Company and People Notes: Merck and Portola Sign Agreement; Eisai Appoints Senior Vice-Presidents; More ...

Company Notes

Biogen Idec (Cambridge, MA) and Acorda Therapeutics (Hawthorne, NY) entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is an oral sustained-release formulation of 4-aminopyridine intended to improve walking ability in people with MS. The parties also have entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International, a subsidiary of Elan (Monksland, Ireland).

Covidien’s (Loughlinstown, Dublin, Ireland) Mallinckrodt subsidiary voluntarily recalled lot #370-9004 of Mallinckrodt sodium chromate Cr-51 injection after routine postmarket testing found the product to be subpotent. The product is a radiopharmaceutical diagnostic agent used to determine red blood cell volume or mass, study red-blood-cell survival time, and evaluate blood loss. Covidien is in the process of recovering vials from customers in the United States, Canada, and Mexico. To date, the company has accounted for 81 of the 96 vials. No adverse events or complaints have been reported with this product.

Endo Pharmaceuticals (Chadds Ford, PA) licensed from Bioniche Life Sciences (Belleville, Ontario, Canada) the exclusive rights to develop and market Urocidin in the United States with an option for global rights. Urocidin is a patented formulation of mycobacterial cell wall-DNA complex developed by Bioniche to treat nonmuscle-invasive bladder cancer. Under the agreement, Endo will pay Bioniche an up-front cash payment of $20 million. In addition, Bioniche will manufacture the product and receive a transfer price for supply.

Through its subsidiary IMA Life, IMA (Bologna, Italy) acquired 51% of PharmaSiena (Siena, Italy), which designs and produces filling machines for ampuls and syringes in aseptic environments. The transaction is worth approximately EUR 1.3 million ($1.8 million). IMA Life also has the possibility of buying a further 19% of PharmaSiena during the next three years. The acquisition enables IMA to offer a range of solutions for liquid filling in aseptic environments.

Johnson & Johnson (New Brunswick, NJ) successfully completed its acquisition of Cougar Biotechnology (Los Angeles), a development-stage biopharmaceutical company with a focus on oncology. Johnson & Johnson obtained approximately 95.9% of Cougar Biotechnology’s outstanding common stock. The acquisition was completed without a vote or meeting of Cougar Biotechnology’s remaining shareholders. Cougar Biotechnology currently is conducting two Phase III trials for abiraterone acetate, a late stage, first-in-class compound for the treatment of prostate cancer.

Lonza (Basel) and Medarex (Princeton, NJ) signed an agreement that gives Medarex the option to work with Lonza to provide manufacturing services to support the development and commercialization of Medarex’s pipeline of therapeutic proteins and antibody drug conjugates. As part of the agreement, Lonza may provide process-development services for certain Medarex programs and may reserve manufacturing capacity for Medarex antibody and antibody drug conjugate programs at Lonza’s biopharmaceutical facilities.

Merck & Co (Whitehouse Station, NJ) and Portola Pharmaceuticals (South San Francisco, CA) signed an exclusive global collaboration and license agreement for the development and commercialization of betrixaban, an investigational oral Factor Xa inhibitor anticoagulant. Betrixaban is in Phase II clinical development for the prevention of stroke in patients with atrial fibrillation. Under the agreement, Merck will pay Portola an initial fee of $50 million, and Portola is eligible to receive additional cash payments of as much as $420 million upon achievement of certain milestones. Merck will assume all development and commercialization costs, including the costs of Phase III clinical trials. Portola has retained an option to cofund Phase III clinical trials in return for additional royalties and to copromote betrixaban with Merck in the United States.

Neugenesis (Burlingame, CA) is collaborating with PATH, an international nonprofit organization, to develop an influenza-vaccine production system. Under the agreement, Neugenesis will perform proof-of-concept work to demonstrate that the NeuBIOS protein-production platform can manufacture seasonal and pandemic influenza vaccine. The NeuBIOS platform is a proprietary method for rapid, high-level expression of recombinant, multivalent, influenza virus antigens from the transformed filamentous fungus Neurospora crassa.

Novartis (Basel) committed to a 10-year term of the strategic alliance with MorphoSys (Planegg, Germany), a developer of fully human antibodies, which was originally signed in December 2007. The decision followed MorphoSys’s achievement of predefined improvements in its proprietary technologies. The collaboration will last until 2017, and Novartis may extend it for an additional two years under the same financial terms and conditions. The option for Novartis to terminate the alliance after seven years is thus removed.

Novavax (Rockville, MD) and Cadila Pharmaceuticals (Bhat, Ahmedabad, India) launched a joint venture in India under an agreement the two companies signed in March 2009. The joint venture, called CPL Biologicals, will develop and manufacture vaccines, biological therapeutics, and diagnostics. CPL Biologicals also will establish manufacturing facilities in India and develop, produce, and sell products such as seasonal influenza vaccine and potentially novel vaccines against dengue fever and chikungunya fever. CPL Biologicals also expects to develop the pandemic H1N1 influenza vaccine candidate in India that Novavax is developing in the United States.

West Pharmaceutical Services (Lionville, PA) purchased the drug-delivery device business assets of Plastef Investissements (Osny, France). Under the agreement West gained the right to manufacture the eris safety syringe, a passive safety system for fixed- or staked-needle prefillable syringes. Operations will continue at Plastef’s production facility in Le Vaudreuil, France, which has approximately 75 employees.

Xanodyne Pharmaceuticals (Newport, KY) reached an agreement with the US Food and Drug Administration to keep the propoxyphene-containing products Darvon (propoxyphene hydrochloride), Darvon-N (propoxyphene napsylate), Darvocet-N 50, and Darvocet-N 100 (propoxyphene napsylate and acetaminophen) available as treatment options for the management of mild to moderate pain. This agreement follows a joint committee meeting with FDA’s Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committees that was held on Jan. 30, 2009.

Regulatory Roundup

The European Pharmacopoeia Commission, celebrates its 60th anniversary this year, announced progress toward international harmonization, as well as other ongoing activities, at its 134th session in France earlier this month. Among the achievements during the session, according to a press release from the European Directorate for the Quality of Medicines and Healthcare: the commission adopted 91 monographs and nine general chapters, including a chapter on dissolution testing and monographs on pramipexole dihydrochloride and Tiotropium bromide. With regard to harmonization, the commission collaborated with the US Pharmacopoeia and the Japanese Pharmacopoeia to sign off on six harmonized texts at the recent Pharmacopoeial Discussion Group in Yokohama; the European Commission approved all six texts during the session, according to the release. The commission also continued work on the seventh edition of the European Pharmacopoeia with the goal of grouping herbal drugs monographs and herbal drug preparations (including traditional Chinese medicines) in a separate chapter of the first volume. It was noted that future versions of Pharmeuropa may only be distributed electronically to allow draft monographs to be published at an earlier time and to improve the accessibility of the publication outside Europe.

The United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) intends to use an online reporting system to keep a close eye on the safety of swine-flu antiviral medicines Tamiflu (oseltamivir, Roche, Basel) and Relenza (zanamivir, GlaxoSmithKline, London) as their use increases, according to an MHRA press release “Like all medicines, the MHRA keeps the safety of these continually under review and we are keen to let people know there is a new way to tell us of any side effect suspicions,” said June Raine, director of vigilance and risk management of medicines at MHRA. The online system is based on MHRA’s Yellow Card Scheme, which the agency has been using for 40 years and makes completing a report quick and easy for the public as well as healthcare professionals. In the US, the Food and Drug Administration is encouraging citizens to report adverse events through its online MedWatch system.

FDA said on July 14 that it will now require manufacturers of some immunosuppressant drugs used in kidney (transplantation to update their labeling to reflect an increased risk of infections, according to a press release. The required label changes affect the following immunosuppressant drugs used to help prevent rejection of transplanted organs: Rapamune (sirolimus), Sandimmune (cyclosporine) and cyclosporine generic versions, Neoral (cyclosporine modified), and generics, Cellcept (mycophenolate mofetil) and generic versions, and Myfortic (mycophenolic acid). The changes are based on FDA’s review of reported adverse events.

FDA issued a new guidance for industry, Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketing Without an Approved Application, this week. The guidance provides information on the minimum data elements that should be included in a serious adverse event report, the label that should be in the report, reporting formats, and how to submit the reports.

People Notes

Abraxis BioScience (Los Angeles), an integrated, global biopharmaceutical company, appointed Mary Lynne Hedley executive vice-president of operations and chief scientific officer. Hedley most recently served as executive vice-president of Eisai North America (Woodcliff Lake, NJ) following Eisai’s acquisition of MGI Pharma (Bloomington, MN). Hedley joined MGI PHARMA in 2004 as senior vice-president and general manager.

Antares Pharma (Ewing, NJ) promoted Robert F. Apple to executive vice-president, chief financial officer, and president of the parenteral products division. The company also promoted Kaushik Dave to senior vice-president of product development and Peter Sadowski to senior vice-president of the parenteral products division.

Steven M. Michael, joined Covance (Princeton, NJ) as vice-president and chief scientific officer of global bioanalytical services. Michael will lead scientific, marketing, and business-development strategy for Covance’s bioanalytical services. He has 15 years of pharmaceutical industry experience, including bioanalytical research, translational research, and talent development.

Eisai (Woodcliff Lake, NJ) hired Steven C. Sembler as senior vice-president of oncology and institutional care. In this role, Sembler will be responsible for all aspects of the US commercial business for Eisai’s oncology and institutional-care therapeutic arenas. The company also hired Ann C. Miller as senior vice-president of its primary care and specialty business unit. Miller will oversee the commercial business of the unit and hold responsibility for more than $3 billion in sales and more than 700 employees. Sembler and Miller will work at Eisai’s Woodcliff Lake, New Jersey, facility.

Facet Biotech (Redwood City, CA) appointed Mark Rolfe as senior vice-president and chief scientific officer. Rolfe will be responsible for leading the company’s research efforts, including target validation, translational medicine, and protein-engineering technologies. He will join the company on August 20, 2009.

Xcellerex (Marlborough, MA) appointed Jonathan Lieber as its chief financial officer. Lieber joins Xcellerex from Altus Pharmaceuticals, where he was senior vice-president, chief financial officer, and treasurer. Lieber previously served as a vice-president in SG Cowen’s Healthcare Investment Banking Group.