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Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...
Hollywood, FL (July 24)-Azopharma Product Development Group added new equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler. The company has also added a Bausch & Strobel Aseptic Filling Isolator.
Zurich, Switzerland (Aug. 15)-Cytos Biotechnology entered into an agreement with Pfizer (New York) to research, develop, manufacture and commercialize novel vaccines for a defined number of human diseases. After the research programs are complete, Pfizer will acquire worldwide exclusive rights to commercialize certain vaccines, which are based on Cytos’s “Immunodrug” technology. Cytos retains its rights to develop, manufacture and commercialize vaccines against different disease targets in the same human diseases. Pfizer will be responsible for the vaccine development, manufacturing and commercialization. Cytos will receive CHF 10 million ($9.1 million) initially from Pfizer and is eligible to receive up to CHF 140 million ($127.5 million) in milestone payments and manufacturing technology transfer fees. Cytos is also eligible to receive research funding and royalties on net sales of products.
Parsippany, NJ (Aug. 12)-DSM Biologics and MorphoSys (Martinsried/Planegg, Germany) signed a biopharmaceutical manufacturing agreement that covers process development and CGMP manufacturing of Morphosys’s MOR202, which is a fully human “HuCAL” antibody, directed against CD38, a promising target for the treatment of multiple myeloma. DSM Biologics will manufacture MOR202 in its CGMP facilities in Groningen, The Netherlands. Financial details on this agreement were not disclosed.
Chennai, India (Aug. 13)-Orchid Chemicals & Pharmaceuticals will develop and manufacture an anticoagulant drug candidate that was initially discovered and developed through Phase I by Merck & Co. (Whitehouse Station, NJ). Orchid has invested in Diakron Pharmaceuticals (Morris Plains, NJ), a US-based drug discovery and development company that has an exclusive license agreement with Merck for the compound. Orchid’s investment in Diakron, through a combination of services and cash, will result in majority control for Orchid.
Basel, Switzerland (Aug. 15)-Roche sold four pharmaceutical products to Meda (Stockholm, Sweden), a specialty pharmaceutical company, including “Marcoumar” (phenprocoumon), “Torem” (torasemide), “Tilcotil” (tenoxicam) and “Aurorix” (moclobemide). The products are being transferred to Meda for 120 million Euros ($177 million). The transaction is expected to close in late 2008 and is subject to standard closing conditions.
Research Triangle Park, NC (Aug. 12)-Talecris Biotherapeutics, a biotechnology company, signed an agreement to be acquired by CSL (Parkville, Australia), a biotechnology company, for $3.1 billion in cash. This amount includes net debt, which as of June 30, 2008, was approximately $1.2 billion, implying an equity value as of that date of about $1.9 billion. The combined company will have a broad portfolio in the plasma-derived therapeutics industry.
Vancouver, Canada (Aug. 13)-Tekmira Pharmaceuticals will collaborate with Bristol-Myers Squibb (BMS, New York) using Tekmira’s “SNALP” (stable nucleic acid-lipid particles) technology to deliver small interfering RNAs (siRNAs) to specific organs and tissues outside of the liver. This work builds upon earlier programs in which BMS used siRNA delivery technology provided by Protiva Biotherapeutics. In May 2008, Protiva and Tekmira combined their businesses.
Munich, Germany (Aug. 13)-Wacker Chemie and RFS Pharma (Atlanta, GA) will collaborate on a proprietary synthesis pathway for the manufacture of RFS’s anti-HIV drug, “Amdoxovir,” a nucleoside analogue reverse transcriptase inhibitor. Wacker developed a patented manufacturing process that should lower production cost by creating a more efficient and scalable synthesis for Amdoxovir. Under the terms of the agreement, RFS will have exclusive rights to the new and improved process. Amdoxovir is currently in advanced Phase II clinical studies for the treatment of HIV-1 infections under a US investigational new drug application.
Corona, CA (Aug. 8)-Watson Pharmaceuticals, a specialty pharmaceutical company, announced that one lot of 75 mcg/hr fentanyl transdermal system patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 92461850, have expiration dates of August 31, 2009 and were manufactured by Watson Laboratories, Inc. Read the company’s announcement for more details.
Wilmington, NC (Aug 13)-AAIPharma appointed Ronald Kershner to lead the company’s North American biostatistics and data-management services groups. Kershner brings more than 25 years of industry experience and has been involved with regulatory submissions and FDA interactions, including more than 20 new drug application submissions.
Hubei, China (Aug. 18)-Benda Pharmaceutical appointed George Zhou as chief operating officer, effective August 13, 2008. Benda is a pharmaceutical company that produces “Gendicine,” a commercialized gene therapy medicine for the treatment of cancer, as well as traditional Chinese and conventional medicines.
Cedar Knolls, NJ (Aug. 19)-Emisphere Technologies, a biopharmaceutical company, appointed Nicholas J. Hart vice-president of strategy and development. Hart will be responsible for the planning and commercial development of the company’s “Eligen” drug-delivery technology.
Cambridge, MA (Aug. 19)-Helicos BioSciences, a company focused on genetic analysis technologies, appointed Steve Lombardi as the company’s chief executive officer, effective immediately. Lombardi succeeds Stan Lapidus, who will continue as chairman of the board of Helicos. Lombardi, who will retain the position of president, has served as president and chief operating officer of the company since October 2007.
Emeryville, CA (Aug. 18)-Peplin, a specialty pharmaceutical company, appointed Tom Wiggans chief executive officer, effective immediately. Wiggans will continue to serve as Peplin’s chairman of the board of directors. In addition, Eugene Bauer was appointed president and chief medical officer.
Gaithersburg, MD (Aug. 19)-VIRxSYS, a biotechnology company, named Shuyuan Zhang, PhD, as senior director of production. Zhang will focus on the development and late-stage GMP manufacture of lentiviral vectors and ex vivo patient CD4 T cell transduction and expansion for HIV treatment.