nasal, biopharmaceutical and structural chemistry. He also has experience in scientific staff management, quality control, stability testing and regulatory requirements.
Mr. McParland has more than 30 years of experience in the pharmaceutical and chemical industries. Prior to joining the company, he was chief executive officer of Girindus America, Inc., a member of Solvay Organics, where he lead the company through the transition to become a commercial operation focused on small molecule and oligonucleotide APIs. His additional leadership experience includes working at Cambrex Corp., Altergy Systems, NextPharma and Aerojet Fine Chemicals in the areas of operations, sales and marketing, strategic planning, process optimization, and mergers and acquisitions.
“We are looking forward to continued growth under the leadership of Aryo Nikopour and Greg McParland,” said Assad J. Kazeminy, chief executive officer and founder of Irvine Pharmaceutical Services. “I am confident they will lead us to even greater success as we expand and work to provide ever improving services to our clients.”
Posted on October 30, 2008 @ 09:23 am
Jubilant Organosys has strategically aligned its two entities, U.S.-based
HollisterStier Laboratories and Canada-based
Draxis Specialty Pharmaceuticals, and has assigned new leadership roles. The alignment is in an effort to leverage the strengths of these companies in the area of contract manufacturing of sterile injectables and non-sterile products and specialty pharmaceuticals. The unified operations will focus on R&D and product innovation for specialty pharmaceuticals, and will consolidate Jubilant’s sterile and non-sterile contract manufacturing with its multi-site capabilities.
Jean Pierre Robert has been appointed chief executive officer for the specialty pharmaceutical organization. He will be responsible for the radiopharmaceuticals business of Draxis as well as the allergy extracts business of HollisterStier.
Marcelo Morales has been appointed chief executive officer for contract manufacturing. He will have responsibility for the sterile injectables manufacturing arm of HollisterStier and the sterile injectable, semisolids and solid dose manufacturing operations of Draxis.
“This strategic realignment will enable us to drive value for our customers through synergistic operations and will offer exciting opportunities for all of us,” said Jubilant Organosys co-chairmen Shyam and Hari Bhartia.
Posted on October 29, 2008 @ 08:48 am
AMRI is expanding its multipurpose pilot plant facilities in Aurangabad, India for non-GMP manufacturing services to 1,000-liter scale capacity, which will allow the company to provide customized pilot scale materials. The new facility will serve as an extension to AMRI’s kilo lab capabilities in Hyderabad, which operates to 100 liters in scale. The plant's first production run is currently underway.
“We are pleased to offer another high value alternative to our customers seeking the cost benefit of doing business in Asia, but retaining the quality they expect from a U.S. based-organization. Separately, we look forward to realizing cost savings at our U.S. manufacturing operations by becoming our own provider for some raw materials, eliminating third party costs in both money and lead time. This expansion further demonstrates AMRI’s investment and focus in building a worldwide drug discovery and development platform,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D.
The company noted that certain plant production will be dedicated to making starting materials for the company’s U.S. manufacturing facilities, reducing the plant’s reliance on external resource providers.
Posted on October 29, 2008 @ 08:46 am
Nicholas Moore, Ph.D. has been named director of development and pharmacology, discovery R&D,
AMRI. Dr. Moore will be responsible for the company's internal R&D portfolio, including the progression of discovery phase programs and the guidance of emerging candidates toward clinical trials. Dr. Moore will report to
Bruce Sargent, Ph.D., vice president of discovery R&D.
Dr. Moore has more than 27 years of industrial experience in experimental pharmacology and drug development from early discovery through late clinical phases. Most recently, he was responsible for behavioral pharmacology at Lundbeck Research USA as an associate director in the neuroscience division. Prior to Lundbeck, Dr. Moore spent 23 years in neuroscience discovery research at the Lilly Research Center in roles of increasing responsibility. He has extensive knowledge of preclinical studies, product in-licensing, due diligence and laboratory animal science. While at Lilly he directed the preclinical studies required for the successful development and commercialization of schizophrenia drug Zyprexa.
“Dr. Moore’s skills and experience strengthen our R&D capabilities, helping us build on our existing platform which has already delivered an AMRI oncology compound into Phase I, and in collaboration with BMS, the nomination of two clinical candidates, one of which is currently enrolled into Phase I studies by BMS,” said Dr. Sargent.
Posted on October 29, 2008 @ 08:44 am
Wendy Shusko has been named chief operating officer of
WellSpring Pharmaceutical. In her new role, Ms. Shusko will maintain financial responsibilities as well as broaden her oversight to operations with an initial focus on the newly acquired consumer brands product line.
Ms. Shusko joined the company in 2000 and most recently served as chief financial officer. She has more than 20 years of experience in finance and operations, with 16 of those years in the pharmaceutical industry. From 1992 until joining the company, Ms. Shusko worked in various management and financial positions for Roberts Pharmaceutical, an international pharmaceutical company, including director of finance and financial operations.
"WellSpring's success thus far can be attributed to driven efforts toward a common vision. I am now asking Ms. Shusko to apply her experience and skills to operations with the anticipation that we will continue that trend in the years to come," said Dr. Robert A. Vukovich, WellSpring's chief executive officer and chairman.
Posted on October 28, 2008 @ 09:14 am
Laureate Pharma has entered into a cGMP contract manufacturing agreement with
Tolera Therapeutics, a biotechnology company that develops targeted therapies and safer solutions for immune modulation and related medical needs. Under the agreement, Laureate will produce Tolera's TOL101 monoclonal antibody under cGMP conditions to be used in clinical trials. Terms of the agreement were not disclosed.
"We are pleased to work closely with Tolera to accelerate their antibody therapeutics program to clinic," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate. "We are committed to providing Tolera with superior services to help them achieve their manufacturing objectives."
"We are excited to work with Laureate, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities in both clinical and commercial-grade materials can support our aggressive development and commercial plans," said John J. Puisis, president and chief executive officer of Tolera. "We look forward to our partnership with Laureate in utilizing their specialized experience in the manufacture of monoclonal antibodies."
Posted on October 28, 2008 @ 09:12 am
QSV Biologics Ltd. has formed an Australian subsidiary, QSV Biologics Australia Pty Ltd., and has appointed
Dr. Neville McCarthy to its board of directors.
Dr. Graeme Macaloney, founder and chief executive officer, said, “The formation of our Australian subsidiary demonstrates the commitment QSV has for the biopharmaceutical industry in Australasia. The addition of Dr. McCarthy, a founding statesman of the Australian biotech industry, including 17 years at the helm of CSL, brings tremendous experience of — and connectivity to — the Australian and regional industry. I am very pleased and excited to be working with such a gentleman and scholar.”
Dr. McCarthy is a medical scientist and an officer of the Order of Australia. His career encompasses the founding and operation of his own medical practice, serving as director with ER Squibb, managing director of Commonwealth Serum Laboratories (CSL), managing director and chairman of Chiron Mimotopes (Australia), chairman of Mabtech Ltd, chairman of Monash IVF Group, and director of Southern Medical Diagnostics Pty. Ltd.
Posted on October 28, 2008 @ 09:10 am
Avid Bioservices, Inc. has signed a manufacturing supply agreement with
Catalyst Biosciences to produce clinical-grade material for Catalyst's drug candidate, CB 813, a new version of factor VIIa for the treatment of acute bleeding in hemophilia patients.
Under the terms of the agreement, Avid will begin manufacturing drug supply under cGMP regulations and provide cell bank preparation, process development, and preparation of the manufacturing portion of the NDA. Further details were not disclosed.
“This agreement with Catalyst Biosciences for their lead clinical candidate is the most recent example of the traction we are gaining as a trusted provider of cGMP manufacturing services, as well as our broad capabilities as a provider of valuable ancillary services," said Steven W. King, president of Avid. "We are delighted to be working with the talented Catalyst team and their promising engineered protease technology.”
"Avid's expertise in the scale-up and manufacture of clinical-grade biotechnology therapeutics and their strong customer orientation made them a good choice for Catalyst,” said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences.
Posted on October 27, 2008 @ 09:27 am
Bilcare Global Clinical Supplies has expanded its global distribution and warehousing capabilities for clinical trial supplies. The company has signed a service agreement with World Courier to use depots in Argentina, Brazil, Colombia, Chile, Mexico, Peru, and Russia. The new locations add to Bilcare's existing locations in India, UK, Singapore and the U.S. The company plans to add more global depot locations in the near future.
As a result of working with World Courier, Bilcare will be able to enhance its capabilities globally, to receive, control, verify and store client materials in temperature-controlled facilities providing specialty storage conditions, pick-and-pack handling, and certified delivery to client-designated locations, according to a company statement.
"With the drug discovery program leading to potential new drugs becoming more complex, the need to clinically test drug efficacy and safety in diverse population groups across multiple geographic regions is becoming a crucial necessity. This necessity is driving clinical trials to be conducted at multiple locations across the globe," said Mohan Bhandari, chairman and managing director of Bilcare Ltd.
Posted on October 27, 2008 @ 09:26 am
Cipher Pharmaceuticals has appointed
John MacInnis as vice president, portfolio development and licensing. Mr. MacInnis will be responsible for identifying and evaluating pipeline products and technologies, and pursuing strategic alliances and partnerships for the company's drugs in targeted markets.
Mr. MacInnis has experience in the life sciences industry with expertise in large global pharmaceutical, private equity and portfolio management consulting. Most recently, he was vice president, business development at Kromite, a consulting firm that offers strategic support to life science companies, including technical risk assessment and benchmarking, forecasting, licensing support, portfolio and resource optimization and strategic planning. He held the position of executive vice president, business development at DRI Capital, where he was responsible for the identification and evaluation of life science royalty financing opportunities. Previously, he served as director, disease area strategy within Novartis Global Marketing (Basel), and executive director, CNS Franchise within the strategic marketing group at Johnson and Johnson.
"We are very pleased to welcome John to the team," said Larry Andrews, president and chief executive officer of Cipher Pharmaceuticals. "His global new product and business development knowledge, private equity experience and complementary skill set will be highly beneficial in our pursuit of new product opportunities and additional partnerships for our current late-stage portfolio."
Posted on October 27, 2008 @ 09:22 am
Celgene has terminated its licensing agreement with
MethylGene for oncology histone deacetylase (HDAC) inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. MethylGene also announced plans to implement a strategic initiative to focus its resources on the clinical development of its pipeline.
As part of the termination, Celgene will continue to support MGCD0103 for 90 days to help with the transition. Celgene acquired the rights to MGCD0103 through its March 2008 acquisition of Pharmion Corp. MethylGene now owns the worldwide rights to MGCD0103 (with the exception of certain Asian territories), MGCD265 and MGCD290, all of which are at various stages of clinical development.
"We believe regaining exclusive rights to MGCD0103 will allow MethylGene to accelerate submissions to the FDA aimed at lifting the partial clinical hold for MGCD0103," said Donald F. Corcoran, president and chief executive officer of MethylGene. "We believe that MGCD0103 represents a promising opportunity for the treatment of cancer and has demonstrated clinical activity in a number of tumor types evaluated to date. With MGCD0103 back in MethylGene's hands, upon successful lifting of the partial clinical hold, we will evaluate the funding requirements, development pathway, partnerships and alternative arrangements needed to potentially move the program forward."
MethylGene also announced it will discontinue its discovery research activities. The first phase of the reduction will occur during the next two months with additional reductions planned during 2009 as funded discovery research with Celgene and Otsuka Pharmaceutical are concluded. It is expected that approximately half of the company's staff of 109 full-time employees will be affected by the transition.
"We are aligning the organization toward our development opportunities in order to better realize the value of our proprietary clinical pipeline. By streamlining the organization to focus on development, we expect to extend our current cash resources and progress our clinical pipeline toward nearer term value enhancing milestones," said Mr. Corcoran. "Decisions such as this are difficult. We are a company that has grown due to the talent, hard work and expertise of our employees and we greatly appreciate their contributions. We owe it to our colleagues and to our shareholders to seek success in the clinical development and ultimate commercialization of our lead compounds.”
Posted on October 24, 2008 @ 09:11 am
GlaxoSmithKline Biologicals (a GSK unit) and
AFFiRiS GmbH have entered a collaboration agreement granting GSK exclusive rights to AFFiRiS's Alzheimer's disease vaccine programs that target beta-amyloid. GSK is acquiring exclusive rights to develop and commercialize two vaccine candidates currently in Phase I development that are based on AFFiRiS AFFiTOPE technology. GSK also has an exclusive option to develop and commercialize alternative Alzheimer's vaccine candidates in preclinical development.
Under the terms of the agreement, AFFiRiS will receive an up-front payment of $28.8 million and is eligible for future milestone payments and royalties. The total potential value of the agreement could reach $551.3 million in the event of full commercial success of the candidate vaccines. This agreement is subject to government approval.
AFFiRiS AFFiTOPE technology allows the design of proteins with very specific binding characteristics that are ideally suited for the development of vaccines against disease-causing "rogue" human proteins such as beta-amyloid, which is central to the pathology of Alzheimer's disease.
Walter Schmidt, co-founder and chief executive officer of AFFiRiS, said, "We are pleased that we could secure GSK Biologicals, one of the world's leading vaccine companies, in collaborating on the development our Alzheimer's disease vaccine programs. This deal brings together two companies with strong innovation, vaccine development and commercialization capabilities and experience."
Posted on October 24, 2008 @ 09:10 am
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a NDA to the FDA for carisbamate, an investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
The filing is supported by data from three placebo-controlled trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.
In 1999, J&JPRD and SK Holdings Co. entered into a license agreement to develop and commercialize carisbamate under which J&JPRD received global marketing rights. If approved, carisbamate will be marketed by Ortho-McNeil Neurologics under the brand name Comfyde.
Posted on October 24, 2008 @ 09:08 am
Elan
3Q Revenues: $270.1 million (+53%)
3Q Loss: $83.5 million (loss of $87.4 million in 3Q07)
YTD Revenues: $730.4 million (+35%)
YTD Loss: $240.5 million (loss of $321.5 million in YTD07)
Comments: Biopharmaceuticals business grew by 85% driven by a strong performance from Tysabri, with Elan’s recorded sales up 159% to $164.5 million. Total in-market sales of Tysabri were $237.0 million in the quarter (+154%). Azactam sales were $24.2 million (+17%). Maxipime sales were $5.7 million down from $19.2 million in 3Q07. R&D expenses were $90.0 million in the quarter (+53%) primarily related to the advancement of the company’s Alzheimer’s disease programs in the clinic. Revenue from the Elan Drug Technologies (EDT) business was up 3% to $71.2 million. Manufacturing revenue and royalties totaled $67.5 million and total contract revenue was $3.7 million in the quarter. Due to uncertainty in the financial and credit markets, Elan has decided to hold onto the EDT business and allow it to develop and grow as an independent, wholly-owned subsidiary. Potential generic competition looms for several of the products from which Elan earns manufacturing revenue and royalties.
Posted on October 23, 2008 @ 09:53 am
Patheon has opened a new Pharmaceutical Development Services (PDS) suite at its Whitby Development Center in Canada for the small-scale development and manufacturing of solid dosage forms for early clinical studies.
The 2,500-sq.-ft. suite, as well as the facility, are GMP-compliant for manufacturing products for Phase I and II clinical studies. The suite will contribute to Patheon's Quick To Clinic offering for First Time in Human (Phase I) studies. The new facility will also add early-phase pharmaceutical development and manufacturing capacity, with a manufacturing scale of 1kg to 10kg. The suite has multiple labs with the capability for small-scale dosage form development, as well as the manufacture of powder-in-bottle, tablets (immediate and modified release), capsules, oral liquids, and nasal sprays.
Colin Minchom, Ph.D., vice president, PDS, Canada, said, "We're very excited about the rapid response capabilities of the new Whitby suite. This new facility will significantly strengthen Patheon's competitiveness in the pharmaceutical and biotechnology early development arena."
Terry Novak, president, North America and chief marketing officer, added, "Patheon is committed to investing in its development services business and with this new capacity in Whitby; we can now offer rapid early phase development to our North American customers."
Posted on October 23, 2008 @ 09:52 am
Amgen
3Q Revenues: $3.9 billion (+7%)
3Q Earnings: $1.2 billion (earnings were $201 million in 3Q07)
YTD Revenues: $11.3 billion (+3%)
YTD Earnings: $3.2 billion (+39%)
Comments: Sales of Aranesp were up 3% to $845 million. Sales of Epogen increased 5% to $634 million. Combined sales of Neulasta and Neupogen were up 8% to $1.2 billion. Sales of Enbrel were $893 million (+9%). Sales of Sensipar increased 32% to $161 million. R&D expenses were $729 million in the quarter (-6%). Earnings in 3Q07 were negatively impacted by $590 million of acquired in-process R&D related to the acquisitions of Alantos Pharmaceutical Holdings and Ilypsa, Inc., as well as $293 million of restructuring charges.
Posted on October 23, 2008 @ 09:50 am
Lilly
3Q Revenues: $5.2 billion (+14%)
3Q Loss: $465.6 million (earnings were $926.3 million in 3Q07)
YTD Revenues: $15.2 billion (+13%)
YTD Earnings: $1.6 billion (-26%)
Comments: Zyprexa sales were $1.2 billion in the quarter (+2%). Cymbalta sales were $716.4 million (+40%). Gemzar sales were $440.2 million (+12%). Humalog sales were up 19% to $432.6 million. Cialis sales were $376.6 million (+21%). Alimta sales were $313.9 million (46%). Strattera sales were $149.5 million (+15%). Byetta sales were $201.2 million (+22%). R&D expenses were $953.0 million in the quarter (+13%). The 3Q08 loss was due to charges totaling $1.5 billion related to pending and resolved Zyprexa investigations. In the quarter, the company completed the $64.0 million acquisition of SGX Pharmaceuticals, a San Diego-based biotechnology company.
Posted on October 23, 2008 @ 09:42 am
Bristol-Myers Squibb
3Q Revenues: $5.3 billion (+14%)
3Q Earnings: $2.6 billion (earnings were $858 million in 3Q07)
YTD Revenues: $15.3 billion (+17%)
YTD Earnings: $4.0 billion (+74%)
Comments: Pharmaceutical sales were up 15% to $4.5 billion in the quarter. Growth was driven by strong performance from Plavix, Abilify, the HIV and hepatitis portfolio, as well as Orencia. Plavix sales were $1.4 billion in the quarter (+15%). Abilify sales were $564 million (+34%). Sustiva Franchise sales were $294 million (+24%). Reyataz sales were $342 million (+25%). Orencia sales were up 98% to $119 million. Avapro/Avalide sales were $334 million (+8%). Baraclude sales were up 100% to $144 million. Earnings include a $2.0 billion after-tax gain attributed to the sale of the company’s ConvaTec business. R&D expenses were up 4% to $834 million in the quarter.
Posted on October 22, 2008 @ 10:10 am
Merck plans to eliminate 7,200 jobs by the end of 2011 as part of a new restructuring program aimed at lowering overhead and becoming more competitive. As part of the program, Merck will streamline management layers by eliminating about 25% of senior and mid-level executives. The company currently employs about 56,700 people. The new job cuts are in addition to the 2005 restructuring program that eliminated 10,400 jobs.
According to a company statement, the new job cuts are expected to produce savings of $3.8 billion to $4.2 billion from 2008 to 2013 and will cost between $1.6 billion and $2.0 billion through the end of 2011, when the program is expected to be complete.
Posted on October 22, 2008 @ 10:09 am
Merck
3Q Revenues: $5.9 billion (-2%)
3Q Earnings: $1.1 billion (-28%)
YTD Revenues: $17.8 billion (-1%)
YTD Earnings: $6.2 billion (+26%)
Comments: Januvia sales were $379 million in the quarter (+105%). Sales of Isentress were $107 million. Worldwide sales of Singulair were $1.0 billion (+1%). Cozaar and Hyzaar sales were $888 million (+9%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.1 billion in the quarter (-15%). Worldwide sales of the Gardasil were $401 million (-4%). R&D expenses were $1.2 billion in the quarter (-19%). Restructuring costs, primarily related to employee separation costs associated with the company's global restructuring programs, were $757 million in the quarter and $49 million in 3Q07.
Posted on October 22, 2008 @ 10:08 am
Wyeth
3Q Revenues: $5.8 billion (+5%)
3Q Earnings: $1.1 billion (flat)
YTD Revenues: $17.5 billion (+5%)
YTD Earnings: $3.5 billion (-4%)
Comments: Pharmaceutical sales in the quarter were $4.9 billion (+5%) driven by Enbrel, Prevnar and Nutritional products, as well as the favorable impact of foreign exchange. This was partially offset by lower sales of Protonix. Also contributing to revenue growth were new products, Tygacil, Torisel and Pristiq. Enbrel sales (outside U.S. and Canada) were $697 million (+32%). Enbrel alliance revenue (U.S. and Canada) was $294 million (+23%). Prevnar sales were $717 million (+13%). Sales of Protonix products were $234 million (-45%). R&D expenses in the quarter were flat at $793 million.
Posted on October 22, 2008 @ 10:06 am
Amylin Pharmaceuticals and
Lilly have entered into a product supply agreement for exenatide once weekly, a compound under development to treat type 2 diabetes. Under terms of the agreement, Amylin will receive an initial cash payment of $125 million and Amylin will supply product for sales in the U.S. and to Lilly for sales outside of the U.S. Lilly will also reimburse Amylin for its share of the $500-plus million capital investment in the West Chester, OH facility through the cost of goods sold for exenatide.
As part of the overall supply pact, Lilly will make available to Amylin a $165 million line of credit that Amylin can draw upon beginning in 4Q09 through 2Q11.
"Amylin and Lilly continue to strengthen our exenatide alliance, building on the success of Byetta, our first-in-class medicine that has been used by approximately 1 million patients worldwide," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "With this agreement, we acknowledge Amylin's commitment in making this important investment to build critical manufacturing capacity."
"The state-of-the art manufacturing facility in Ohio is readying for full-scale commercial manufacturing of exenatide once weekly," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals. "This agreement strengthens our balance sheet and provides us with financial flexibility in the future, while moving us closer to our goal of bringing exenatide once weekly to patients as quickly as possible."
Posted on October 21, 2008 @ 03:13 pm
Pfizer
3Q Revenues: $12.0 billion (flat)
3Q Earnings: $2.3 billion (earnings were $761 million in 3Q07)
YTD Revenues: $36.0 billion (+1%)
YTD Earnings: $7.8 billion (+45%)
Comments: Pharmaceutical revenues in the quarter were $11.0 billion (-1%). Lipitor revenues in the quarter dropped 1% to $3.1 billion. Zyrtec and Camptosar revenues decreased by $549 million to $428 million and $121 million, respectively, impacted by the loss of U.S. exclusivity. Lyrica revenues were $675 million (+45%). Celebrex revenues were $625 million (+8%). Sutent revenues were $226 million (+49%). Chantix revenues were down 24% to $182 million. R&D expenses in the quarter were $1.9 billion (-6%). Results for 3Q07 and YTD07 include charges associated with the impairment of Exubera assets and the decision to exit Exubera, including $1.1 billion of intangible asset impairments, $661 million of inventory write-offs, $454 million of fixed asset impairments, and $584 million of other exit costs.
Posted on October 21, 2008 @ 03:11 pm
Schering-Plough
3Q Revenues: $4.6 billion (+63%)
3Q Earnings: $589.0 million (-21%)
YTD Revenues: $14.2 billion (+58%)
YTD Earnings: $1.3 billion (-29%)
Comments: Pharmaceutical sales were $3.5 billion in the quarter (+54%) driven by Remicade sales, up 32% to $564 million, and Temodar sales, up 27% to $273 million. Nasonex sales were up 6% to $258 million. Sales of Pegintron were $235 million (+6%). Revenues for the quarter also benefited from the inclusion of $896 million of OBS product sales and a favorable impact from foreign exchange. Sales of the global cholesterol joint venture with Merck, which include Vytorin and Zetia, totaled $1.1 billion in the quarter (-15%). Schering-Plough does not record these sales in its revenues; sales from the JV are accounted for under the equity method, impacting earnings directly. R&D expenses were $893 million in the quarter (+33%), which includes a $20 million upfront R&D payment. Earnings exclude purchase accounting adjustments, special and acquisition-related items, a $160 million pre-tax gain from the divestitures of certain animal health products and $19 million of income from the termination of the respiratory joint venture with Merck.
Posted on October 21, 2008 @ 03:09 pm
Biogen Idec
3Q Revenues: $1.1 billion (+38%)
3Q Earnings: $207 million (+74%)
YTD Revenues: $3.0 billion (+33%)
YTD Earnings: $576.5 million (+32%)
Comments: Tysabri sales recorded by Biogen, based on its collaboration with Elan, were $171 million (+172%) in the quarter. This consisted of $56 million related to product sold through Elan in the U.S. (based on $122 million of in-market sales); and $115 million related to product sold by Biogen internationally. Avonex sales were up 26% to $573 million. Rituxan sales were up 27% to $299 million (co-marketed in the U.S. with Genentech). R&D expenses were $269 million in the quarter (-6%).
Posted on October 21, 2008 @ 09:02 am
Azopharma Product Development Group has entered the microdosing market and will provide services to synthesize material open to microdose studies as well as formulate and administer microdoses in a clinical setting, and analyze samples.
Microdosing involves the use of radiolabeled materials at very low levels where patients are dosed at 1/100 of the anticipated therapeutic dose. Samples are then analyzed with an Accelerate Mass Spectrometer (AMS), which is capable of detecting the labeled compound at 10-21 mole levels. The extremely low dose levels minimize potential toxic effects in humans while providing pharmacological data, which may not be found in animal research. Microdosing is important among pharmaceutical and regulatory agencies and enables the industry to save time and money on development processes by receiving early PK and ADME data in humans.
Phil Meeks, chief executive officer of Azopharma Product Development Group said, “This new service is a natural extension of our current business model. We are already a leader in the formulation and clinical trial fields. This gives our clients a new option in their development process. Due to the improved safety and potential gains in development timelines, we foresee this technology becoming a key part of the drug development process.”
Posted on October 21, 2008 @ 09:01 am
Laureate Pharma has entered into a cGMP contract manufacturing agreement with
Tolerx, Inc. to produce Tolerx's humanized anti-GITR antibody known as TRX518, which is currently in development for cancer and chronic viral indications. Details of the agreement were not disclosed.
"The partnership with Tolerx validates the progress we have made in biomanufacturing and our commitment in helping our clients bring novel therapies to the market," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "With our well-established monoclonal antibody experience, we will partner closely with the Tolerx team to help them achieve their manufacturing objectives."
"Laureate Pharma has a proven track record in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials," said Dr. Douglas J. Ringler, president and chief executive officer of Tolerx. "This agreement enables us to operationally leverage Laureate's expertise and infrastructure while we seek to establish new treatment paradigms in the immunology space."
Posted on October 21, 2008 @ 08:59 am
Shabbir Anik, Ph.D. will join
Althea Technologies as president and chief executive officer. Dr. Anik will lead the company's expansion of its product development, clinical trial and commercial manufacturing services.
"We are delighted to welcome Dr. Anik to Althea and feel that his background and expertise is a wonderful match for the company," said Dr. Magda Marquet, co-chair of Althea Technologies. "He is a rare blend of scientist, manager and leader, and we are excited about Althea's continued success with Shabbir at the helm. . . As we continue to grow to serve our clients, Shabbir's experience in manufacturing, his understanding of the critical interplay of services in bringing a product to commercial success, and his ability to manage these activities across the globe will be invaluable to Althea."
Dr. Anik previously served as president of Pharmaceutical Development Services (PDS) at Patheon, Inc., where he was responsible for building and managing the company's global PDS business. He also served as senior director of Pharmaceutical Development and Operations for the biotechnology company Neurex. Dr. Anik began his career at Syntex, serving in positions of increasing responsibility, including serving as vice president and program director.
Posted on October 20, 2008 @ 09:04 am
Pfizer and UCB have formed a new technology company, Cyclofluidic, established with the goal of accelerating the drug discovery process by allowing researchers to test a broader range of potential new drug in less time. The UK Government’s Technology Strategy Board helped to facilitate this arrangement between the two companies and will continue to support Cyclofluidic by co-funding its R&D. The new company will be jointly owned by Pfizer and UCB.
Cyclofluidic’s goal is to develop technologies that automate and integrate processes known as flow chemistry and flow biology to help pharmaceutical companies shorten timelines within the drug development process. Through extensive collaboration with key academics and component manufacturers, Cyclofluidic plans to develop a microfluidic closed loop lead optimization platform that will enable researchers to access expertise in flow chemistry, flow screening and microfluidic engineering. Cyclofluidic will also provide training for both flow chemistry and biology scientists at its facility located in the South of England.
Iain Gray, chief executive officer of Technology Strategy Board, said, “Our role is to stimulate the development and deployment of technologies which, as well as benefiting society, also provide global business opportunities for the UK. Cyclofluidic is an excellent example of the private and public sectors working together to develop world-leading technologies which have the potential to bring enormous benefit to patients in the and around the world. We are delighted to offer our support and investment."
“Cyclofluidic’s entry into the rapidly evolving microfluidic technology area has the potential to radically transform the medicinal chemistry and biology interface,” said Dr. Neil Weir, senior vice president of research at UCB. “It’s an exciting opportunity for UCB and Pfizer to collaborate and offers real potential for improved productivity, underlining our commitment to innovation for patients.”
Posted on October 20, 2008 @ 09:01 am
Novartis AG is restructuring the management of three of four business units, with plans to cut 550 marketing jobs in an effort to save $80 million annually starting in 2010, according to Joerg Reinhardt, head of the vaccines unit and chief operating officer. The restructuring is part of chief executive officer Daniel Vasella's plan to thwart losses of its best-selling drug Diovan due to generic competition.
Thomas Ebeling, head of the consumer health unit, is leaving the company and will be replaced by George Gunn, currently head of the animal health division. Mr. Reinhardt's position will be filled by Andrin Oswald, chief executive of Speedel AG, which was acquired by Novartis earlier this year. Andreas Rummelt, head of the Sandoz generic drugs division, will be replaced by Jeff George, who leads emerging markets. Mr. Rummelt will head quality assurance. David Epstein, head of the oncology division, will also oversee a new unit focusing on molecular diagnostics. Mr. Vasella has reached an agreement with the board to extend his contract, according to a Novartis statement.
The company also plans to cut its sales force and concentrate on marketing drugs to managed care organizations instead of selling to general practitioners.
Posted on October 20, 2008 @ 08:57 am
Novartis
3Q Revenues: $10.7 billion (+12%)
3Q Earnings: $2.1 billion (+32%)
YTD Revenues: $31.4 billion (+12%)
YTD Earnings: $6.7 billion (+19%)
Comments: Pharmaceutical sales were $6.7 billion in the quarter, up 14% (9% in local currencies). Growth was driven by the oncology and cardiovascular franchises as well as $800 million in sales from recently launched products, Lucentis, Aclasta/Reclast, Exforge, Tekturna/Rasilez, Exjade and Exelon Patch. Oncology sales were $2.1 billion (+15% lc) driven by Gleevec/Glivec with $950 million in sales (+15% lc), Zometa with $360 million in sales (+9% lc) and Femara with $289 million in sales (+16% lc). Cardiovascular sales were $1.7 billion (+20% lc), driven by the new high blood pressure medicines Tekturna/Rasilez and Exforge as well as Diovan ($1.4 billion, +9% lc). Vaccines and diagnostics sales were up 16% to $666 million (+14% lc). Sandoz revenues were $1.9 billion, up 7% (flat in local currencies). 2007 results included an incremental environmental provision charge of $590 million to cover worldwide remediation plans.
Posted on October 17, 2008 @ 09:00 am
Gilead Sciences
3Q Revenues: $1.4 billion (+30%)
3Q Earnings: $504 million (+27%)
YTD Revenues: $3.9 billion (+25%)
YTD Earnings: $1.4 billion (+19%)
Comments: The company achieved record revenues in the quarter. Growth was driven by the company’s antiviral franchise, with sales up 39% to $1.2 billion, including strong performances by Atripla and Truvada, with sales up 77% to $427.6 million and 34% to $549.1 million, respectively. Viread sales were $156.0 million in the quarter (+5%). Sales of Hepsera increased 15% to $91.2 million, driven primarily by a favorable foreign exchange impact and sales growth in North America and certain European markets. Sales of AmBisome were up 6% to $72.9 million. Royalty, contract and other revenues were $32.8 million, down 66% due to lower Tamiflu royalties from Roche ($8.6 million in 3Q08 compared to $77.4 million in 3Q07). R&D expenses were $188.1 million in the quarter (+34%).
Posted on October 17, 2008 @ 08:58 am
Valeant Pharmaceuticals International has concluded its exclusive worldwide collaboration agreement with
GlaxoSmithKline for retigabine, an investigational drug for the treatment of adult epilepsy patients with refractory partial onset seizures. Under the terms of the agreement, Valeant received an upfront payment of $125 million from GSK.
Posted on October 17, 2008 @ 08:56 am
Catalent Pharma Solutions received notice that the FDA has approved the sale of a prescription product manufactured at its recently opened pre-filled syringe facility in Brussels, Belgium. Syringes from the Brussels facility will likely be dispensed to patients in the U.S. during the next few months.
Richard Yarwood, group president of Catalent’s Sterile Technologies segment, said, “We are very pleased to have reached this important milestone in the evolution of our Brussels facility, and to further extend our strategic partnership with this customer. With this first FDA product approval, we are even more strongly positioned to help our customers satisfy the fast growing U.S. market demand for drugs and biologics in the prefilled syringe format.”
Posted on October 16, 2008 @ 09:11 am
Abbott
3Q Revenues: $7.5 billion (+18%)
3Q Earnings: $1.1 billion (+51%)
YTD Revenues: $22.0 billion (+15%)
YTD Earnings: $3.3 billion (+39%)
Comments: Worldwide pharmaceutical sales were $4.1 billion in the quarter (+17%), driven by growth in Humira, Kaletra, TriCor, and Niaspan. U.S. sales were $3.7 billion (+18%). International sales were $2.0 billion (+22%) with a positive impact of exchange of 10%. Humira sales reached $1.2 billion in the quarter (+50%). Kaletra sales were $387 million (+14%). TriCor sales were up 11% to $334 million. Niaspan sales were up 16% to $194 million. Depakote sales were down 17% to $317 million due to generic competition. Worldwide vascular sales were $636 million in the quarter (+58%). Coronary stents accounted for $383 million (+135%).
Posted on October 16, 2008 @ 09:08 am
WuXi PharmaTech, Inc. has reached an agreement with
Johnson & Johnson Pharmaceutical R&D, Division of Janssen Pharmaceutica, N.V. (J&JPRD) to expand its pharmaceutical R&D services collaboration. In addition to providing discovery chemistry services WuXi, will now also provide research services in the area of discovery biology, chemical and analytical development services, formulation, and preclinical and bioanalytical services, under the new agreement.
Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, said, "We are very pleased to expand our partnership with J&JPRD. This agreement leverages WuXi's strong R&D capabilities from early stage discovery to commercial production to deliver reliable, high quality and cost-efficient services to J&JPRD. Our partnership demonstrates the strength of our innovation driven and fully integrated R&D service platform."
Posted on October 16, 2008 @ 09:07 am
Charles River Laboratories International opened its 60,000-sq.-ft. preclinical facility in Shanghai. The new facility is aimed at fostering growth in that emerging market by assisting global and local biopharmaceutical companies with their drug development programs. The new facility is expected to provide Good Laboratory Practice (GLP) services in the first quarter of 2009.
The China facility will provide a range of services that are compliant with regulatory agencies including: Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Canadian Council on Animal Care (CCAC), China’s State Food and Drug Administration (SFDA), Organization for Economic Cooperation and Development (OECD), and the FDA.
“As our clients make their initial forays into China, we are creating a center of excellence that embodies global best practices alongside them,” said James C. Foster, president, chairman and chief executive officer of Charles River. “Our clients have come to appreciate and rely on the expertise Charles River brings to their drug development efforts, and the convenience of our facilities in close proximity. The same high standards of research, safety, humane care and good laboratory practices that globally distinguish Charles River are replicated in our Shanghai facility.”
Posted on October 15, 2008 @ 09:15 am
Catalent Pharma Solutions has opened a new temperature controlled warehouse in Bolton, UK to meet increased demand for clinical supply services, particularly cold-chain storage and distribution. “The opening of the warehouse further enhances Catalent’s ability to support the global clinical trial requirements of our customers,” said Frank Lis, vice president and general manager of Global Clinical Supplies for Catalent.
The new 11,800-sq.-ft. warehouse is an extension of the existing facility and is fully operational. The temperature controlled warehouse has 2,000 controlled ambient storage locations and a 320-pallet refrigerator.
Posted on October 15, 2008 @ 09:13 am
Genentech
3Q Revenues: $3.4 billion (+17%)
3Q Earnings: $731 million (+7%)
YTD Revenues: $9.7 billion (+11%)
YTD Earnings: $2.5 billion (+17%)
Comments: U.S. product sales were $2.5 million in the quarter (+14%). Avastin sales were $704 million (+18%). Rituxan and Herceptin sales were both up 15% in the quarter to $655 million and $368 million, respectively. Lucentis sales were $225 million (+14%) and Xolair sales were $136 million (+12%). R&D expenses were $777 million in the quarter (+26%). Royalty revenue was $687 million (+31%) due to growth in royalties from sales outside the U.S. by licensees. Results in the quarter were impacted by a $44 million expense related to employee retention programs in response to the Roche proposal to acquire outstanding Genentech shares; a $105 million expense related to a collaboration agreement with GlycArt and Roche; and a $67 million expense related to the “impairment of certain assets in the company’s investment portfolio.”
Posted on October 15, 2008 @ 09:11 am
Tegrant Corp. created a new joint venture to market its ThermoSafe products in the Asia Pacific region. ThermoSafe Brands Asia will operate as a JV between Tegrant and FEC Corp., a Hong Kong-based investment company focused on the Asian packaging market. FEC operates nine factories across China and Malaysia through its subsidiary Kingpak Packaging Group. The venture will manufacture and distribute temperature assurance products across the Southeast Asian region. ThermoSafe Brands Asia will be headquartered in Singapore.
"We are pleased to have formed our joint venture with such an esteemed company as FEC, whose expertise in packaging is well-known in Asia. Southeast Asia has been identified as a high growth priority for ThermoSafe Brands, and we have an immediate need to supply Temperature Assurance Products to current customers in the region,” said Ron Leach, president and chief executive officer of Tegrant Corp.
Colleen Bohn, president of ThermoSafe Brands, said, “I am excited about what this new venture means for ThermoSafe and its customers. We will now be able to produce common products for our customers in the U.S. and Asia and ensure that they are manufactured with the same quality standards and specifications. Additionally, we will serve our customers with a local sales and support team in Asia that has full access to our state-of-the-art design and testing capabilities.”
Posted on October 14, 2008 @ 09:49 am
Johnson & Johnson
3Q Revenues: $15.9 billion (+3%)
3Q Earnings: $3.3 billion (+30%)
YTD Revenues: $48.6 billion (+8%)
YTD Earnings: $10.2 billion (+25%)
Comments: Worldwide Pharmaceutical sales were flat at $6.1 billion in the quarter, with an operational decline of 2.5% and a positive impact from currency of 2.7%. Domestic sales were down 6%, while international sales increased 10% (3% from operations and 7% from currency). Velcade, Remicade, Topamax and Risperdal Consta performed well in the quarter. Velcade sales were $190 million (+46%); Remicade sales were $978 million (+19%); Topamax sales were $728 million (+19%); Risperdal Consta sales were $338 million (+15%). Sales of Risperdal were down 63% to $320 million due to generic competition. Worldwide Consumer sales were $4.1 billion in the quarter (+13%). Worldwide Medical Devices and Diagnostics sales were $5.7 billion (+9%). 3Q07 included an after-tax restructuring charge of $528 million associated with a cost improvement program.
Posted on October 14, 2008 @ 09:48 am
Akorn, Inc. has entered into a five-year supply agreement with an undisclosed ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of the ophthalmic product, for which it holds the ANDA. Revenues from this agreement are expected to begin in early 2009.
Arthur S. Przybyl, Akorn’s president and chief executive officer, stated, “We continue to grow our contract manufacturing services and are pleased to announce this new long-term partnership. During 2008, Akorn’s contract manufacturing business has expanded to include four new ophthalmic and two new injectable partnerships. To date, two ophthalmic partnerships are generating revenue, one injectable partnership is expected to launch in October 2008, and the remaining partnerships will begin generating revenue in 2009.”
Posted on October 14, 2008 @ 09:46 am
Schwarz Pharma Manufacturing, Inc., a unit of Schwarz Pharma AG of Monheim, Germany, announced a $12 million expansion of its Seymour, IN manufacturing plant and distribution center. As a result of this expansion, the company expects to add 150 employees for a total of 516 by 2011. The company plans to begin hiring managers, business associates and production staff later this month.
The 280,000-sq.-ft. facility handles manufacturing for all of the company's products sold in the U.S., including blood pressure medication Univasc.
Posted on October 13, 2008 @ 08:26 am
Genmab has reached the sixth milestone in its collaboration with
GlaxoSmithKline for ofatumumab (HuMax-CD20), as the first patient received treatment in the Phase I study of ofatumumab in relapsed/refractory follicular non-Hodgkin's lymphoma and chronic lymphocytic leukemia in Japan. The milestone payment was approximately $5.6 million.
Ofatumumab is an investigational, new generation, human MAb that targets a distinct membrane proximal, small loop epitope of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis.
Posted on October 13, 2008 @ 08:22 am
Paul K. Wotton, Ph.D., has been named president and chief executive officer of
Antares Pharma. Dr. Wotton previously served as president and chief operating officer, the titles he held upon joining the company in July 2008. Concurrently, Jack E. Stover has resigned as both chief executive officer and vice chairman of the board.
Dr. Wotton previously served as chief executive officer of Topigen Pharmaceuticals, following a stint as head of global business development at SkyePharma, as well as senior level positions at Eurand, Penwest Pharmaceuticals, Abbott, Merck, Sharp and Dohme.
Commenting on his new responsibilities, Dr. Wotton said, “I look forward to building shareholder value at Antares. The depth of our product pipelines in both our pharma and parenteral device divisions as well as our key partnership activities provide near and long-term growth opportunities for our business and share price.”
Posted on October 10, 2008 @ 09:22 am
Abbott opened its new development labs and a pilot plant facility based in Ludwigshafen, Germany. The facility will research technologies and test large-scale production of newly developed drug formulations. The expansion is part of the company's global drug delivery business, SOLIQS.
"Abbott is committed to advancing scientific innovation and bringing new medicines to patients," said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. "Innovative drug formulation is critical to the development of effective new treatments that make a difference for patients."
"Nearly 40% of pharmaceutical compounds never reach the clinical study phase because they cannot be absorbed in the human body," said Jorg Breitenbach, Ph.D., senior director of drug product development and head of SOLIQS. "The SOLIQS expansion builds on Abbott's expertise in drug delivery technology and addresses the rising demand for innovative, patient-focused formulations."
The facility will evaluate new processes for its current technologies, Meltrex, Xellex, NanoMorph and smartCrystals that target the formulation of soluble complex pharmaceutical substances. Using the Meltrex technology for example, Abbott developed a new tablet formulation of its drug Kaletra that does not require refrigeration and can be taken with or without food. This tablet formulation also offers the convenience of fewer pills.
Posted on October 10, 2008 @ 09:19 am
Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
The agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. According to a Takeda statement, the FDA did not provide guidance as to when the review might be completed. If the FDA does not complete its review of the NDA by the end of the year, development partner PDD will not receive the $25 million alogliptin approval milestone in 4Q08. The NDA was submitted in December 2007 for the treatment of type 2 diabetes.
Posted on October 10, 2008 @ 09:16 am
CEL-SCI Corp. has taken delivery of the new manufacturing facility for its lead drug candidate Multikine. This facility, located in the Baltimore area, will produce Multikine for use in CEL-SCI's Phase III trial for first-line therapy of previously untreated head and neck cancer, and for manufacturing the drug upon approval. The facility cost about $22 million to build and will soon be commercially ready. Currently the facility can produce about $600 million worth of drug per year and can be built out to produce nearly $2 billion worth of drug product per year.
Geert Kersten, CEL-SCI's chief executive officer, said, "Having our own Multikine dedicated manufacturing facility gives us control and eliminates a great deal of risk from our product development. Our next step is to completely validate the facility and to bring it on line for manufacturing."
CEL-SCI's upcoming Phase III trial is an 800-patient study designed to demonstrate that administration of Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer affects about 650,000 people per year.
Posted on October 9, 2008 @ 08:49 am
Patheon has completed its expansion of services using a new Intermediate Scale Processing Suite (ISPS) at its Cincinnati, OH facility. The ISPS provides increased manufacturing capacity, bridging the company's development and commercial scale facilities.
The ISPS equipment includes an intermediate scale Diosna-P300 high shear granulator coupled with Niro-MP4 fluid bed dryer with solvent and high potency compound handling capabilities. This suite will allow the production of batch sizes ranging from 35-115 kg. The ISPS will allow the company to provide development, clinical, registration, scale-up, validation and commercial services to customers. The ISPS provides greater flexibility in scheduling experiments on a larger scale, using less active pharmaceutical ingredients (API) compared to commercial scale, according to the company.
Terry Novak, Patheon's president, North America and chief marketing officer, stated, "The ISPS provides us with another valuable service to address the unique needs of our customers. By adding this equipment we will be able to reduce time and resources it takes to moving a new product though development."
Posted on October 9, 2008 @ 08:47 am
Dr. Christophe Berthoux has been named executive vice president, global sales and marketing and chief commercial officer,
Charles River Laboratories. In this newly created position, Dr. Berthoux will lead the global realignment of the company's sales and marketing organization, with the goal of enhancing the company's interface with its customers.
"Given Dr. Berthoux's scientific and business training, his in-depth customer knowledge, as well as his considerable sales and marketing experience, I am confident that he will provide extraordinary levels of leadership in driving this newly created global organization," said James C. Foster, chairman, president and chief executive officer of Charles River.
Posted on October 9, 2008 @ 08:43 am
Muhammad Asif, Ph.D. has been named director of analytical development, and
Paul Maffuid, Ph.D. has been named senior vice president of operations,
Irvine Pharmaceutical Services.
Dr. Asif has more than 17 years of experience including supporting the development of pharmaceutical products through his various roles at MannKind Corp., DEY, L.P. (an associate of Merck KGaA), Wyeth, and Fujisawa, USA. His expertise ranges from analytical method development and validation to extractables/leachables, product characterization studies and preparation of analytical portions of the CMC sections of INDs, NDAs and ANDAs.
Dr. Maffuid has 20 years of experience in the pharmaceutical industry having worked at various companies, including Arena Pharmaceuticals, Inc., Magellan Laboratories, Inc., Cabrillo Laboratories, Amylin Pharmaceuticals, Inc., Glaxo research, California Biotechnology and Syntex, Inc. He is a member of the American Association of Pharmaceutical Scientists and the American Chemical Society, and has authored several publications.
Irvine Pharmaceutical Services welcomes Dr. Maffuid and Dr. Asif as part of the company's ongoing efforts to continually improve its client services through employment of unparalleled professionals. "I am proud to have Dr. Maffuid and Dr. Asif join our staff," said Assad J. Kazeminy, chief executive officer and founder of Irvine Pharmaceutical Services. "Each brings an impressive depth of knowledge and experience, which I am confident will prove invaluable to our current and future clients."
Posted on October 8, 2008 @ 09:13 am
Pfizer, as part of its strategy to improve growth, plans to reorganize its business units in an effort to better coordinate drug development and commercialization. These changes are part of chief executive officer Jeffrey Kindler's plan to "establish smaller operating units that can enhance innovation and accountability, but will draw upon the advantages of scale and resources Pfizer offers," said Raymond Kerins, a spokesman for Pfizer. The changes will take effect in January.
The reorganization will create three new units: primary care, specialty care and emerging markets. The primary-care unit will handle the drugs often prescribed by first-line doctors, such as the cholesterol treatment Lipitor. Specialty care will include drugs marketed to specialist doctors, such as anti-HIV drug Selzentry. The emerging-markets unit will handle the marketing of Pfizer drugs in emerging markets. The divisions will be responsible for drug development through sales and marketing. Research focused on the discovery of potential new drugs will continue to be handled by Pfizer's R&D arm, which is led by Martin MacKay.
Each unit will be led by a general manager who will report to Ian Read, president of worldwide pharmaceutical operations. Pedro Lichtinger, previously Pfizer's area president for European pharmaceuticals, will lead the new primary-care unit. Olivier Brandicourt will lead the specialty-care division. He was previously senior vice president of a unit focused on cardiovascular drugs. Jean-Michel Halfon will lead the new emerging-markets unit.
The reorganization plans do not include job cuts or changes to senior management, according to Mr. Kerins. The company previously created business units for oncology and established products. It also has an animal-health unit.
Posted on October 8, 2008 @ 09:10 am
Bridge Laboratories has been awarded a follow-on contract by the National Institute on Drug Abuse (NIDA). The five-year contract has an estimated value of $4.1 million if all options are exercised. Under the new contract, Bridge will provide toxicological evaluations for potential medications used to treat drug abuse.
“We appreciate the confidence NIDA has shown in Bridge Laboratories over the past five years and look forward to collaborating with them to find ways to significantly improve prevention, treatment, and policy as it relates to drug abuse and addiction,” said Tom Oakley, president and chief executive officer, Bridge Laboratories.
Posted on October 8, 2008 @ 09:09 am
Millipore Corp. opened a new membrane casting manufacturing facility in Carrigtwohill, County Cork, Ireland. The 30,000-sq.-ft. facility nearly doubles the company’s membrane production capabilities in Ireland.
“Millipore is celebrating 20 years in Cork. By opening this new facility, we are illustrating our strong commitment to continue our work in Ireland,” said Millipore's chairman, president, and chief executive officer, Martin Madaus. “Since 1988, our Cork operation has grown from the ground up into a Millipore Manufacturing Center of Excellence employing more than 580 people. We are very proud of our strong track record in process manufacturing.”
The new $83 million membrane casting facility is expected to produce a majority of the company’s membrane. These membranes are used in a range of Millipore products requiring filtration and purification. The company’s products are used to sterilize drug solutions, test beverages for purity, filter IV fluids in patient care and to support other applications in the medical device, pharmaceutical and biotechnology industries.
Posted on October 7, 2008 @ 09:16 am
Alnylam Pharmaceuticals has earned a $20 million technology transfer milestone from
Takeda Pharmaceutical Co. Ltd. as part of the companies' strategic alliance formed in May 2008. The payment is related to the transfer of Alnylam’s platform technology, including documents, materials, and intellectual property, to Takeda for the development of RNAi therapeutics. Alnylam also received a $100 million upfront payment when the deal was executed. Alnylam is eligible to receive an additional $30 million in technology transfer milestone payments.
“We are excited about the progress we have already made in enabling Takeda with Alnylam RNAi drug discovery capabilities and intellectual property,” said Barry Greene, president and chief operating officer at Alnylam. “We look forward to continuing our efforts in this strategic collaboration which is focused on advancing the development of RNAi therapeutics on a global basis, including Alnylam’s right to co-develop and co-commercialize certain Takeda RNAi therapeutic products in the U.S. market.”
The agreement provides Takeda with worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. It also includes a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi targets. Alnylam has opt-in rights to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S.
Posted on October 7, 2008 @ 09:15 am
Genentech and
Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.
An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.
"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."
Posted on October 7, 2008 @ 09:13 am
Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.
The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects from the California Institute for Quantitative Biosciences (QB3).
“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, Pacific Biopharma Group. “Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China.”
“We are delighted that PBG chose Pharmatech for this endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.
Posted on October 6, 2008 @ 08:48 am
Eli Lilly and Co. and
ImClone Systems have entered a definitive merger agreement under which Lilly will acquire ImClone for approximately $6.5 billion in cash. The acquisition of ImClone supports the Lilly's strategy to increase its focus on biopharmaceuticals and adds oncology therapies Gemzar, Alimta and Erbitux to its biologics pipeline.
The combined companies creates a biopharmaceutical oncology franchise offering targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target various solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic. The acquisition also expands Lilly's biotechnology capabilities with ImClone's development and commercial manufacturing facility, which will provide flexibility to develop and manufacture complex biomolecules.
"We think very highly of ImClone's ground-breaking work in oncology, particularly its success with Erbitux, a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "We are excited about the possibilities of improving outcomes for individual patients and building value for shareholders. This transaction will broaden our portfolio of marketed cancer therapies and boost Lilly's oncology pipeline with three promising targeted therapies in Phase III in 2009. By bringing together ImClone's and Lilly's marketed oncology products, pipelines, and biotech capabilities, we are taking a very important step forward in addressing the challenges of patent expirations we will face early in the next decade. We look forward to working with the ImClone team and their partners to ensure a smooth transition."
John H. Johnson, ImClone's chief executive officer, said, "We believe this is an important step forward in ImClone's and Lilly's shared goal of addressing the medical needs of cancer patients around the world. The significant progress ImClone has made over the last few years is a direct result of the important contributions of our employees, and joining forces at this stage of our growth will allow us to leverage Lilly's global capabilities and make even greater advancements in our proprietary pipeline."
Erbitux is marketed by ImClone's two partners, Merck KGaA and Bristol-Myers Squibb. ImClone co-promotes Erbitux in North America with BMS. In 2007, worldwide sales of Erbitux were approximately $1.3 billion.
Posted on October 6, 2008 @ 08:47 am
Perrigo Co. has acquired Laboratorios Diba, S.A. for approximately $25 million in cash. Based in Guadalajara, Mexico, Laboratorios Diba is a store brand manufacturer of OTC and prescription pharmaceuticals, including antibiotics, hormonals and opthalmics. The acquisition is expected to add nearly $15 million of annual sales.
Perrigo's chairman and chief executive officer, Joseph C. Papa stated, "Perrigo has been in the Mexican market for more than 65 years and is the leading supplier of prescription and OTC store brand products there. The acquisition of Laboratorios Diba will enable us to market an additional 150 formulas and 50 trademarks into the rapidly growing Mexican store brand market, saving consumers money on their healthcare options. This further exemplifies Perrigo's commitment to meeting the growing need for quality, affordable healthcare around the world."
Posted on October 6, 2008 @ 08:43 am
Alcan Global Pharmaceutical Packaging has acquired the Chakan flexible packaging plant from Associated Capsules Ltd. in India.
The acquisition expands Alcan's presence in the Indian pharmaceutical market. The Chakan facility has annual sales of $3.6 million and employs approximately 100 people. The integration into the Alcan Packaging group is expected to be completed in early 2009.
"The acquisition of this facility advances our leadership position in pharmaceutical flexibles through growth in emerging markets," said Ilene Gordon, president and chief executive officer, Alcan Packaging.
"Chakan is a well equipped plant with dynamic people and an asset base that will complement our current product portfolio," said Michael Schmitt, president of Alcan Global Pharmaceutical Packaging division. "The expertise with local pharmaceutical companies will be an excellent addition to our organization, increasing our ability to service global and regional customers while maintaining the high quality standards they have come to expect from us."
Posted on October 3, 2008 @ 09:23 am
Genentech, Roche, and
GlycArt (a company wholly-owned by Roche) have entered into a collaboration that includes a license from GlycArt to Genentech for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will develop GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
Under the agreement, the three companies will share certain development costs and Genentech will record $105 million in R&D expenses in 3Q08. Genentech will receive commercialization rights in the U.S. GA101 is currently in Phase I/II trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide Phase I data at the American Society of Hematology meeting in December 2008.
Pablo Umaña, chief scientific officer and co-founder of GlycArt, said, “With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
“This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
“Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, chief executive officer, Roche Pharmaceuticals. “The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”
Posted on October 3, 2008 @ 09:19 am
A federal court granted
Amgen a permanent injunction prohibiting
Roche Holding AG from selling its Mircera anemia treatment in the U.S., as well as upheld a jury verdict regarding certain patent-infringement claims.
Mircera is currently available in Europe and the FDA has approved the drug, but the legal dispute prevented its sale. The drug, if released in the U.S., would compete directly with Amgen's anemia drugs Aranesp and Epogen, which accounted for more than 40% of its revenue in 2007.
In March, a Massachusetts district county judge pushed back his decision on whether to grant Amgen the permanent injunction, asking a third party to compare dosing and pricing of the companies' products. A jury had found last October that Roche's Mircera infringes 11 of Amgen's patents protecting Epogen.
"Amgen is pleased with today's ruling, which recognizes that Amgen is entitled to a permanent injunction against Roche and reaffirms the infringement and validity of our patents," general counsel David Scott said in a statement.
Posted on October 3, 2008 @ 09:17 am
Alba Therapeutics Corp. has made several promotions.
Linda Arterburn, Ph.D., has been promoted to vice president of preclinical development and program management.
Francisco Leon, M.D., Ph.D., has been promoted to vice president, clinical development and medical affairs.
Roberto Allen has been promoted to vice president, legal affairs and intellectual property.
Mark Ginski, Ph.D., has been promoted to senior director of product and analytical development and
Kate Huber has been promoted to director of clinical operations.
Prior to joining the company, Dr. Arterburn was executive director of discovery research at Market Biosciences where she initiated an inflammation research program and was lead inventor on two patents involving novel anti-inflammatory lipids. Previously she led clinical research and scientific affairs at Market Biosciences. Dr. Arterburn also spent seven years at W.R. Grace & Co., where she led an in vitro toxicology research program, and then served as manager of technology and planning.
Dr. Leon is an immunologist with training in basic and clinical immunology and a clinical development in the field of mucosal immunology. Prior to joining the company, Dr. Leon was a director of clinical development, inflammatory and respiratory diseases at MedImmune, where he worked on asthma and mucosal vaccination. He was a director of clinical discovery, oncology / immunology at Bristol-Myers Squibb, where he worked on Crohn's disease, rheumatoid arthritis, and transplantation.
Prior to joining the company, Mr. Allen was president of Respire Medical, Inc., a respiratory and home health care provider serving the Mid-Atlantic region. He was also counsel at Kollman & Saucier, P.A., where he practiced general corporate and labor and employment law. Previously, he was a senior associate in the business department at Saul Ewing LLP.
Dr. Ginski's has experience with lead candidate selection, preformulation and formulation development, development, transfer and validation of analytical and bioanalytical methods, and packaging, labeling and distribution of clinical trial supplies. Prior to joining the company, Dr. Ginski served as associate director of preformulation sciences at Shire, where he played an integral role in developing and implementing Shire's Proscreen and Optiscreen programs designed to facilitate lead candidate selection and product development. Additionally, he worked at Guilford Pharmaceuticals, where he was responsible for leading exploratory pharmaceutics and CMC programs for various development programs. He has published numerous R&D articles and is an inventor for numerous global patents.
Ms. Huber has more than 25 years of experience in the health care industry and has been involved in all aspects of the conduct of Phase I - III clinical trials. She has worked in managing complex projects in the areas of celiac disease, oncology, CNS, vaccines, and diagnostics for HIV, HbsAg, and tuberculosis. Ms. Huber joins the company from Nabi Biopharmaceutical and Guilford Pharmaceuticals, where she had increasing responsibilities in the vaccine, oncology and CNS arenas. She has extensive experience in the diagnostic business and previously worked for Ortho Diagnostic Systems, Inc. and Pharmacia, where she helped develop diagnostic tools for pregnancy, HIV, Hepatitis B, and blood banking reagents.
Posted on October 2, 2008 @ 09:00 am
Merck has decided not to seek regulatory approval for taranabant, an investigational drug to treat obesity, and is discontinuing its Phase III development program for taranabant in obesity. The drug is similar to Acomplia, the Sanofi-Aventis obesity drug that was rejected by the FDA because of adverse events.
"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Labs. "We thank the patients and investigators around the world who collaborated with us on the research program for taranabant and look forward to developing new medicines for obesity to address the significant medical need posed by this disease."
Posted on October 2, 2008 @ 08:59 am
Christopher Perley has been named vice president and general manager of
Bristol-Myers Squibb's Devens biologics manufacturing facility. Mr. Perley will be responsible for continuing the supervision of the project to build the Devens facility and will have overall management responsibility for the site when it becomes operational in 2011.
“With an approved capital expenditure of $750 million, the Devens facility represents the largest capital investment in the history of Bristol-Myers Squibb,” said Carlo de Notaristefani, president of technical operations, BMS. “As the company evolves toward a next-generation biopharma model, combining the best of biotech with the best of a traditional pharmaceutical company, biologics will play an increasingly important role in driving our company’s future growth and success, and will be key in helping patients prevail over serious disease. Chris brings extensive biopharmaceutical experience that will support the company in this transition.”
Prior to joining the company, Mr. Perley was vice president of network strategy at Wyeth Biotech, where he gained experience in biopharmaceutical process development, production, supply chain management, and operations. Previously, he held manufacturing and biotechnology process development roles at the Genetics Institute in Andover, MA, and at Hoffmann-La Roche in Nutley, NJ.
Posted on October 2, 2008 @ 08:57 am
Biologic Safety Research, Inc. (BSR) is joining PreLabs, LLC to expand their contract laboratory operations. The existing BSR management team will integrate into the PreLabs organization and continue to guide the expanded group. PreLabs appointed Boris Predovich to serve as president and chief executive officer and Philippe Baneux, DVM to serve as chief scientific officer for the newly expanded company. PreLabs/BSR will provide discovery, preclinical and GLP testing.
“Market demand has created an exciting opportunity for us to expand our business,” said Robert Locke, BSR president. “Transitioning BSR into PreLabs will leverage our existing scientific and operational expertise while adding the CRO and pharmaceutical management expertise that Boris Predovich and Philippe Baneux bring with their 20 plus years at Covance and Pfizer, respectively.”
Posted on October 1, 2008 @ 09:01 am
GlaxoSmithKline plans to eliminate as many as 850 jobs in R&D in the U.S. and Britain, which represents 6% of the company's total R&D staff. According to a company statement, the cuts were necessary "to ensure that we can invest in key areas of future growth and evolve our business to compete effectively in what is a rapidly changing and challenging environment for pharmaceutical companies."
Earlier this year, the company had announced plans to cut 350 R&D positions. According to Claire Brough, a spokeswoman for the Brentford, U.K. office. The exact number of job cuts will be determined after consultations with employees and unions.
Andrew Witty, GSK's chief executive officer has pledged to increase the company's investment in outside research. According to Mr. Witty, half of GSK's drugs in development eventually could come from partnerships with outside firms. To support his plan, Mr. Witty has set up a board that includes venture capitalists to review R&D projects and decide which to fund. He has eliminated some areas of research in order to focus the company on eight disease areas. GSK has Centres of Excellence for Drug Discovery (CEDDs) dedicated to each disease area. These changes impact at least three CEDDs.
Posted on October 1, 2008 @ 09:00 am
Gergely Makara, Ph.D. has been named director of chemistry for European operations,
AMRI. Dr. Makara has responsibility for all European chemistry products and services including custom synthesis, medicinal chemistry, analytical services, library design and production. He will report to Philip Small, Ph.D., managing director of AMRI’s European operations.
Dr. Makara has more than 10 years of industrial experience focused on the development of compound libraries and lead optimization at leading drug discovery companies in the U.S. Most recently, he served as the head of Merck’s Target Validation Chemistry group where he was involved in setting up infrastructure for parallel chemistry synthesis and associated chemoinformatics. Prior to Merck, Dr. Makara was director, hit-to-lead optimization and chemical library development for Neogenesis Pharmaceuticals.
“Dr. Makara brings critical scientific and leadership experience to our European operations. His proven ability to form and lead innovative teams is particularly relevant in helping us to execute against our plan to expand services and operations offered to customers worldwide, and more specifically, to further relationships within the European marketplace,” said Dr. Small.
AMRI chairman, president and chief executive officer Thomas E. D'Ambra said, “The addition of Dr. Makara further demonstrates AMRI’s commitment to the restructuring plan initiated in May to provide a strong foundation for future expansion through realignment of customer offerings, with an emphasis on the expansion of medicinal chemistry and drug discovery services in Europe.”
Posted on October 1, 2008 @ 08:58 am
Tara Webb has been appointed senior director of business development,
Accelerated Community Oncology Research Network (ACORN). Ms. Webb will focus exclusively in the field of oncology, working closely with a select group of sponsors.
“Tara Webb has an exceptional background in the CRO field and is widely respected for her industry knowledge, capabilities and integrity,” said Edward J. Stepanski, Ph.D., chief operations officer of ACORN. “Her responsibilities at ACORN CRO will include presenting ACORN’s capabilities to pharmaceutical companies and emerging biotechs, forging alliances with key accounts and providing customer service oversight on behalf of clients.”
Ms. Webb brings a successful record of establishing and cultivating CRO relationships. Most recently, she served as senior director, business development for i3 Statprobe, where she was responsible for developing new business opportunities and strengthening current client relationships both nationally and internationally.
September 2008
Posted on September 30, 2008 @ 08:58 am
Pfizer will discontinue development of drugs for heart disease, obesity and bone health as part of its plan to focus research on Alzheimer's disease, diabetes, inflammation/immunology, oncology, pain and psychoses (schizophrenia), according to a company memo. The shift in R&D focus was led by president Martin Mackay, a Pfizer research executive who took over the division in October of last year.
"It's a continuous process to constantly evaluate our pipeline and make decisions based on high priority, unmet medical needs with market growth potential," said Pfizer spokesman, Ray Kerins. The plan is expected to include job and cost cuts, but will not affect products in late stage development or launches scheduled during the next three years, according to Mr. Kerins.
Sales of Pfizer's Lipitor, the world's top selling drug, are slowing as patients have access to generic forms of Merck's Zocor and Lipitor faces generic competition in 2011. Also, the company's second top seller Norvasc lost patent protection in 2007. In December 2006, the company discontinued development of cholesterol-lowering drug Torcetrapib after it was linked to deaths in a large trial, costing the company $800 million.
Posted on September 30, 2008 @ 08:56 am
MedImmune has licensed its reverse genetics technology to Biken, The Research Foundation for Microbial Diseases of Osaka University in Japan, for the development of new vaccine strains to produce non-live human influenza vaccines. Reverse genetics is a method that uses segments of DNA to generate viruses such as influenza. This method helps protect manufacturers from exposure to potentially highly infectious pandemic strains, such as H5N1.
MedImmune will receive an upfront payment and has the potential to receive royalties on certain vaccine stockpiles or sales of other flu products developed using the technology.
"MedImmune is pleased to license our reverse genetics technology to BIKEN as we have previously to four other influenza vaccine manufacturers," said Sun Park, MedImmune's vice president, corporate development. "Biken is the first Japanese influenza vaccine manufacturer to have entered into licensing agreements with MedImmune for access to the reverse genetics technology, and we are pleased that Biken's pre-pandemic vaccine using this technology is a key part of an ongoing Japanese government public health pilot program to vaccinate about 6,000 first responders and healthcare providers against a potential bird flu outbreak."
MedImmune applied the reverse genetics process to the development of its seasonal live, attenuated nasal spray flu vaccine for the 2008-2009 season.
Posted on September 30, 2008 @ 08:55 am
Enzon Pharmaceuticals, Inc. received approval from the Commission of the European Communities for designation of Oncaspar-IV, the next-gen pegylated L-asparaginase, as an orphan medicinal product.
Orphan drug designation creates favorable conditions for the development of drugs, including potential financial incentives, in addition to market exclusivity for as many as 10 years following approval.
“This announcement is a significant milestone in our overall plan to market the new Oncaspar-IV in new geographic territories.” said Jeffrey H. Buchalter, chairman and chief executive officer of Enzon. “We are currently developing the next-generation Oncaspar product to enhance the pharmaceutical properties of the approved version currently marketed in the U.S.”
Posted on September 30, 2008 @ 08:52 am
Analytical Bio-Chemistry Labs (ABC Labs) opened its new 90,000- sq.-ft. pharmaceutical development facility located at the University of Missouri’s Discovery Ridge Research Park, completing the transition of the company’s DMPK, bioanalytical and CGMP Analytical operations to the new facility. The facility more than doubles the company's previous capacity.
“The qualification of the new pharmaceutical facility is complete. All laboratory systems are validated, and scientific teams are quickly settling into their new home," said John Bucksath, senior vice president and general manager of ABC’s Pharmaceutical Division. “We are wrapping up a carefully choreographed project plan—and I’m delighted to report that the transition of pharmaceutical operations went very smoothly." In July, the FDA completed a pre-approval and General Quality Systems audit of the facility, which resulted in no 483s.
"This is an exciting time in ABC's history," says Byron E. Hill, president and chief executive officer. "This expansion provides the ideal platform for a new era of growth, productivity and exceptional client service."
The company will continue operating its chemical services and synthesis operations at its original campus located about five miles east of Columbia. The expansion at Discovery Ridge frees up space for these areas of the business as well. The company plans to renovate existing structures in 2009 to optimize operational efficiency.
Posted on September 29, 2008 @ 09:15 am
Cardinal Health plans to spin-off its clinical and medical products businesses as a separate public company that will be led by current vice chairman David L. Schlotterbeck. The spin-off is expected to be completed by mid-2009. This plan is an effort to enhance management focus and strategic vision, as well as better align management and employee incentives with performance and growth objectives, according to the company.
Chairman and chief executive officer, R. Kerry Clark, will continue to lead Cardinal Health through the spin-off and then will retire from the company. He will be succeeded by George S. Barrett, who has served as vice chairman and chief executive officer of Healthcare Supply Chain Services since joining the company in January. Mr. Barrett has more than 25 years of experience in the health care industry, most recently serving as president and chief executive officer of
North America
for Teva Pharmaceuticals.
"Since 1996, Cardinal Health has built an industry-leading med-tech business that, as an independent company, would have the size and scale to stand on its own," said Mr. Clark. "This business will be well positioned to deliver maximum value to customers and shareholders over the long term. We undertook a very disciplined exploratory process that involved our board, management and outside advisers. The result was a unanimous decision to move forward with the spin-off. This strategic decision will benefit Cardinal Health and the new med-tech company by allowing each business to focus on its unique growth strategies, capital needs and customer requirements, he continued.
In addition, Robert D. Walter will retire from the company’s board of directors when his term expires on November 5th. He will continue to serve as an adviser to the company. "I am fully supportive of our plans to spin off the clinical and medical products businesses and am confident that the two businesses will be well positioned as separate companies," Mr. Walter said. "With strong teams in place to lead these two organizations, my retirement from the board is the next logical step in my leadership transition at Cardinal Health."
Posted on September 29, 2008 @ 09:14 am
SAFC Pharma has commissioned a new suite at its
St. Louis
campus that will produce high-potency active pharmaceutical ingredient (HPAPI) conjugates to support oncology drug development. The 600-sq.-ft. suite will enable the conjugation of HPAPIs to a variety of targeted delivery molecules, including monoclonal antibodies. The new facility can also accommodate early-stage clinical supplies and can handle multi-kilogram quantities, with the capability to expand production up to commercial-scale.
"Bio-conjugates represent the next generation of 'smart munitions' in healthcare's anti-cancer arsenal," said Dave Feldker, SAFC Pharma vice president. "Due to our significant breadth of chemistry, containment engineering and biologics capabilities, SAFC Pharma is well-positioned as the leading player in this exciting niche.
"The HPAPI market has grown at a high double-digit pace; the number of customers we have has more than doubled over the past three years, with particular demand growth for biologic-HPAPI conjugates for oncology drugs," Mr. Feldker continued. "Dozens of products are currently in clinical trials, and this new facility underline's SAFC's intent to support growth in this niche, strengthening our position as the leading pipeline partner for the pharmaceutical and biopharmaceutical industry."
During the past year, the company has announced investments totaling $75 million to expand HPAPI capacity, including a $4.5 million project to add a cGMP pilot plant and kilo-lab capacity at Madison, WI, completed earlier this year; a $29 million investment to expand bacterial and fungal fermentation-derived HPAPI capacity in Jerusalem, due for completion in 2009; and a $30 million investment to build a commercial-scale HPAPI facility at Madison, due to be completed by year-end 2009.
Posted on September 29, 2008 @ 09:13 am
SAFC Pharma’s new reactor at its
Arklow,
manufacturing site has begun operation, expanding the facility's capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%.
The $4 million project involved the installation and start-up of a 6,000 liter Hastalloy reactor for large-scale API manufacturing, increasing the total capacity at the site to 96,000 liters, with a reactor range from 250 to 8,000 liters. This adds capacity for both large- and small-scale manufacturing.
SAFC Pharma vice president
Europe
, Dr. Michael Harris, commented, "Our continued investment in capabilities and capacity is a direct reflection of SAFC's long-term commitment to meeting customer requirements for API manufacturing. Our continuing investments in facilities and personnel support the growth of SAFC Pharma and underline our position as an industry leader whose focus includes the responsibility to reduce our environmental footprint."
The 64,000-cubic-meter Arklow complex is cGMP, FDA and IMB inspected and validated. It supports new process evaluation, process development validation and technology transfer. The site's process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and large-scale simulated moving bed (SMB) chromatography for chiral separations.
Other expansion projects at the Arklow site include the building of a $2.25-million, 15 kg capacity pilot-scale filter dryer designed to double the facility's current capacity for small-scale (10 kg-150 kg) manufacturing of APIs, and a $1.8-million expansion of the site's cGMP warehouse capacity.
Posted on September 29, 2008 @ 09:12 am
Jon Brewer has been named vice president, sales and marketing, BASi. He replaces Emilio Córdova who has resigned to pursue other opportunities. Mr. Brewer has nearly 25 years of experience as a sales and marketing executive in the pharmaceutical industry. Most recently he consulted with companies to develop and implement new business strategies. Previously he served as vice president of Integrity Pharmaceuticals and continued in this role through the merger with Xanodyne, a specialty pharmaceutical company based in
Cincinnati, OH
. He has a background of developing and executing product launches and sales strategies.
Posted on September 25, 2008 @ 05:01 am
Ligand Pharmaceuticals has entered into a merger agreement to acquire
Pharmacopeia, in an all-stock deal valued at $70 million. In addition to the share value, Pharmacopeia stockholders will be entitled to a Contingent Value Right (“CVR”) that entitles a cash payment of $15 million for all Pharmacopeia stockholders, under certain circumstances.
“We are very excited about combining Pharmacopeia with Ligand,” said John L. Higgins, president and chief executive officer of Ligand. “Ligand stockholders will gain access to numerous royalty partnerships, additional pipeline assets, drug discovery resources and cash and NOLs. Pharmacopeia’s shareholders will receive a substantial amount of equity in a well capitalized company with lucrative potential royalties, an expanded pipeline and financial liquidity."
He added, "This is a unique opportunity for Ligand and Pharmacopeia shareholders. Both companies have similar growth strategies, and our respective drug discovery platforms are a great marriage of biology and chemistry resources. The acquisition of Pharmacopeia will complement and accelerate our product development programs, strengthen our research capability and increase our potential royalty streams.”
Joseph A. Mollica, Ph.D., chairman, interim president and chief executive officer of Pharmacopeia, stated, “Pharmacopeia’s portfolio of programs is an excellent complement to Ligand’s pipeline and over the next decade we believe the combined company will have important product introductions. On behalf of our Board, I would like to thank all of our employees for the dedication they have shown in pursuit of our scientific goals and the value they have created for our shareholders. We are excited about this transaction and look forward to sharing in the potential upside of the combined businesses by joining forces with a strong company like Ligand.”
Under the terms of the agreement, Ligand shareholders will own 84% of the combined company and Pharmacopeia stockholders would own approximately 16%. The transaction is expected to close by 1Q09.
Posted on September 25, 2008 @ 04:54 am
Lonza and
Crucell have entered into a co-exclusive manufacturing, sales and distribution agreement related to the Permexcis cell culture medium developed by Crucell for PER.C6 cells. Under this agreement, Lonza will manufacture the medium, and in addition will market and sell it on a global basis. Financial details of the agreement were not disclosed.
The Permexcis medium is a chemically defined cell culture medium that does not contain human- or animal-derived components. Permexcis medium was developed for the cultivation of PER.C6 cells and has been designed for use in the large-scale manufacture of biopharmaceutical products, including vaccines, according to a Crucell statement.
"We are pleased to have entered into this agreement with Lonza. The agreement demonstrates the power and robustness of our PER.C6 technology. Over 60 companies and organizations have already selected our PER.C6 technology to develop their own products across a wide range of therapeutic areas. We are proud that Lonza will manufacture the Permexcis cell culture medium and in addition will market and sell it globally" said Ronald Brus, Crucell's chief executive officer.
Posted on September 25, 2008 @ 04:50 am
Merck and
Japan Tobacco Inc. (JT) have signed a worldwide licensing agreement to develop and commercialize JTT-305, an investigational oral osteoanabolic (bone growth stimulating) agent for the treatment of osteoporosis.
Merck will gain worldwide rights, except for Japan, to develop and commercialize JTT-305. JT will receive an upfront payment and is eligible to receive additional cash payments upon achievement of certain development milestones associated and product royalties.
JTT-305 is an oral calcium sensing receptor (CaSR) antagonist that is currently being evaluated by JT in Phase II clinical trials in Japan for its effect on increasing bone density; it is in Phase I clinical trials outside of Japan.
“Through this agreement with Merck, JT is well positioned to maximize the therapeutic potential for JTT-305 as a possible future option for patients with osteoporosis,” said Noriaki Okubo, president of JT’s pharmaceutical business.
"Partnering with JT to develop this novel compound complements Merck's portfolio of musculoskeletal drug candidates," said Alan B. Ezekowitz, MBChB, D.Phil., senior vice president and franchise head, Bone, Respiratory, Immunology, and Endocrine, Merck Research Laboratories. "In the future, we believe that use of antiresorptive and osteoanabolic agents together may provide an effective way to reduce the risk of fractures in patients with osteoporosis."
Posted on September 24, 2008 @ 07:36 am
Dyax Corp. has completed its BLA for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review; if granted, this would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority designation is intended for those products that address unmet medical needs. DX-88 was previously granted Orphan Drug designation and Fast Track status by the FDA.
The final portion of the BLA, the clinical section, was based primarily on data from two Phase III clinical studies, EDEMA3 and EDEMA4, which together represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE, according to a Dyax statement. In these studies, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints.
“The submission of the DX-88 BLA is a major milestone for Dyax,” commented Henry E. Blair, chairman, president and chief executive officer of Dyax. “We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working with the FDA to make this important product candidate available to HAE patients as soon as possible.”
The recombinant, small protein, DX-88, was discovered utilizing the company’s proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema.
Posted on September 24, 2008 @ 07:34 am
Takeda's U.S. subsidiary, Takeda Global Research & Development Center, Inc., has submitted an NDA for alogliptin and Actos in a single tablet for the treatment of type 2 diabetes.
Alogliptin is a DPP-4 inhibitor; that class slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. ACTOS is a thiazolidinedione (TZD) drug that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. Takeda is the originator of the TZD class of oral anti-diabetes medications.
"Alogliptin/ACTOS, if approved, will be the first type 2 diabetes treatment option which includes a DPP-4 inhibitor and a TZD," said Yasuchika Hasegawa, president of Takeda. "Given the increased global incidence of type 2 diabetes and the need for new treatment options, we will strive to provide alogliptin/ACTOS, as a potentially important treatment option, to patients and healthcare providers."
The NDA submission was supported by two phase 3 clinical trials, involving more than 2,000 patients worldwide. The studies assessed the efficacy and safety of this therapy for the treatment of patients with type 2 diabetes not achieving glycemic targets with diet and exercise alone, or for patients uncontrolled on metformin. Study results showed that alogliptin/ACTOS produced significant improvements in glycemic control and measures of insulin resistance and beta-cell function.
Posted on September 24, 2008 @ 07:30 am
inVentiv Clinical Solutions, LLC, a division of
inVentiv Health, has continued its expansion outside North America with a new office in Madrid. The company plans to expand operations to other European countries, including Eastern Europe.
inVentiv Clinical's European operations will be led by Fernando Martinez, Ph.D., MBA, recently appointed as director, Clinical Operations, Europe. Dr. Martinez is responsible for building the unit's European presence and client base. He is also responsible for oversight of all of its European projects.
"We are excited to take this next step along the path to globalization, adding this new European location to our already established operations in India and Latin America," said Mike Hlinak, president and chief executive officer of inVentiv Clinical. "Dr. Martinez has the expertise and skill to help us build our presence in Europe to continue to provide superior quality services to our clients."
Posted on September 23, 2008 @ 09:00 am
Parexel has expanded its early phase drug development capabilities with a dedicated unit to provide biopharmaceutical companies with support for proof-of-concept studies. The new unit integrates capabilities in regulatory strategies, drug development, and clinical pharmacology. Proof-of-concept studies are mainly used in targeted patient populations and are designed to demonstrate early signals of a product's efficacy. The goal of these studies is to help avoid costly late stage clinical development failures.
"As the biopharmaceutical industry explores new development paradigms to bring safe and effective treatments to market more efficiently, companies are conducting a growing number of complex and rigorous proof-of-concept studies. Providing clients with integrated, early phase development strategies and expertise gives them the ability to support early identification and selection of the most promising compounds," said Herman Scholtz, M.D., corporate vice president, Early Drug Development, Parexel.
A dedicated team will provide clients with the required scientific, therapeutic, and regulatory services to design and implement these studies for new drug entities across a range of therapeutic indications. This team offers solutions including the use of biomarkers and adaptive trial designs, which are supported by biostatistical and eClinical technology capabilities. Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory, as well as EDC to provide rapid access to study data.
The proof-of-concept service offering provides the company's SuperSites capabilities together with a global network of investigator and academic sites to help accelerate patient recruitment. The SuperSites solutions use the company's hospital-based Clinical Pharmacology Research Units, drawing on recruitment specialists and relationships with local, hospital-based physicians as well as on-site call centers and database capabilities.
Posted on September 23, 2008 @ 08:59 am
Tris Pharma has completed the expansion of its research and manufacturing facility in South Brunswick, NJ. The expansion provides 15,000 sq. ft. of additional space to the facility and is FDA-compliant with cGMP. It allows for additional commercial-scale equipment and a new, larger warehouse with a high-speed packaging area.
"These recent events show that the company is on a steady and stable path as charted," says Ketan Mehta, chief executive officer and founder of Tris Pharma. "FDA's assurance of our facilities and the recent investment in our capabilities mean we have ample infrastructure with which to leverage our pipeline of drug delivery technologies and services."
Posted on September 23, 2008 @ 08:56 am
Ronald Shoup has been named executive director of Pharma Services,
AIT Laboratories. Mr. Shoup was the former co-founder and chief scientific officer of West Lafayette, IN-based Bioanalytical Systems, Inc. (BASi).
"Ron brings 30 years of leadership, entrepreneurship, and scientific expertise to AIT as we look to expand our facility to meet the growing needs of the Pharma industry," said AIT president and chief executive officer, Michael A. Evans, Ph.D.
AIT supports clinical trials through its current drug analysis services and plans to offer regulated bioanalytical services for preclinical development in the future. AIT develops, validates, and performs mass spectrometry analysis in support of new drug development.
Posted on September 22, 2008 @ 09:51 am
Schering-Plough plans to cut 20% of its U.S. sales force by October 1 as part of a previously announced restructuring plan aimed at saving $1.5 billion by late 2012. The company said it will eliminate 1,000 sales positions from its U.S. Primary Care field force, which markets prescription drugs to physicians, and make organizational changes within the operation. According to the company, 4,000 positions will remain.
The restructuring program, announced in April, was designed in part to eliminate costs associated with the company's $14.5 billion acquisition of Organon BioSciences.
Posted on September 22, 2008 @ 09:50 am
Genzyme Corp. opened its new Science Center in Framingham, MA. The facility serves as a central site for early stage research to discover new treatments for diseases such as Parkinson's, cancer, and heart disease. The Science Center has received a Gold certification under the U.S. Green Building Council's LEED (Leadership in Energy and Environmental Design) Green Building Rating System. It's one of 10 labs to receive this rating.
"Genzyme exists to innovate, and the Science Center reflects this purpose," stated Henri A. Termeer, Genzyme's chairman and chief executive officer. "The work done at this facility will ensure that we can continue to bring forward therapies to significantly improve patients' lives and will help support the company's long-term growth. I am so proud of our scientists who discover and make possible life-saving medicines."
Researchers at the Science Center focus on areas including genetic diseases, cancer, immune diseases, kidney disease, cardiovascular disease, endocrinology and neurological disorders, and utilize a range of technologies, such as proteins, antibodies, cell therapy and gene therapy.
Posted on September 22, 2008 @ 09:49 am
John J. Dupree has joined
Girindus as senior director, business development. Mr. Dupree has more than 34 years of sales, business management, and corporate accounts management experience. He spent his entire career with Eastman Chemical Co. as a senior corporate account executive until joining Girindus.
“John Dupree is a known leader in the custom chemistry market and has had an impressive career with Eastman Chemical. He brings with him significant knowledge and experience in numerous areas of the chemical business. We look forward to the expertise and passion John brings to Girindus,” commented Mark Laskovics, president and chief operating officer of Girindus America, Inc. “I am excited to join the impressive Girindus Team and working with Girindus’ customers, developing the growing Oligonucleotide medicines market,” said Mr. Dupree.
Posted on September 19, 2008 @ 09:31 am
Laureate Pharma, Inc. is increasing its manufacturing capacity with the addition of two Single-Use Bioreactors (S.U.B.), a 250L and a 1000L S.U.B. The S.U.B. is a single-use alternative to stirred tank bioreactors. The S.U.B. consists of a permanent stainless steel outer support container and a Bioprocess Container (BPC), integrated with an existing bioreactor control system. According to the company, this provides a flexible, rapid and economic option to update or increase the bioreactor capacity. The S.U.B. will supplement the company’s current single-use bioreactors, Wave Bioreactors and hollow-fiber systems, as well as the conventional stainless steel stirred-tank bioreactors.
“We are excited about adding the S.U.B. to increase our bioreactor capacity. It is a scalable technology that will support the demand from our growing client base and meet their needs and manufacturing objectives,” said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. “The HyClone S.U.B. provides us with all the advantages of single-use bioprocessing, while maintaining aspect ratios and agitation mechanisms comparable to traditional stainless steel stirred-tank bioreactors.”
Posted on September 19, 2008 @ 09:29 am
MethylGene, Inc. has exercised its right to convert to a royalty and milestone arrangement with
Celgene Corp. for MGCD0103 under the 2006 license and collaboration agreement between the companies.
MethylGene will no longer be responsible for development costs for the drug. Celgene will assume all program costs for its licensed territories. MethylGene will receive royalties in lieu of profit sharing in North America and is eligible to receive milestone payments of as much as $141 million. Celgene will also pay royalties to MethylGene on annual sales in its territories. MethylGene retains its rights under the original terms of the agreement to co-develop and co-promote subsequent compounds, including second-generation histone deacetylase (HDAC) inhibitors and sirtuin inhibitors for cancer.
"We believe that MGCD0103 presents a promising opportunity for the treatment of cancer. After thoughtful and careful analysis conducted with outside consultants, we have concluded that converting to a royalty at this time is financially advantageous," said Donald F. Corcoran, president and chief executive officer of MethylGene. "Moving forward, while participating in the upside and potential of MGCD0103, we will be focusing on developing the two compounds of which we own 100%, MGCD290 and MGCD265, which are expected to enter Phase I trials by the end of this year."
Posted on September 19, 2008 @ 09:28 am
A new study of
Novartis' MF59-adjuvanted vaccine showed that it rapidly induced protective antibody levels against diverse strains of avian flu. In the study, individuals immunized six years earlier with an MF59 adjuvanted H5N3 (clade 0) vaccine mounted a protective immune response seven days after a single immunization with an H5N1 (clade 1) vaccine containing Novartis' adjuvant MF59. The immune response was broadly cross reactive and covered all H5N1 clades known to date.
In addition, these study results suggest individuals primed with an MF59-adjuvanted H5 vaccine, would only need one dose of an MF59-adjuvanted vaccine in a pandemic situation to elicit initial protection reducing overall response time, and potentially the spread of the virus.
Posted on September 18, 2008 @ 09:15 am
Bilcare Global Clinical Supplies has completed the expansion of its warehouse and distribution facility in Phoenixville, PA. The facility now provides 300% more ambient storage capacity, as well as a 50% larger distribution pack-out area, and a second distribution dock for increased output.
"The increase in storage capacity is the latest in a series of global upgrades designed to demonstrate to customers that Bilcare is a company focused on providing high quality service and cutting edge technology for its customers to ensure on time project completion," said Bilcare GCS, Americas president Vincent Santa Maria.
In addition to this facility expansion, the company has expanded its facility in Rajgurunagar, near Pune, India and plans a $21 million expansion for a new clinical supplies facility in South Wales.
Bilcare GCS chief executive officer, Vito Mangiardi stated, "These capital improvements combined with our experienced project managers and global footprint in the Americas, Europe and Asia signifies that Bilcare GCS is a growing company committed to providing world-class service."
Posted on September 18, 2008 @ 09:14 am
Crucell has signed an exclusive, commercial license agreement with NC-based
Talecris Biotherapeutics for an undisclosed protein to be produced using the PER.C6 cell line. Crucell will receive an upfront payment of $2.5 million and will be eligible for milestone payments of approximately $30 million across multiple indications. Further details were not disclosed.
Posted on September 18, 2008 @ 09:11 am
Roger Rush, Ph.D. has been named vice president of preclinical development,
Wolfe Laboratories. Dr. Rush has more than 25 years of international experience in pharmaceutical R&D with a focus on preclinical research, development, and program management, particularly in the transition of discovery research candidates to clinical development.
"We're delighted to have Dr. Rush as part of our team," said Janet Wolfe, Ph.D, president of WLI. “His wealth of experience will be a tremendous asset to the company. He will play a critical role in the company as we expand our services and continue to provide clients with the highest quality preclinical services in a timely manner."
Prior to joining the company, Dr. Rush held a number of positions of increasing responsibility with pharmaceutical and biotechnology companies, including department head of drug metabolism at Syntex Research in Europe, and vice president of preclinical sciences at Roche Pharmaceuticals, which involved responsibility for the functions of drug metabolism and pharmacokinetics, toxicology and pathology, and pharmaceutical development. Throughout his career he has contributed to the approval of numerous INDs, CTAs, NDAs and MAA drug registration dossiers.
Dr. Rush participated in the transition of the Syntex Research Centre in Edinburgh into Quintiles Transnational and established that facility as a provider of pharmaceutical R&D services. In his role as business development director he was responsible for the sales and marketing of Quintiles’ preclinical services.
Posted on September 17, 2008 @ 09:20 am
Valeant Pharmaceuticals has signed a definitive agreement to acquire
Coria Laboratories, Ltd., a specialty pharmaceutical company focused on dermatology products in the U.S., for $95 million. This acquisition expands Valeant’s U.S. business and adds to its dermatology franchise with the acquisition of several products, for which annual sales are approximately $40 million. Coria was owned by DFB Laboratories, which also owns DPT Laboratories, a contract development and manufacturing organization (CDMO).
“Valeant is committed to growing our dermatology franchise and this acquisition is a key step in transforming this business in the U.S. and gaining the critical mass and profitability we need,” said J. Michael Pearson, chairman and chief executive officer of Valeant. “The acquisition of Coria provides Valeant with access to a unique product portfolio, which includes both prescription and OTC products, additional pipeline opportunities for the future and a talented dermatology workforce. With the identified synergies between the two companies, we expect this transaction will be accretive to our earnings in 2009.”
The Coria transaction will add the following marketed dermatology products: CeraVe Skin Care Line, Cloderm Cream for the treatment of dermatoses, Akne-Mycin and Atralin for the treatment of acne, and Salex for the treatment of hyperkeratotic skin disorders, as well as Tetrix Cream for the treatment of hand dermatitis, which is expected to launch later this year. Coria also has several products under development, including line extensions for the CeraVe brand product line.
Posted on September 17, 2008 @ 09:17 am
Pharmatek has opened its highly-potent and cytotoxic facility in San Diego, CA. The 18,000-sq.-ft. facility includes newly constructed analytical and formulation development labs and cGMP manufacturing suites for the development of highly-potent and cytotoxic drug product for early phase clinical trials.
The facility holds a State of California Food and Drug Branch (FDB) Drug Manufacturers License and is currently working on several highly-potent development projects. The FDB license authorizes Pharmatek to manufacture and ship clinical material from its manufacturing and development site.
"Highly-potent and cytotoxic compounds are among the most sensitive drugs to handle and produce," said Kevin Rosenthal, director of manufacturing of Pharmatek. "Our primary goal when designing the facility was to optimize product quality while ensuring operator safety to guarantee our clients' drug candidates move smoothly from discovery to clinical trials."
Posted on September 17, 2008 @ 09:15 am
Millennium (a.k.a. The Takeda Oncology Co.) has added
Claire Thom, Pharm.D. as senior vice president, portfolio management and
Isabelle Mercier as vice president, marketing for Millennium's commercial organization.
"We are very excited to have these two, highly-successful pharmaceutical executives join the Millennium team to help lead the organization towards becoming a top three global oncology company," said Deborah Dunsire, M.D., president and chief executive officer, Millennium. "Claire and Isabelle will offer insight and perspective to effectively develop and market the molecules in our expanding oncology pipeline as well as bring a proven level of entrepreneurship and innovative thinking."
Dr. Thom joins Millennium with nearly 20 years of experience in drug development, new product planning and marketing. She will be responsible for the oncology portfolio management process. Previously, Ms. Thom was responsible for the oversight and implementation of the global therapeutic area strategies for oncology, urology and gynecology franchises of Takeda Pharmaceutical Co. in Japan. She also held several senior R&D and product planning positions at Takeda Global R&D and Takeda Pharmaceuticals North America. Prior to Takeda, she held positions of increasing responsibility at G.D. Searle and Co. in the areas of global new product planning and U.S. oncology marketing.
Ms. Mercier brings more than 16 years of global pharmaceutical marketing experience. She will lead and develop U.S. and global marketing strategy for the commercialization of late phase development products as well as marketed oncology products, including Velcade for Injection for patients with multiple myeloma. She joins the company from Sanofi-Aventis and most recently served as vice president of Taxotere Marketing. She also has global experience in sales, clinical research and oncology product launches from Sanofi-Synthelab and SangStat Medical Corp.
Posted on September 16, 2008 @ 09:00 am
GlaxoSmithKline and
XenoPort, Inc. have submitted a NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the U.S. and can result in symptoms that disrupt sleep and impact daily activities.
The NDA submission is based on a Phase III clinical development program for Solzira in RLS patients, including data from two randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of Solzira over 12 weeks. The submission also included results from a third trial evaluating the ability of the drug to maintain efficacy in treating RLS symptoms over a nine-month period. The most common side effects of Solzira were dizziness and somnolence.
"GSK is committed to bringing innovative products to patients where there is unmet medical need," said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicine Development Center. "We believe that Solzira may offer a new therapeutic option to treat primary Restless Legs Syndrome, a condition that includes both sensory and motor symptoms."
"We are very encouraged by the results that we have seen in the clinical development program for Solzira," said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. "Solzira is the first non-dopaminergic compound to demonstrate efficacy in large, controlled clinical trials for the treatment of primary RLS, and we believe it will offer patients a beneficial alternative to currently approved therapies."
Posted on September 16, 2008 @ 08:59 am
Charles River Labs has acquired
Molecular Imaging Research, Inc. (MIR Preclinical Services) for approximately $12.5 million in cash. MIR, based in Ann Arbor, MI, provides discovery services using extensive in vivo imaging capabilities to pharmaceutical and biotechnology clients.
MIR offers non-GLP preclinical efficacy testing services with expertise in the therapeutic areas of oncology and inflammation, employing a variety of in vivo imaging techniques. MIR applies a wide array of high-throughput and efficient imaging technologies, including preclinical positron emission tomography (PET), preclinical micro-computed tomography (CT), anatomical and functional magnetic resonance imaging (MRI), and bioluminescence and fluorescence biophotonic imaging. These imaging services allow for noninvasive and quantitative analysis of both efficacy and mechanism of action, with the goal of accelerating the drug discovery process. The company also offers other in vivo, in vitro and analytical services. MIR will join Charles River Discovery Services to evaluate the efficacy of compounds.
James C. Foster, Chairman, president and chief executive officer of Charles River, said, "As pharmaceutical and biotechnology companies increasingly seek the means to accelerate their drug development efforts, in vivo imaging is becoming a key tool in making more effective and informed 'go/no-go' decisions early in the drug development process. The addition of MIR’s oncology and inflammation therapeutic expertise and state-of-the-art in vivo imaging capabilities allows Charles River Discovery Services to offer a broader portfolio of efficacy testing services to better support our clients’ needs. We welcome MIR Preclinical Services to the Charles River family."
Dr. W.R. “Dick” Leopold, president and chief executive officer of MIR, commented, “At MIR, we have dedicated ourselves to improving the drug development process by building a leading preclinical imaging business with drug discovery expertise in key therapeutic areas. By joining with Charles River, we will be able to extend our joint reach and aide our clients in finding treatments for cancer and other devastating diseases.”
Posted on September 16, 2008 @ 08:57 am
Perrigo Co. has acquired
JB Laboratories for approximately $44 million in cash. JB Labs is a contract manufacturer of OTC and nutrition products for healthcare suppliers in the U.S. The acquisition is expected to add more than $70 million in annual sales.
Perrigo's chairman and chief executive officer, Joseph C. Papa, stated, "The acquisition of JB Laboratories will further expand our high-quality manufacturing base and provide additional FDA-approved production capacity to help us service our current and future customer needs. And in addition to the immediate top line sales contribution, this investment will be accretive to earnings this year and beyond. This acquisition further exemplifies Perrigo's commitment to meeting the world's growing need for quality, affordable healthcare."
Posted on September 15, 2008 @ 09:45 am
Talecris Biotherapeutics, Inc. received approval from the FDA for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue and can cause severe impairment of motor skills. Gamunex is the first therapy approved for the treatment of CIDP as well as the first IVIG therapy approved in the U.S. to treat a neurological disorder.
The FDA’s ruling provides Orphan Drug Designation for Gamunex, which grants Talecris marketing exclusivity for the treatment of CIDP for seven years. This approval was based on results from the first and only large-scale trial for the treatment of CIDP. The study validates the long-term safety and efficacy of Gamunex as the first line and maintenance treatment for CIDP, according to a Talecris statement.
“We are proud to be the first company to prove the efficacy of an IGIV product for CIDP,” said Lawrence Stern, president and chief executive officer for Talecris Biotherapeutics. “For people with this neurological disorder, Gamunex provides a safe and effective method of treatment. To help provide patients access to this important therapy, we are working to substantially increase supplies of Gamunex in 2009.”
Posted on September 15, 2008 @ 09:45 am
Pfizer updated safety and efficacy results for its investigational compound CP-751,871 in patients with non-small cell lung cancer (NSCLC). Results from a Phase II, randomized, non-comparative study showed 54% of patients with Stage III/IV treatment-naïve NSCLC receiving the combination CP-751,871 plus carboplatin and paclitaxel experienced objective responses. The response rate was 41% in patients treated with carboplatin and paclitaxel alone.
Also, 78% of a subset of patients with squamous cell carcinoma and 57% of a subset of patients with adenocarcinoma receiving 20 mg/kg of CP-751,871 plus carboplatin and paclitaxel experienced objective responses. Response rates were 46% and 25%, respectively, for squamous cell and adenocarcinoma patients receiving carboplatin and paclitaxel alone. No response advantage with CP-751,871 was seen in a subset of patients with undifferentiated tumors.
Patients receiving CP-751,871 20 mg/kg showed the greatest improvement in progression-free survival (PFS). PFS was defined as either the length of time before the cancer progressed or death. Of the 53 patients in the carboplatin and paclitaxel arm, 20 crossed over to receive CP-751,871.
The side effects of CP-751,871 were generally manageable. The most common side effects reported in this study were fatigue (10%), hyperglycemia (20%) and neutropenia (30%).
Posted on September 15, 2008 @ 09:43 am
ProStrakan Group received approval from the FDA for Sancuso (Granisetron Transdermal System), the first patch to provide five days of control of nausea and vomiting for patients undergoing chemotherapy.
Chemotherapy-induced nausea and vomiting (CINV) is common among patients undergoing chemotherapy and can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment.
Sancuso is a transdermal patch that delivers granisetron through a thin layer of adhesive that attaches to the skin. The medicine is then released slowly and continuously into the bloodstream for as many as five consecutive days.
The approval is based on the results from a multicenter Phase III randomized, double-blind, study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron. The trial enrolled 641 patients undergoing chemotherapy, and met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron. Complete control was defined as no vomiting and/or retching, no more than mild nausea and no rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy. Sancuso was generally well-tolerated.
Posted on September 12, 2008 @ 09:17 am
MedImmune, the global biologics unit of AstraZeneca, and
SBI Biotech Co., Ltd, have entered into a licensing and collaboration agreement to develop and commercialize SBI Biotech's anti-ILT7 protein for the potential treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases. MedImmune will have global rights to any resulting product candidates and will be responsible for preclinical and clinical development, as well as all future development, manufacturing, sales and marketing activities.
Under the terms of the agreement, SBI Biotech will receive an undisclosed upfront payment, milestone payments and royalties on future marketed products. MedImmune has an exclusive license to research, develop and commercialize products that target the ILT7 protein. MedImmune will also have the option to license additional targets resulting from SBI Biotech's research activities.
"It's an honor to work with Ken-ichi Arai, founder of SBI Biotech and one of Japan's leading scientists. We look forward to collaborating with him and his organization as we develop potential new treatments for autoimmune diseases such as SLE," said Anthony J. Coyle, Ph.D., vice president, research, respiratory, inflammation and autoimmunity. "As an innovative company dedicated to making a difference for patients, MedImmune will continue to seek out research and development initiatives that may address some of society's critical unmet medical needs."
Posted on September 12, 2008 @ 09:16 am
GlaxoSmithKline has formed GSK Oncology, a newly integrated Oncology R&D Organization. GSK Oncology unites small discovery units (DPUs) within the existing Centre of Excellence for Drug Discovery (CEDD), and a highly specialized drug development group to create a dedicated oncology R&D organization, led by Paolo Paoletti, M.D., senior vice president Oncology R&D.
“GSK has designed this new organization to help us increase the breadth and depth of our core oncology knowledge, in order to ultimately deliver more innovative medicines that enhance cancer patients’ lives,” said Dr. Paoletti. “By creating an end-to-end R&D unit we are able to capture the many synergies that exist between discovery and development in oncology. The application of translational medicine will bring about significant enhancements to the R&D group via the ‘bench to bed’ connection — the constant loop and flow of information from early to late stage development, and vice-versa.”
“The newly formed GSK R&D Oncology Unit is directly aligned with our R&D strategy to deliver more products of value, and will help us increase our efforts towards personalized medicine in oncology,” said Moncef Slaoui, chairman, R&D. “This dedicated unit will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit’s large portfolio of medicines.”
Posted on September 12, 2008 @ 09:14 am
TestPak has launched its latest child-resistant and senior-friendly compliance packaging system,
Stora Enso’s Pharma DDS. Pharma DDS is a flexible and reclosable system with the capacity to contain a 30 count supply of most solid dose products and can be tailored to fit various blister designs. Its opening lock feature is designed to require minimal dexterity and provide ease of use. DDS has been tested successfully in the U.S. and in Europe for child-resistance and senior-friendliness, meeting F=1 child-resistant performance.
“We are very pleased to introduce DDS to our line-up because it adds another outstanding compliance packaging option for our customers. We have high expectations for DDS because of its ease of use and cost-effectiveness,” said Bill Eveleth, vice president sales and marketing at TestPak. Based on initial customer inquiries, the company already has a number of design applications on the drawing board.
“Stora Enso appreciates the dedication of TestPak towards the pharmaceutical compliance packaging market. The adoption of Pharma DDS further strengthens our cooperation with TestPak and provides a great avenue to the market,” stated Ralph Mendoza, sales manager of Stora Enso Pharmaceutical Solutions.
Posted on September 11, 2008 @ 09:31 am
Norwich Pharmaceuticals, Inc., a provider of contract manufacturing and packaging services, will implement
SupplyScape Corp.’s Nexus solution to drive visibility, control and efficiency within its business operations and among its trading partners. Norwich will utilize Nexus to offer its client base a full suite of serialization services to monitor and optimize product movement, security and supply chain performance, according to a company statement.
SupplyScape Nexus is a business collaboration environment designed to help companies and their partners connect and share rich product information across business processes. By combining serialization and electronic pedigree information with operational and transaction data, organizations can dramatically improve supply chain visibility and business responsiveness to changing supply chain conditions, said SupplyScape.
As one of the first outsourcing providers to implement the Nexus solution, Norwich Pharmaceuticals president, Chris Calhoun, contends the initiative is part of the company’s mission. “Norwich is committed to providing our customers with uncommon value and everyday excellence – and SupplyScape helps us achieve that,” he remarked, adding, “In addition to innovative technology, deep domain expertise and strong partnerships with technology leaders such as SAP, SupplyScape’s value chain network-based approach enables us to offer our customers a comprehensive set of serialization packaging and patient safety services to meet all their customers’ needs.”
Posted on September 11, 2008 @ 09:30 am
Quintiles Transnational Corp. will expand its Singapore operations to meet the growing demand in the Asia-Pacific region. The new regional headquarters will be double the size of its existing presence in Singapore. The company has also expanded seven local offices in the region and the added a new location in Indonesia.
"Our growth in Singapore has been bolstered by the expanding base of companies and research institutes in Singapore's larger biomedical sciences research community," said Anand Tharmaratnam, M.D., head of clinical development, Quintiles Asia Pacific. "We are projecting continued strong growth in the future, and this new facility gives us the room we will need. The new location also will allow us to work more efficiently, share best practices and deliver truly turnkey solutions to our customers."
Quintiles' Central Lab and its Clinical Development Services (CDS) offices will occupy 80,000 sq. ft. of space in the Cintech IV building now under construction in Singapore's Science Park One. The move is planned for 3Q09. The company has also opened an office in Jakarta and has recently expanded offices in Manila, Taipei, Seoul, Kuala Lumpur, Bangkok, Sydney and Hong Kong. In Singapore, Quintiles has about 225 employees, occupying 40,000 sq. ft. of space in three locations. The new location has a capacity of about 400.
Posted on September 11, 2008 @ 09:29 am
BioReliance Corp. has expanded its Rockville facilities and staff to accommodate the growing demand for its genetic toxicology testing services. BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services to the pharmaceutical and biopharmaceutical industries.
The expanded gene tox facilities features new labs and additional scientific staff for these services. In March 2008, the company restructured its toxicology and LADS services, forming a new business unit — Toxicology and LADS — headed by Darryl L. Goss, vice president.
Government regulations require gene tox testing to identify the potential of drugs, chemicals and other products to damage DNA. With pharmaceuticals, these tests are used throughout the drug development process, including discovery, lead optimization, preclinical safety testing and to further investigate mechanism of action to help characterize human risk.
“Expanding the facility is in response to the growing needs of the industry. Our dedicated staff works closely with regulatory agencies and customers to ensure faster and safer drug development. The additional capacity will allow us to serve our client’s screening and regulatory required testing needs faster and more efficiently with the highest degree of precision,” said Mr. Goss.
Posted on September 11, 2008 @ 09:27 am
Akorn, Inc. has entered into a 10-year exclusive contract manufacturing supply agreement with an undisclosed ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the development, manufacturing and supply of two new ophthalmic products. The estimated manufacturing revenue from this agreement is $2–$3 million. The two products are targeted for launch in mid-2009.
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “This agreement reflects Akorn’s commitment to expanding our contract pharmaceutical manufacturing business unit.”
Posted on September 10, 2008 @ 10:31 am
Sanofi-Aventis has named
Chris Viehbacher chief executive officer of the Group, effective December 1st, 2008. He succeeds Gerard Fur, who will continue to provide general management of the Group in the scientific area.
Mr. Viehbacher has spent 20 years of his career within the GlaxoSmithKline Group, where he has held a variety of senior positions, including general manager of France and later of Europe. He most recently served as president Pharmaceutical Operations, North America and as a member of the board.
Posted on September 10, 2008 @ 09:28 am
Cellzome, Inc. and
GlaxoSmithKline entered a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases. The alliance gives GSK access to Cellzome's expertise in identifying and developing selective kinase inhibitors and its Kinobeads technology, which screens compounds in a physiological setting and is designed to improve the predictability of these drug candidates in clinical testing. Kinases are key molecular switches in cellular signaling events with a central role in many inflammatory responses. Selective inhibitors offer a different therapeutic approach to diseases such as rheumatoid arthritis or multiple sclerosis.
Under the agreement GSK has exclusive options to license drug candidates from Cellzome's kinase programs directed against four identified targets, and three additional targets to be identified by both parties. Cellzome will use its Kinobeads technology to discover small molecule inhibitors of these targets, and then will develop the most promising candidates through a clinical proof of concept trial, unless GSK elects to exercise its option earlier. In this case GSK would have an exclusive option to license all product candidates from that program. GSK would then assume full responsibility for further clinical development and commercialization on a worldwide basis. Cellzome is eligible to receive success-based milestones as product candidates are advanced and retains the right to continue the development and commercialization of candidates GSK chooses not to develop.
Cellzome will receive upfront payments of $25.3 million comprised of both cash and equity and is eligible for as much as $208 million per program in potential development, regulatory and commercial milestones, in addition to sales-based royalties.
Jose Carlos Gutierrez-Ramos, Ph.D, senior vice president and head of the Immuno-Inflammation Centre of Excellence for Drug Discovery of GSK said, "GSK is committed to becoming a world leader in immuno-inflammation drug discovery by finding transformative medicines through internal efforts and external collaborations. We are excited to be working with Cellzome to discover and develop improved approaches to existing biologic therapies, which cannot access intracellular signaling mechanisms. Cellzome's Kinobeads technology will provide a distinct advantage because it uses native kinases directly isolated from human cells and tissues."
Posted on September 10, 2008 @ 09:26 am
Azopharma Product Development Group announced the successful FDA audit of its
Cyanta Analytical Laboratories facility in Maryland Heights, MO. The audit occurred from Aug 19-20 and produced no 483s or other major observations.
Mr. Phil Meeks, chief executive officer of Azopharma, commented, “We are very pleased with the results of the recent FDA audit. It demonstrates our commitment to quality systems and personnel.”
Cyanta Analytical Laboratories is a member of the Azopharma Product Development Group and provides analytical testing to the pharmaceutical, biotechnology and medical device industries. The Cyanta facility was previously audited in 2006 which also produced no 483s or major observations.
Posted on September 10, 2008 @ 09:24 am
Charles River Laboratories has completed the acquisition of privately held
NewLab BioQuality AG, a Dusseldorf, Germany-based provider of safety and quality control services to biopharmaceutical clients. NewLab joins Charles River Biopharmaceutical Services, which provides services to support the development and manufacture of biologics.
James C. Foster, chairman, president and chief executive officer of Charles River, said, "The acquisition of NewLab further strengthens our portfolio of essential products and services to help our clients accelerate drug development. NewLab enhances the scientific depth, geographic scope and client base of Charles River’s global biopharmaceutical services offering to support the rapidly growing market for biologic drug compounds. We are pleased to welcome NewLab BioQuality to the Charles River family."
Posted on September 9, 2008 @ 09:01 am
Pfizer will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. NDA and the European MAA.
Following feedback from regulatory authorities, the company plans to conduct an additional Phase III trial with dalbavancin for the treatment of adults with complicated skin and skin structure infections caused by Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus), a virulent and potentially deadly bacterium. The global study will generate additional data to support planned future regulatory submissions. A pediatric program with the drug is also planned.
“After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections,” said Dr. Mark Kunkel, Pfizer’s global medical therapeutic area leader for anti-infectives and HIV. “Dalbavancin represents a potential important treatment advance and Pfizer is committed to ongoing research of its use in patients who suffer from serious skin infections, including those caused by MRSA.”
Pfizer acquired the drug in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.
Posted on September 9, 2008 @ 08:59 am
Bilcare Global Clinical Supplies has enhanced its global Phase III capabilities. The company has upgraded its Kalish large-scale bottling line at its U.S. facility and invested in new Pentapack blistering technology for expanded packaging capabilities in America and Europe.
The Pentapack CT1200L system allows the company to package high-volume runs for large-scale clinical trials and stability tests. This technology provides additional flexibility in trial design and execution to meet individual client needs. The Pentapack system enables the design of blister packaging configurations online using Trialpack Designer II packaging design software, which can be implemented immediately for production. According to the company, the system’s automation significantly reduces manufacturing times and creates a 21 CFR Part 11-compliant electronic paper trail that documents changes from design to production through quality control.
“Bilcare GCS has built its reputation on providing customers with the highest quality research services and clinical supplies delivered on time, every time,” said Vince Santa Maria, president of Bilcare GCS, Americas. “The Pentapack and the expanded Kalish lines are key components to taking Bilcare’s Phase III clinical trial services to the next level by leveraging state-of-the art packaging technologies to deliver superior quality products in a highly flexible and efficient manner. These latest investments are further proof of Bilcare’s long-term commitment to serving the industry with exceptional quality and service beyond compliance.”
Posted on September 9, 2008 @ 08:54 am
West has completed expansion work at its Kinston, NC manufacturing facility. The expanded plant provides additional compounding and custom manufacturing capabilities and will bring more than 150 new jobs to Kinston and surrounding communities. The facility was badly damaged by an explosion in January 2003.
“The opening marks the culmination of West’s promise to rebuild our Kinston facility and to come back stronger than ever,” said West’s chairman and chief executive officer, Donald E. Morel, Jr., Ph.D. “We are grateful to the Kinston community, Lenoir County and the state of North Carolina for sharing in this vision and we look forward to continued growth and success.”
“West is extremely pleased to announce the completion of this new state-of-the-art compounding and molding facility,” said Jimmy Adams, plant manager, West, Kinston. “This celebration reflects the many faces of the Kinston community.”
Posted on September 9, 2008 @ 08:52 am
Thierry Amat has been appointed chief financial officer of
Aptuit, Inc. Mr. Amat will oversee the financial and information technology departments. He has more than 20 years of financial management experience in publicly traded companies as well as knowledge of the pharmaceutical and chemical industries. Mr. Amat most recently served as the chief financial officer of Sodexho Inc., a publicly traded food services company. He began his career at Rhone-Poulenc, where he held positions of increasing responsibility, and later worked as vice president and controller for global R&D at Aventis Pharmaceuticals.
“Thierry’s global experience and proven leadership will be a significant addition to Aptuit’s management team,” stated Timothy C. Tyson, executive chairman and acting chief executive officer of Aptuit. “His proven successes in all phases of financial management will be a great asset as we move into the next phase of growth. Over the next 12 to 18 months we will make several strategic advances in our efforts to transform customer access to real-time data and truly define the shift toward a paperless business model via programs, such as Clinicopia Connect and Aptuit Fusion.”
Posted on September 8, 2008 @ 08:43 am
The FDA has granted supplemental NDA approval for
Akorn, Inc.'s IC-Green for Injection, USP. This approval is Akorn’s first lyophilized product approval for manufacture in its Decatur, IL production facility.
The company has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at its Decatur facility. In December 2007, the company announced successful results of an FDA pre-approval inspection (PAI) for lyophilized products.
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “We are very excited to announce the FDA approval of our first Akorn-manufactured lyophilized injectable product. We intend to commercialize our lyophilization manufacturing capabilities by developing an internal ANDA injectable product line and by expanding our contract pharmaceutical manufacturing business segment to include lyophilized injectable products.”
Posted on September 8, 2008 @ 08:41 am
Bosch's Packaging Technology Division plans to acquire
Paal Verpackungsmaschinen GmbH & Co. KG, based in Remshalden near Stuttgart. The purchase price was not disclosed.
Paal is a packaging and automation specialist that develops, manufactures, and sells lines for secondary and multiple unit packaging using various materials such as paper, solid fiber board, compact and corrugated board. The company has a range of products for worldwide distribution to the food and cosmetics industries as well as manufacturers of technical products.
With the acquisition, Bosch adds to its systems business and product portfolio with secondary and multiple unit packaging. Paal products will become available through Bosch's global distribution network and also enables Bosch to establish business contacts with new sectors of the non-food segment.
"Paal has impressive systems competence which we intend to utilize for growth in this sector. This involves deriving benefits from the knowledge and expertise of Paal associates," said Friedbert Klefenz, president of the Bosch Packaging Technology division.
"Under the Bosch umbrella, we will gain access to new markets and technologies. This will offer excellent prospects for driving our business forward and achieving optimum growth," said Claus Paal, executive director of Paal.
Posted on September 8, 2008 @ 08:36 am
The FDA has accepted data submitted from
Bridge Laboratories' Beijing facility on behalf of a U.S. biotech client. The GLP nonhuman primate toxicology study data was generated and submitted as part of an IND package to the FDA. Bridge’s Beijing facility was built to conduct GLP studies in support of worldwide regulatory submissions.
“The FDA’s acceptance of this data validates the wisdom of conducting preclinical research in China for clients looking to complete studies economically," said Tom Oakley, president and chief executive officer, Bridge Laboratories. “We are pleased about what this says about the quality of our work in China – that it clearly meets Western standards – and what it means to companies seeking cost-effective GLP IND-enabling work,” Oakley continued.
Bridge is in the process of developing a second facility in Beijing, which is expected to be complete in 4Q09. The new facility will be adjacent to the existing one and will quadruple the available lab space.
Posted on September 5, 2008 @ 09:08 am
Cirrus Pharmaceuticals, Inc. has expanded its current capacity for stability storage with the addition of 3 LUWA walk-in stability chambers. The company will add three large capacity, cGMP compliant chambers, each with 1,100 cubic feet of storage space. The new additions include: 25°C / 60% RH storage (long-term conditions); 30°C / 65% RH storage (Intermediate conditions); and 40°C / 75% RH storage (Accelerated Conditions)
“With an increase in our existing and new client sponsor requests for long-term stability storage and testing, expanding our capacity is a logical investment in Cirrus Pharmaceuticals’ progression as a contract research service provider,” said Jean-Marc Bovet, Ph.D. executive senior vice president.
With the expansion, Cirrus will be able to increase its current capabilities of formulation and product development services for various dosage forms including inhalation, nasal, parenteral, oral, topical and transdermal. The expansion also enhances its release testing and stability testing in support of clinical trials, IND and NDA submissions. Validation of the chambers, including temperature and humidity mapping and monitoring systems, are scheduled for completion by November of this year.
Posted on September 5, 2008 @ 09:05 am
WellSpring Pharmaceutical Corp. has expanded its consumer health care product line with the acquisition of several OTC products from
McNeil Consumer Healthcare Division. In an all-cash transaction, WellSpring has purchased U.S. rights to Micatin (antifungal), Emetrol (anti-nausea), and Gelusil (antacid), and the Canadian rights to Micatin, Gelusil, and Glycerin Suppositories (laxative).
In the U.S. the new brands give WellSpring a base in the consumer healthcare market where the company plans to launch its OTC skin care products, Glaxal Base and Barriere. The company also provides contract manufacturing services.
"With consumers taking more responsibility for their own health, this segment of the pharmaceutical market holds substantial promise for growth," said Dr. Robert A. Vukovich, WellSpring's president and chief executive officer. "Having marketed OTC products in Canada for many years, our experience in growing this pharmaceutical category should prove to be very beneficial. WellSpring expects to undertake an aggressive marketing effort to re-invigorate these products and expand their distribution," Dr. Vukovich said.
Posted on September 5, 2008 @ 09:04 am
Patheon
3Q Revenues: $195.0 million (+18%)
3Q Loss: $14.7 million (loss of $63.1 million in 3Q07)
YTD Revenues: $545.1 million (+15%)
YTD Loss: $38.3 million (loss of $87.1 million YTD07)
Comments: Commercial Manufacturing revenues were up 15% to $157.3 million driven by strong growth in the European business. Revenue increased at all North America locations except Cincinnati, which was impacted by customer related raw material supply constraints. Pharmaceutical Development Services revenues were up 32% to $37.7 million, with growth in both North America and Europe. Repositioning expenses in the quarter were $6.7 million for severance accruals for 2009 consolidation plans for the York Mills and Whitby operations in Canada, and downsizing expenses related to establishing the Caguas, PR site as a satellite plant to the Manati operation.
Posted on September 5, 2008 @ 09:03 am
Metrics, Inc. is now offering microbiology-testing services to the pharmaceutical industry following its recent $18-million, 47,000-sq.-ft. expansion, which doubled the size of its facility and expanded its service capabilities.
As part of its new microbiology lab, the company has brought antibiotic assay and sterility testing online, enhancing its full microbiological support of sterile products. The company routinely performs bacterial endotoxin and particulate matter testing on parenterals. Metrics’ facility addition also includes four new fully operational analytical labs, validated and ready to handle projects; stability storage with state-of-the-art environmental specialties chambers with redundant mechanical systems and strictly limited personnel access; and a dedicated cytotoxic and potent compound laboratory.
“Offering our clients all the services they need under one roof has been a long-time goal for us,” said Phil Hodges, president. “We’re glad we can add value to the relationships we’ve developed with our clients, and know these services will make Metrics even more competitive when it comes to attracting new clients.”
Posted on September 4, 2008 @ 09:31 am
Merck Serono has entered into an agreement with Ablynx to discover and develop Nanobodies against two targets in oncology and immunology. The agreement includes an upfront cash payment to Ablynx of $14.5 million.
Nanobodies are a new class of therapeutic proteins that contain the structural and functional properties of naturally occurring single domain antibodies. The partners will collaborate to research and develop Nanobody-based therapeutics against two disease targets.
Under the terms of the agreement, the companies will share all R&D costs. Ablynx will be eligible to receive half of the resulting profits from each program, depending on its participation. Ablynx will have an option to opt-out of the development programs, in which case the company would be eligible to receive either a reduced profit share, or milestones and royalties on potential sales. Total development and commercial milestones could reach as much as $470 million depending on product approvals and multiple indications in all major markets.
"We are very pleased to enter into this partnership with Merck Serono, a recognized global leader in the treatment of oncology and immunology therapies. This type of risk and reward sharing collaboration underlines Ablynx's maturing capabilities and collaboration strategy, whereby we can leverage on the resources and expertise of our partners to advance Nanobodies more quickly into the clinic while retaining an equal share of the value created," commented Dr. Edwin Moses, chief executive officer and chairman of Ablynx.
Posted on September 4, 2008 @ 09:26 am
SAFC Pharma, a member of the Sigma-Aldrich Group, plans a $30 million expansion to its Madison, WI facility to increase its capacity to produce commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs). The investment includes the purchase of 15 acres of land in Verona, WI near its existing HPAPI production site, where the company will build a new 45,000-sq.-ft. manufacturing facility that will house commercial scale reactors capable of producing HPAPI batch sizes of 4,000 liters. Construction is expected to be complete by year-end 2009.
The facility's design will maximize efficiencies and safe handling in high potency development and adhere to Category IV standards. The site will seek Safebridge certification upon completion. The facility will include state-of-the-art development labs, a 150-liter mini-processing plant and two large-scale cGMP manufacturing suites. The building will have quality control labs, a potent compound packaging area and warehouse and office space, as well as space to expand.
"Currently, there is minimal manufacturing capacity to support market demand for large-scale HPAPI production," said Dave Feldker, SAFC Pharma vice president of sales and manufacturing, U.S. "We are committed to providing customers with the best possible HPAPI manufacturing services, and our new investment at Madison will enable us to continue to meet the increasing demand for HPAPI production and put us at the forefront in manufacturing commercial- scale high potency materials."
Posted on September 4, 2008 @ 09:24 am
Steven R. Hagen, Ph.D. has been promoted to vice president of pharmaceutical development and manufacturing,
AMRI. He will report to chairman, president and chief executive officer, Thomas E. D’Ambra, Ph.D.
Luckner G. Ulysse, Jr., Ph.D. has been promoted to vice president, chemical development from senior director, chemical development and small scale cGMP, reporting to Dr. Hagen.
Dr. Hagen previously served as vice president for quality and analytical chemistry, responsible for regulatory affairs for all AMRI locations. In this expanded role, he will assume leadership for the company’s chemical development, small scale cGMP manufacturing, and large scale commercial manufacturing business components, including operations in Albany/Rensselaer and Syracuse, NY and Hyderabad, India, as well as the company's large scale manufacturing operations in Rensselaer and Aurangabad, India.
Dr. Hagen joined the company in 2005 as senior director of analytical quality services. Prior to AMRI, he spent more than 10 years at Pfizer in positions of increasing responsibility culminating in director of analytical research and development at Pfizer’s Global R&D Division. Before Pfizer, he managed the analytical activities at Ribi ImmunoChem Research, Inc. in support of R&D, production and quality control.
Dr. Ulysse, in addition to managing the company’s small scale cGMP and chemical development operations in Albany/Rensselaer and Syracuse, will integrate international development operations, including AMRI operations in Hyderabad, India. Prior to joining the company in 1999, Dr. Ulysse was senior research chemist at Advanced ChemTech Inc.
“We are pleased to announce the promotions of Drs. Hagen and Ulysse into these expanded leadership roles at AMRI,” said Dr. D’Ambra. “Both of these individuals have consistently demonstrated the ability to achieve and deliver positive results from their teams and operations, as evidenced by the continued improvements to efficiencies and financial results in their departments. We believe they will continue to be drivers of successful change and growth. We wish both Drs. Hagen and Ulysse success in their new positions.”
Posted on September 3, 2008 @ 09:25 am
Pfizer and
Medivation, Inc. have entered into an agreement to develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. Dimebon currently is being studied in a confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease.
Under the terms of the agreement, Medivation will receive an upfront cash payment of $225 million and is eligible to receive as much as $500 million based on development and regulatory milestones, as well as additional commercial milestone payments. The two companies will collaborate on the Phase III program and regulatory filings in the U.S. and will share all U.S. development and commercialization expenses along with profits/losses on a 60%/40% (Pfizer/ Medivation) basis. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.
Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation royalties on commercial sales outside of the U.S. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act.
Dimebon is an orally available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer’s disease and Huntington’s disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections.
Posted on September 3, 2008 @ 09:23 am
Millipore Corp. and
Agilent Technologies have formed a collaboration to develop ChIP (chromatin immunoprecipitation) kits for the epigenetics research market. The kits will be designed to improve productivity for protein research and simplify the way genetic information is studied.
ChIP is a technique that helps researchers understand the relationship between DNA and the proteins that impact gene regulation. The collaboration will combine Millipore’s antibody expertise, ChIP kits and reagents, with Agilent’s expertise with microarrays and data analysis solutions.
“This collaboration brings together two industry leaders to improve scientific workflows for epigenetic researchers,” said Geoffrey Crouse, vice president of Millipore’s Life Science Strategic Business Unit. “Our long history of leadership in the ChIP market coupled with Agilent’s leadership in DNA microarrays will enable us to help scientists push the frontiers of epigenetic research. We expect to help epigenetics researchers minimize the barriers of entry into chromatin state mapping, readily obtain reproducible genomic profiling data, and overcome the traditional challenges of ChIP assays.”
“We are very pleased to be working with Millipore to provide an end-to-end solution for studying the complexities of DNA-protein interactions and binding,” said Yvonne Linney, Ph.D., Agilent vice president and general manager, Genomics. “Our two companies are solidly positioned to fuel discoveries in this rapidly growing field.”
Posted on September 3, 2008 @ 09:20 am
Pall Corp. has acquired
GeneSystems, a privately held biotechnology company that has developed its own molecular diagnostics platform. The acquisition expands Pall's Total Fluid Management (TFM) capabilities in the biopharmaceuticals process monitoring market with GeneSystems' rapid microbiological detection equipment and disposables.
Process monitoring includes the analytical tests required during biopharmaceuticals manufacturing for environmental monitoring, in-process control testing and finished product release testing, which are increasingly being scrutinized by regulatory agencies and support initiatives such as Process Analytical Technology (PAT).
GeneSystems gained market recognition for its quantitative Legionella diagnostic platform. GeneSystems has developed systems for the diagnosis of a range of pathogens, including food safety testing focused on E. coli. These systems employ advanced sample preparation methods and real-time polymerase chain reaction (PCR) technology to enable fast and high throughput along with high reproducibility analysis of multiple DNA targets. Real-time PCR detects small quantities of specific microorganisms and provides results within hours.
“We are excited by this acquisition and the increased opportunities it presents for our pharmaceutical, biotechnology, environmental monitoring, quality control and diagnostics programs,” said Eric Krasnoff, Pall chairman and chief executive officer. "Customers seek better tools for rapid testing and process monitoring. GeneSystems expands our ability to provide Total Fluid Management to meet customer's raw materials, production, testing and environmental requirements. GeneSystems’ unique technologies complement Pall's markets and global reach.”
"It is wonderful to join Pall and have the opportunity to expand on a global scale the very significant customer advantages that our team has achieved, diligently and creatively, during the last few years,” said Darryl Spurling, chief executive officer of GeneSystems.
Posted on September 2, 2008 @ 02:34 pm
Shionogi & Co., a Japan-based pharmaceutical company, plans to acquire
Sciele Pharma for $1.1 billion. The planned bid is aimed at expanding Shionogi's sales network into the U.S. "As we have moved ahead on improving our product pipeline, we have been faced with increasingly imminent challenge of getting a hold of a sales network in the world's largest market," Shionogi president, Isao Teshirogi, said. Mr. Teshirogi added that Sciele should also help the company gain approval for new drugs from U.S. regulators.
Sciele Pharma specializes in branded prescription products focused on cardiovascular, diabetes, women's health and pediatrics. Sciele's biggest blood-pressure drug Sular faces generic competition. Sciele is now promoting newly approved forms of Sular in an effort to counter potential generic competition of the older version of the drug. Shionogi's biggest product is cholesterol drug Crestor, through a license fee from AstraZeneca.
Posted on September 2, 2008 @ 02:33 pm
InterMune, Inc. earned a $15 million development milestone under its collaboration with
Roche for the hepatitis C virus (HCV) NS3 protease inhibitor compound ITMN-191 (R7227), currently in a Phase Ib combination trial with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).
Under the terms of the 2006 collaboration agreement, Roche will take over primary responsibility for Phase II trials and for completing the global development and registration program for ITMN-191.
Nick Cammack, Ph.D., global head of the virology disease biology area, Roche, said, "Protease inhibition is a crucial aspect of our HCV strategy, which is focused on developing clinically differentiated medicines for patients. Our continued enthusiasm for ITMN-191/R7227 underscores our confidence in InterMune and we now plan to rapidly move the program into Phase II development."
Dan Welch, chairman, chief executive officer and president of InterMune, said, "We are very pleased to have led the preclinical development, conducted three Phase I trials and with Roche, optimized the manufacturing of ITMN-191 active pharmaceutical ingredient (API) since the collaboration was announced less than two years ago. We look forward to the continued strong relationship with Roche as we together develop protease inhibitor therapies in combination with current standard of care and with other direct antiviral agents."
Posted on September 2, 2008 @ 02:31 pm
Patrick O'Connor, Ph.D., has been appointed vice president, research,
Halozyme Therapeutics.
Michael J. LaBarre, Ph.D., has been appointed vice president, product development, and
James E. Cartoni has been appointed vice president, legal.
"We are delighted that seasoned executives such as Patrick, Michael, and Jim have joined the team. Successfully recruiting executives of this caliber underscores our commitment to finding exceptional talent, and also reflects the high level of excitement Halozyme is generating in the biotech industry," said Jonathan Lim, M.D., president and chief executive officer of Halozyme Therapeutics. "Their broad collective experience in drug development, formulation, analytical methodology, manufacturing, and the legal aspects of biotechnology brings further breadth and depth to our leadership team. All three executives will work closely with our senior management to enable Halozyme to achieve its business objectives."
Dr. O'Connor will be responsible for leading the company's multiple biology and chemistry research programs. He joins the company from Ardea Biosciences where he was senior vice president and chief scientific officer. Prior to joining Ardea, Dr. O'Connor served in various executive research positions at Pfizer Global R&D and Agouron Pharmaceuticals (which was bought by Pfizer) from 1998 to 2007. His last position with Pfizer as vice president, research therapeutic area head, global oncology, included responsibility for setting the overall global oncology research strategy and overseeing all aspects of oncology research. While at Pfizer, Dr. O'Connor also built and oversaw the diabetes and obesity research groups at the La Jolla campus.
Dr. LaBarre will oversee all of Halozyme's product development efforts. He has expertise in chemistry, manufacturing and controls (CMC) based on his extensive experience in the biotechnology industry for both biologics and small molecules. Dr. LaBarre previously served as vice president of product development at Paramount BioSciences, where he led the CMC efforts for all of the product development programs within the company's portfolio. Prior to joining Paramount, Dr. LaBarre served in various R&D positions at Biogen Idec where he had responsibility for analytical and formulation development, protein purification, and biochemical characterization supporting numerous IND and BLA submissions. His last position with Biogen Idec was director of analytical and protein biochemistry. Dr. LaBarre also spent two years at Vical, Inc. in the analytical methods development group.
Mr. Cartoni will oversee various legal matters, including the negotiation and completion of agreements, corporate governance matters, securities compliance, and the coordination and management of outside legal counsel. Prior to joining Halozyme, Mr. Cartoni was a partner at DLA Piper, where he represented numerous public and private companies in areas such as financing transactions, corporate compliance, mergers & acquisitions and general business matters. DLA Piper is Halozyme's primary outside corporate counsel and Mr. Cartoni has represented Halozyme since 2004.
August 2008
Posted on August 29, 2008 @ 08:32 am
Novartis has discontinued development of Aurograb, an add-on therapy to antibiotics that was being assessed for use in treating deep-seated staphylococcal infections, following a review of recent Phase II results showing a lack of efficacy.
Novartis gained rights to the compound in 2006 through the acquisition of NeuTec Pharma. An intangible asset impairment charge of approximately $235 million, which is the full amount allocated to this project, will be taken in the 3Q08 in the Pharmaceuticals Division.
Phase III trials and submission preparations continue for Mycograb, another development compound acquired with NeuTec that is being studied as an add-on therapy to antifungal agents in treating invasive candidiasis and other severe fungal infections.
Posted on August 29, 2008 @ 08:26 am
Pharmos Corp. will cease operations in Rehovot, Israel, effective October 31, 2008. The company plans to manage the activities currently based in Rehovot out of its U.S. headquarters in Iselin, NJ.
The research programs in Israel include the CB2 receptor selective library of compounds, including preclinical development of PRS-639,058 for neuropathic pain. The company is also working on finishing up a Phase IIa trial for its 3% diclofenac NanoEmulsion cream for use as a topical treatment for osteoarthritis pain.
The company is seeking a partner to lead both operating and funding of the research programs in Israel. The Rehovot senior management team of Iris Alroy, Ph.D. and Arnon Aharon, M.D. will remain available to support ongoing business development and existing collaborations as consultants.
Posted on August 28, 2008 @ 08:39 am
Valeant Pharmaceuticals and
GlaxoSmithKline have entered into an exclusive worldwide collaboration for the investigational drug retigabine, a neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown efficacy and safety in two Phase III trials in patients with refractory epilepsy receiving treatment with as many as three antiepileptic drugs (AEDs). The two companies plan to file a NDA in the U.S. and a MAA in Europe by early 2009. The drug is also being studied in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.
Under the terms of the agreement, Valeant will grant GSK worldwide development and commercialization rights to retigabine, VRX698 and the other compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million. Valeant is eligible to receive as much as $545 million based on certain regulatory, development and commercialization milestones, as well as the development of additional indications for retigabine. Valeant will co-commercialize and share as much as half of the profits in the U.S., Canada, Australia, New Zealand and PR, and will receive as much as a 20% royalty on sales outside those regions. The two companies will share global R&D expenses for retigabine, and GSK will fund the development of VRX698 and the other back-up compounds from the program. Valeant could receive an additional $150 million based on the achievement of certain milestones for VRX698 and the back-up compounds, and double-digit royalties on worldwide sales.
“We were pleased with the significant interest shown in retigabine and we have selected GSK as a collaborator because we believe they are ideally suited and strongly committed to the continued development of this important compound,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “GSK’s development expertise and strong commercial infrastructure will be critical to maximizing the worldwide potential of retigabine. We believe this collaboration will strengthen our ability to bring this medicine to patients suffering from epilepsy and a variety of other conditions.”
“GSK is looking forward to working with Valeant to provide important medicines like retigabine to the medical community and to the patients we serve,” commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. “There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications. We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK’s portfolio.”
Posted on August 28, 2008 @ 08:36 am
Genentech, Inc. will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in collaboration with
Curis, Inc. and will be the sponsor of this study.
GDC-0449 will be evaluated in approximately 100 patients in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized to receive either GDC-0449 or a placebo comparator and will be separated based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events.
“We believe that the dysregulation of developmental pathways such as Hedgehog may play a role in the formation or recurrence of cancer. Therefore, we are hopeful that a Hedgehog inhibitor, such as GDC-0449, may be a useful therapeutic tool in preventing cancer from returning in these ovarian cancer patients and may prove useful as a maintenance therapy,” said Curis president and chief executive officer Dan Passeri. “GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008.”
Posted on August 28, 2008 @ 08:34 am
David Blumberg has joined KPMG LLP as a principal and advisory sector leader for the Pharmaceutical Industry practice, based in the firm’s Philadelphia office.
In his new role, Mr. Blumberg provides a full array of advisory services to pharmaceutical and life sciences clients. He has significant experience working in the global pharmaceutical space, including market evaluations, launch/entry strategy, product strategy, business transformation, performance improvement, strategic planning and merger integration.
Prior to joining the company, Mr. Blumberg served as executive vice president at I-Many, a provider of advanced Enterprise Contract Management (ECM) solutions, where he was responsible for all professional services, customer support, sustaining engineering functions, as well as formulating and directing marketing strategies in the Life Sciences and Healthcare business line.
He also served as global pharmaceutical and medical products industry leader for Accenture, where he serviced client accounts and led the industry team in developing strategy, positioning, awareness, thought capital, alliances and media/marketing programs.
Posted on August 27, 2008 @ 09:32 am
Chiltern has fully integrated its two early Phase units into a single operation branded as Chiltern Early Phase. This follows the acquisition of Drug Development Solutions (DDS) in February.
Chiltern Early Phase provides early phase services for the pharmaceutical industry through its two units in Slough (just outside of London) and Dundee, Scotland. Chiltern Early Phase has a total of 72 beds, 42 of which are based at Ninewells Hospital in Dundee and can cover all therapeutic areas and all types of clinical pharmacology studies, with specialization in first in man, drug photosensitivity, drug-drug interaction, Japanese bridging and vaccine studies.
Glenn Kerkhof, Chiltern's chief executive officer, said, "When we created Chiltern Early Phase, our vision was to develop a brand that would be synonymous with quality and service excellence. We now have the team, organization and facilities to deliver on this vision and provide a truly expert Early Phase service at reasonable cost."
Dr. Brian Sanderson, medical director of Chiltern Early Phase commented, "I am delighted to see the integration completed so thoroughly and ahead of schedule. We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialization such as diabetes and cardiovascular medicine. We are also looking forward to forging academic links to provide specialist studies involving new biomarkers."
Posted on August 27, 2008 @ 09:30 am
Timothy C. Tyson has been appointed executive chairman and acting chief executive officer of
Aptuit, Inc. Michael A. Griffith, the company’s founder and chief executive officer since 2005, has resigned to pursue other opportunities.
“The board wishes to thank Mike for his outstanding success in creating a world-class organization that is a trusted partner to hundreds of innovative clients throughout the world,” said Tony Ecock, outgoing chairman of Aptuit’s board of managers. “With 2,700 employees working with more than 800 clients throughout the world, Aptuit has established a solid foundation for continued growth and success.”
Tim Tyson is the former chief operating officer, president and chief executive officer of Valeant Pharmaceuticals International, where he served from 2002-2008. Prior to Valeant, Mr. Tyson spent 14 years at GlaxoSmithKline, where he was president of global manufacturing and supply and ran Glaxo Dermatology and Cerenex Pharmaceuticals. He managed all sales and marketing for GlaxoWellcome’s U.S. operations. Mr. Tyson has also held executive positions at Bristol-Myers in commercial and technical operations and R&D. Previously he was a manufacturing manager for Procter & Gamble.
Posted on August 27, 2008 @ 09:28 am
Bristol-Myers Squibb and
Pfizer reported that an interim analysis of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement indicate that the primary endpoint of this study was not met.
The Phase III VTE prevention study known as ADVANCE-1 compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to the FDA-approved dose of Sanofi-Aventis' enoxaparin, 30 mg given twice daily. The primary efficacy outcome was the total of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause. The rate of the primary efficacy endpoint on apixaban was similar to enoxaparin (9.0% vs. 8.9%), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin, which was expected to be 16%, based on previous trials.
The companies are considering further studies with different protocols in preventing VTE in knee surgery and will not submit the U.S. filing for VTE prevention in 2009 as planned. Programs directed towards VTE prevention including EMEA registrational studies, treatment of VTE, and the prevention of stroke in atrial fibrillation continue as planned.
Full results of the ADVANCE-1 trial will be presented in December. Also, new Phase II data of apixaban in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC).
“Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban,” said Jack Lawrence, vice president, R&D, Bristol-Myers Squibb. “[The companies] anticipate that the results of APPRAISE-1 being presented at ESC will provide important insight into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary syndrome, which affects an estimated 2.7 million people around the world every year.”
Posted on August 26, 2008 @ 09:17 am
James J. Kramer, Ph.D., has been appointed vice president, Global Biologics Operations, a newly created position at
BioReliance Corp. Dr. Kramer joined the company in December 2007 as vice president, operations, U.S. Biologics. In his new position, his responsibilities will be expanded to include all operations at the company’s three facilities in Scotland, located in Glasgow, Stirling and Edinburgh, Scotland. He will continue to report to president, chief executive officer and chairman
David A. Dodd, and will be based at the company’s headquarters in Rockville, MD.
“Jim is an excellent choice to lead our global biologics operations as we aggressively proceed in developing our organization to more effectively serve our clients. His leadership will ensure that BioReliance remains highly competitive as we develop and expand our customer base globally,” said Mr. Dodd. “Since joining the organization, Jim has consistently demonstrated expertise in creating and leading a highly customer-oriented management team. Our focus is to provide the highest levels of client support and service through operational excellence, and I am confident that under Jim’s direction we will achieve that goal.”
Prior to joining BioReliance, Dr. Kramer served as senior vice president/general manager, Talecris Plasma Resources, Talecris Biotherapeutics. Previously, he served as vice president, Global Manufacturing Operations at Serologicals Corporation, and held management positions at Ortho-Clinical Diagnostics, Inc. (a Johnson & Johnson Company), and Pacific Hemostasis Division of Curtin Matheson Scientific.
BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services.
Posted on August 26, 2008 @ 08:48 am
Morphotek, Inc., a subsidiary of Eisai Corp. of North America, has opened clinical sites in the EU as part of its Phase II study of MORAb-009. A monoclonal antibody to mesothelin, MORAb-009 is being studied as a first-line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.
Morphotek has currently qualified 33 clinical sites in the U.S. and Canada to conduct its Phase II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval in Spain, Belgium and Germany and 17 sites have been qualified in these countries. Regulatory approval for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the U.S.
“We are extremely pleased to receive approval for the MORAb-009 Phase II trial sites in the EU,” said Martin D. Phillips, M.D., chief medical officer of Morphotek. “A distinguished group of clinical investigators treating pancreatic cancer patients throughout the EU have expressed an interest in novel biologic therapies for this typically fatal disease. We look forward to the possible involvement of additional European clinical sites for this compound as well as others in our pipeline.”
MORAb-009 is an IgG1 antibody that recognizes a cell surface glycoprotein called mesothelin, which is over-expressed on a number of epithelial-derived cancers. The antibody has been found to elicit anti-tumor effects via blockade of mesothelin to bind to its ligand present on neighboring cells and immune-effector responses. Phase I studies of the antibody in patients found the molecule to be well tolerated at, or below, the maximum tolerated dose and clinical observations from those studies suggested anti-tumor responses in a number of patients.
Posted on August 26, 2008 @ 08:19 am
Algorithme Pharma has acquired Simbec Research in Merthyr Tydfil, Wales. The move gives the Laval, Quebec-based clinical research and bioanalysis provider, a foothold in Europe, and comes six weeks after the company's acquisition of a Baltimore, MD-based CRO.
Simbec has provided contract clinical research services to large pharmaceutical R&D companies for more than 30 years. The staff of the new Algorithme Pharma division in the UK is composed of a core team of approximately 100 employees who will join those already working at company locations in Montreal, Laval and Baltimore.
"Given the considerable growth of our 'international' clientele, it became necessary to acquire a location in Europe in order to better serve our fast-growing market once we had expanded to the U.S. The acquisition of this strategically-located and highly-respected clinical research centre is the first step in our European expansion strategy and provides us with an important base for future growth in the European market," explained Algorithme president and chief executive officer, Louis Caillé.
The Phase I and IIa UK location for clinical research includes a 38,000-sq.-ft. facility with 48 beds, all used by the Intensive Monitoring Unit. With this addition, Algorithme will increase its production capacity in Phase I and IIa drug development clinical trials.
Posted on August 25, 2008 @ 10:06 am
Dr. Michael D. Ruff has recently been appointed vice president of pharmaceutical development at
Metrics, Inc. He recently received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy.
Dr. Ruff completed his Pharm.D. degree shortly after becoming the ninth person in the world to earn the new Certified Pharmaceutical Industry Professional (CPIP) credential, awarded by the International Society for Pharmaceutical Engineering’s Professional Certification Commission and is the first competency-based international certification for pharmaceutical professionals. Those who qualify for the credential demonstrate global competency through education, experience and rigorous examination.
Dr. Ruff has been with Metrics for 11 years, where his responsibilities have included providing formulation development, clinical trial material manufacture and consultation services to clients. “In his many years here at Metrics, Mike has consistently demonstrated a personal commitment to excellence, including his pursuit of continuing education that allows him to remain at the forefront of industry knowledge and technology,” said
Phil Hodges, president. “We congratulate Mike on earning his doctorate.”
Dr. Ruff has been a member of ISPE since 2005 and is a registered pharmacist with more than 20 years’ experience in developing new chemical entities with a focus on oncology, central nervous system and anti-viral drugs. He holds several U.S. patents for pharmaceutical applications and has authored numerous technical papers. He also is a member of the American Association of Pharmaceutical Scientists.
Posted on August 25, 2008 @ 10:00 am
The FDA has approved
Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.
The FDA approval of Nplate was based on efficacy and safety results from two Phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83% of treated patients, and platelet counts were raised and sustained in these six-month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications.
Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the U.S. and is considered an unmet need by the FDA.
“Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-term use due to side effects and tolerability issues,” said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.”
Said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president of R&D, “The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies.”
Nplate was also approved for ITP by Australia’s Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory approval of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the EU (2005), Switzerland (2005) and Japan (2006).
Amgen is continuing to study the long-term efficacy and safety of Nplate for which there is more than three years of follow up safety and efficacy data.
Posted on August 25, 2008 @ 09:54 am
Scott Neilson has been appointed to the position of chief operating officer of
AAIPharma. Mr. Neilson will be responsible for the company's global drug development services operations, reporting to chief executive officer and president
Dr. Ludo Reynders.
Mr. Neilson is an accomplished leader with over 25 years multi-functional experience in all phases of drug development on a global basis. During the past 10 years he has led the turnaround of two of the top six Global Central Laboratories, dramatically improving market share, revenues and profitability, according to an AAIPharma statement. He has also held senior operations positions in clinical research and has a broad spectrum of functional experience including finance, regulatory affairs, human resources and business development. His experience spans pharmaceuticals and CROs, having worked at MDS Pharma Services, LabCorp, Covance and SmithKline Beecham (now GlaxoSmithKline).
“As a company, we have made significant progress across the major lines of business over the last three years,” said Dr. Reynders. “Scott’s appointment underscores our commitment to continuing this progress and our goal of a global leadership position in the markets we serve."
Posted on August 22, 2008 @ 07:59 am
Sancilio & Company, Inc. (SCI) opened its newly expanded 2,000-sq.-ft. contract manufacturing facility. The GMP facility specializes in small batch manufacturing of tablets and capsules as well as packaging and labeling services.
The facility is adjacent to the company’s pharmaceutical laboratory, a climate-controlled facility for pharmaceutical, biotechnology and nutraceutical clients providing analytical services, which include formulation development, quality control, quality assurance and regulatory affairs.
According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “The new, fully cGMP compliant combined operation is FDA registered, and licensed for DEA Schedule 2, 3 and 4. The key attributes of both the manufacturing facility and the laboratory are rapid turnaround and competitive pricing.”
Nealie Newberger, Ph.D., vice president of laboratory services, said, “We anticipate that the addition of small batch contract manufacturing to our roster of services strategically positions the company as a full-service pharmaceutical and nutritional enterprise.”
Posted on August 22, 2008 @ 07:58 am
The Centers for Disease Control and Prevention (CDC) will implement
Pilgrim Software's automated platform for document control, complaints and corrective and preventive action (CAPA) systems management throughout the Laboratory Response Network (LRN) under the Division of Bioterrorism Preparedness & Response.
Pilgrim's SmartCAPA solution is a web-based, closed-loop system that allows users to investigate and resolve an issue and prevent recurrence. SmartCAPA will be integrated with the CDC’s internal LRN Website where complaints and product deviations are currently recorded. The complaints will then funnel into the SmartCAPA solution where they will automatically be routed through a closed-loop Investigation and CAPA process for follow-up and resolution.
The SmartDoc™ Solution helps organizations create, manage and share critical documents and best practices. SmartDoc will automate the review, approval and change management of controlled documents used throughout the LRN, and all current documents will be made available through the LRN Website.
“In selecting Pilgrim’s SmartSolve system, the LRN will elevate the harmonization and streamlining of processes that increase efficiency and enable quicker response to internal and external needs and expectations,” said Prashanth Rajendran, Pilgrim’s chief operating officer. “With the efficiencies it gains, the LRN will further solidify its reputation as a responsive division of the CDC.”
Posted on August 22, 2008 @ 07:56 am
Biogen Idec initiated a Phase III trial of intravenous (IV) Adentri (BG9928), an adenosine A1 receptor antagonist for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate Adentri — developed under a licensing agreement with CV Therapeutics — against placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the U.S.
The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) study is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV ADENTRI dosed as many as five days on body weight in ADHF patients with impaired renal function. Body weight is a measure of fluid accumulation, which is considered an important cause of symptoms experienced by heart failure patients.
“In previous clinical studies, ADENTRI has exhibited the potential to optimize fluid management without harmful effects on renal function. Heart failure patients with renal insufficiency are at risk for poor clinical outcomes and are among the most difficult to treat, as currently available therapies negatively impact renal function,” said lead investigator William Abraham, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.
Posted on August 21, 2008 @ 09:06 am
Boehringer Ingelheim has extended research funding for another year in its Alzheimer's disease collaboration with
Ablynx. In January 2007 the companies entered into a $265 million worldwide research and licensing agreement to discover and develop new therapies for Alzheimer's disease using Ablynx's Nanobodies, a class of therapeutic proteins. The agreement included a joint research program with Ablynx scientists.
BI will be responsible for the development, manufacture and commercialization of any products resulting from the collaboration. As part of the collaboration, Ablynx received an upfront fee and will receive development and commercial milestones as well as undisclosed royalties based on net sales.
Dr. Edwin Moses, chief executive officer and chairman of Ablynx, commented, "We are very pleased with the progress that has been made in our joint Alzheimer's disease program with BI. We look forward to continue working together with BI in this medical area which urgently requires an innovative approach."
Posted on August 21, 2008 @ 09:05 am
Bayer HealthCare Pharmaceuticals and
Onyx Pharmaceuticals began enrolling patients in the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial. The randomized, double-blind, placebo-controlled Phase III study is evaluating Nexavar (sorafenib) tablets as adjuvant treatment for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, M.D., vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life."
In addition, the FDA has completed a SPA for the STORM trial. An SPA is a written agreement on the design and size of a trial intended to form the basis for a new drug application.
The trial is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether oral Nexavar delays the time to recurrence and increases overall survival. The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.
Posted on August 21, 2008 @ 09:03 am
Lex Jansen has been appointed senior consultant, Clinical Data Strategies,
Octagon Research Solutions. In his new role, Mr. Jansen will serve as a consultant on Clinical Data Interchange Standard Consortium (CDISC) Study Data Tabulation Model (SDTM) implementations for pharma and biopharma organizations. Mr. Jansen will offer guidance on the use of data integration technologies and best practices to convert electronic clinical data into CDISC SDTM compliant format.
Mr. Jansen has nearly 20 years of professional experience in the pharmaceutical industry. Prior to joining Octagon, he was the senior director, Clinical Information Systems at TAKE Solutions where he consulted with clients to help them with their CDISC SDTM implementations and designed a SAS toolset to support SDTM implementations. He also spent 16 years at Organon where he was responsible for the global biometrics SAS infrastructure and served as technical lead for the CDISC Implementation Team, project lead and technical lead for Organon’s CDISC SDTM Late Stage Conversion Project and a core member of the SDTM-based data warehouse project. He is a member of the CDISC, Operational Data Model (ODM) team and a member of the editorial board of the journal, Pharmaceutical Programming.
Posted on August 20, 2008 @ 08:52 am
Bristol-Myers Squibb and
PDL BioPharma, Inc. entered an agreement for the global development and commercialization of PDL’s anti-CS1 antibody, elotuzumab, currently in Phase I development for multiple myeloma.
Elotuzumab offers a new approach to treating multiple myeloma in that it binds to the CS1 glycoprotein, allowing the immune system to selectively kill myeloma cells with minimal effects on other cell types. CS1 is a cell surface glycoprotein found on multiple myeloma cells but is minimally expressed on normal cells. Elotuzumab is currently being investigated in Phase I studies as a monotherapy and in combination with other therapies. There are currently no approved monoclonal antibodies on the market to treat multiple myeloma.
Under the terms of the collaboration, PDL will receive an upfront cash payment of $30 million for the development and marketing rights to the drug and for an option to expand the collaboration to include PDL241, another anti-CS1 antibody. PDL could receive additional payments of as much as $480 million in development milestones and as much as $200 million in sale-based milestones, in addition to royalties.
BMS will cover 80% of development costs and will lead global development activities, while PDL will complete the ongoing Phase I program and provide support for Phase II studies. The companies would share profits on sales of elozutumab in the U.S. PDL would receive royalties on sales outside the U.S.
If BMS opts to expand the collaboration to include PDL241, PDL would receive an additional payment of $15 million and could receive as much as $230 million in development milestones, and another $200 million in sales-based milestones. The same division of development costs would apply to that drug.
Posted on August 20, 2008 @ 08:51 am
Richard Ranieri has been appointed to the newly created position of executive vice president, Human Resources and Administration, and
Julio Casoy, M.D. has been appointed senior vice president, Medical Affairs, at
Sepracor.
Mr. Ranieri joins the company from Neurocrine Biosciences, where he was senior vice president and chief administrative officer. Mr. Ranieri managed and directed the company’s human resources function and its corporate communications, operations and purchasing. He also served as a corporate officer and was a member of the senior management team as well as secretary to the compensation committee of the board of directors. Prior to Neurocrine, he served as senior vice president, Human Resources at Genencor International for 12 years. Prior to joining Genencor, Mr. Ranieri spent more than 15 years with GlaxoSmithKline where he held a variety of human resources and sales management positions.
Dr. Casoy joins the company from Shire Pharmaceuticals where he served as senior vice president, Global Medical Affairs since 2005. Dr. Casoy was responsible for providing direction and oversight for all medical affairs activities supporting Shire’s drug development programs and marketed products worldwide. In addition, he was responsible for developing and directing objectives, policies and programs pertaining to global medical affairs activities and responsibilities and was a member of the R&D leadership team. Prior to Shire, he served as vice president of Global Medical Affairs, Compliance and intercontinental medical director at Wyeth.
“I am pleased to announce the addition of such accomplished professionals to Sepracor’s human resource and research and development teams,” said Adrian Adams, president and chief executive officer. “Richard brings with him a wealth of successful human resource, operational and general management experience, and his leadership skills will be integral to our plan and vision for continued organizational growth. Julio’s appointment to lead our medical affairs organization supports our focus on deepening and broadening our management team’s strength and capabilities and reinforces our objective of delivering enhanced performance and productivity across our commercial and research and development organizations.”
Posted on August 20, 2008 @ 06:31 am
United Drug plc, an Ireland-based distributor, wholesaler and contract packager, has acquired Allentown, PA-based
Sharp Corporation for $99 million. The acquisition is intended to complement UD's contract packaging operations in Europe with Sharp's U.S. presence.
Sharp will combine with UD’s existing U.S. operations to broaden its range of outsourced services for U.S. pharmaceutical and healthcare manufacturers. In contract packaging, which forms part of UD’s Supply Chain Services division, UD now combines the leading independent contract packaging business in the U.S. with UD’s existing European operations located in the UK, Belgium and Holland, according to a UD statement.
UD chief executive officer Liam FitzGerald commented, “We are delighted to announce the acquisition of Sharp. Sharp is a quality and compliance leader in pharmaceutical contract packaging in the U.S. and will fit extremely well with our existing packaging operations that provide services to the same client base in most major markets in Europe. The acquisition will also provide a major platform for our ongoing development as an international healthcare services company.”
The $99 million purchase price is equal to Sharp's reported 2007 revenues. Sharp employs 600 people, all of whom are expected to remain with the company after the acquisition.
Posted on August 19, 2008 @ 08:52 am
Peter C. Gonze has been appointed executive vice president of Global Business Development at
Averion International Corp. In this role, he will oversee the company’s global business development and marketing activities, and will serve on the company’s executive management team.
“Peter brings the necessary sales, marketing and operational management experience to grow Averion’s global sales. We will continue to pursue new business opportunities in North America and Europe, and plan to expand our geographic and therapeutic capabilities in emerging regions of the world,” said Dr. Markus H. Weissbach, chief executive officer of Averion International. “I welcome Peter to our senior management team and look to him to lead our sales growth and position Averion as a top-tier international CRO.”
Mr. Gonze has more than 35 years of pharmaceutical sales, marketing and development experience. He also has extensive leadership experience developing and commercializing products at biotech, pharmaceutical, device and consumer healthcare companies. Most recently, Mr. Gonze was the chief operating officer at Unither Pharmacueticals, a company focused on immunotherapeutic vaccines for oncology indications. He has broad experience in all aspects of commercial operations having held senior level positions in business development, commercial operations and general management with pharmaceutical and biotech companies including: GlaxoSmithKline, Rhône-Poulenc Rorer (now Sanofi-Aventis), Johnson & Johnson, Abbott Diagnostics-Medisense, and AltaRex.
Posted on August 19, 2008 @ 08:51 am
Cellumen, Inc., a discovery toxicology company, entered an agreement with
Mitsubishi Tanabe Pharma Corp. (MTPC), to develop panels of biomarkers that identify toxicity early in the drug development process.
“We’re pleased to announce this collaboration with MTPC,” says D. Lansing Taylor, Ph.D., chief executive of Cellumen. “By working together to develop biomarker panels, we hope to identify toxic liabilities much earlier in the drug development process than currently exists in the marketplace. Our ultimate goal is to enable MTPC to prioritize its lead drug series.”
Cellumen’s CellCiphr CSB Toxicity Profiling Services can identify toxic compounds in late primary screening through early preclinical phases, before entering expensive pre-clinical testing. By integrating optimal cells, panels of functional biomarkers and classifier software, CellCiphr is able to create a Safety Risk Index for compounds, and help researchers predict potential rodent or human toxicity earlier in the process.
Posted on August 19, 2008 @ 08:34 am
Nicholas J. Hart has joined
Emisphere Technologies, Inc. as vice president of strategy and development. In this capacity, Mr. Hart will be responsible for the planning and commercial development aspects of the company's Eligen technology.
Mr. Hart joins the company with more than 16 years of commercial experience in the pharmaceutical industry. Most recently, he was leader of the Contraception Therapy Area and a member of the corporate executive leadership team for Organon, recently acquired by Schering Plough. Also at Organon, he served as senior director/executive director of marketing of the Women's Healthcare Franchise; director of CNS marketing, and associate director of Specialty Products. Prior to Organon, Mr. Hart held various marketing and sales positions with Novartis, Sankyo Parke Davis Pharmaceuticals, and Bristol-Myers Squibb.
"I am delighted Nick Hart has joined our team at Emisphere to help us commercialize our Eligen Technology, including Eligen B12," said Michael V. Novinski, president and chief executive officer of Emisphere. "He brings a tremendous wealth of experience and a successful track record of accomplishment in the pharmaceutical industry. He has a demonstrated skill set both strategically and operationally, and I am confident that this track record will be continued at Emisphere."
Posted on August 18, 2008 @ 09:03 am
Lou Panini has b
Magazine
