Bristol-Myers Squibb and Matrix Laboratories Limited, a Mylan subsidiary, have agreed to expand access to Reyataz (atazanavir sulfate) for the treatment of HIV. This immunity-from-suit agreement enables Matrix to manufacture and sell atazanavir, stavudine, and didanosine, in sub-Saharan Africa and India.
Gilead Sciences and the specialty pharmaceutical company Tibotec Pharmaceuticals have agreed to develop and commercialize a new fixed-dose antiretroviral combination product containing Gilead's cobicistat and Tibotec's protease inhibitor Prezista (darunavir). Cobicistat is an investigational pharmacoenhancing agent that increases blood levels of certain HIV medicines to enable once-daily dosing. Prezista is indicated in the United States for the treatment of HIV-infected individuals and is coadministered with ritonavir in combination with other antiretroviral agents. Under the terms of the agreement, Tibotec will be responsible for the formulation, manufacturing, registration, distribution, and commercialization of the cobicistat and Prezista fixed-dose combination worldwide. Gilead retains sole rights for the manufacture, development, and commercialization of cobicistat as a stand-alone product and for use in combination with other agents. The deal is subject to customary closing conditions and regulatory approval.
Merck KGaA has announced that the European Commission has granted an approval for three prefilled, ready-to-use pen injectors for fertility treatment. This group of pens is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f (follitropin alfa) 300 IU, 450 IU, and 900 IU, Luveris (lutropin alfa) 450 IU, and Ovidrel/Ovitrelle 250 micrograms (choriogonadotropin alfa).
Pfizer and the Russian pharmaceutical investment and research and development (R&D) group ChemRar High Tech Center have signed a Memorandum of Understanding (MoU) to explore a collaboration focused on the research, development, and commercialization of drugs in Russia and other countries. Under the terms of the MoU, the companies can further collaborate with other potential partners, including the Moscow Institute of Physics and Technology, the Skolkovo Foundation and other members of the Russian Biopharmaceutical Cluster "Northern," created under the Federal Target Program of the Ministry of Industry and Trade of the Russian Federation. In addition, the companies can establish a shared-risk platform for several Pfizer R&D programs designed to achieve clinical candidates and proof of concept in the clinic.
Sanofi has entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives for the treatment of tuberculosis. Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Dr. Carl Nathan's laboratory at Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis. Weill Cornell has secured funding for the screening activities conducted by Nathan's team from the Bill & Melinda Gates Foundation. Sanofi and Weill Cornell will jointly determine if any compounds screened through the collaboration should be brought forward for optimization and potential development.
Michael A. Schulz was appointed as a member of the board of management of Bayer CropScience effective June 1, 2011, and as the company's head of business planning and administration effective July 1, 2011. He succeeds Dirk Suwelack, who will retire at the end of 2011.
The contract reseach organization INC Research has appointed Chris Smyth to its oncology leadership team as senior vice-president of clinical development. Smith has more than 20 years of R&D experience in the pharmaceutical industry. Prior to joining INC Research, he spent eight years at a biopharmaceutical company specializing in the development of small molecules, biologicals, and DNA aptamers for the treatment of cancer.
Tengion, a clinical-stage biotechnology company, has announced the resignation of Steven A. Nichtberger from his role as president, CEO, and member of the company's board of directors. David I. Scheer, Tengion's current chairman of the board, will assume an interim leadership role while an external search is conducted for a new CEO.