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Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...
Marcy l'Etoile, France (Dec. 8)-bioMérieux, a company focused on in vitro diagnostics, acquired PML Microbiologicals (Wilsonville, OR), a privately held in vitro diagnostics company that has manufacturing and marketing teams based in Portland, Oregon, and Toronto, Canada. bioMérieux purchased PML Microbiologicals for $30 million.
Princeton, NJ and London (Dec. 8)-Bristol-Myers Squibb and AstraZeneca expanded their January 2007 collaboration to develop and commercialize dapagliflozin to include 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 to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.
South San Francisco, CA and Osaka, Japan (Dec. 3)-Cell Genesys and Takeda Pharmaceutical, together with its wholly owned subsidiary Millennium: The Takeda Oncology Company, have mutually agreed to suspend the further development of “GVAX” immunotherapy for prostate cancer. Also, Takeda has ended the collaboration agreement with Cell Genesys for the development and commercialization of the product. Under the terms of the agreement, Takeda will return all commercial rights to GVAX to Cell Genesys and make certain payments relating to the phasing out of the remaining clinical development activities.
San Diego, CA (Dec. 8)-Halozyme Therapeutics, a biopharmaceutical company, announced that Roche (Basel, Switzerland) has dosed the first patient in a Phase I clinical trial with a subcutaneous formulation using “Enhanze” Technology of a biologic directed to a Roche exclusive target, triggering a milestone payment of $10.25 million to Halozyme. Halozyme entered into a supply agreement with Roche to provide its hyaluronidase enzyme, rHuPH20, for use in formulations with biologics directed against Roche targets covered under the licensing and collaboration agreement. Halozyme continues to scale up its manufacturing processes to enhance yields and efficiencies in order to produce multikilogram quantities of enzyme. As specified in the agreement, Halozyme will supply rHuPH20 to Roche to fulfill all of its clinical development and commercialization requirements.
Sophia Antipolis, France (Dec. 2)-The biopharmaceutical company NicOx signed an agreement with DSM (Heerlen, The Netherlands) for the commercial manufacture and supply of naproxcinod drug substance. Naproxcinod is NicOx’s lead investigational product and the first compound in the cyclooxygenase-inhibiting nitric oxide-donating (CINOD) class of anti-inflammatory agents, currently in Phase III trials. Under the terms of the agreement, DSM will supply the naproxcinod active pharmaceutical ingredient for commercial purposes from its fine chemicals production site in Linz, Austria.
Rockville, MD (Dec. 3)-The US Food and Drug Administration announced a recall of 6.37 million bottles of Sandoz’s (Princeton, NJ) generic metoprolol succinate extended-release (XL) tablets due to inadequate documentation and in-process controls. All lots with expiry dates through August 2010 are being recalled, including 25- and 50-mg doses in 100- and 1,000-count bottles, and 100- and 200-mg doses in 100-count bottles.
Rockville, MD (Dec. 2)-The US Pharmacopeial (USP) Convention is seeking public comment on an informational general chapter aimed at promoting safe medication use through recommendations for medication working environments. General Chapter <1066> “Physical Environments That Promote Safe Medication Use” offers guidance on routine tasks associated with medication use such as procurement, prescribing, transcribing, order entry, preparation, dispensing and the administration of medications. Key recommendations for health professionals in the chapter include designating “medication safety zones,” preventing interruptions and distractions, reducing clutter, maintaining proper lighting, and more. Comments may be submitted here on USP’s website until Feb. 15, 2009.
Lake Success, NY (Dec. 9)-Aceto, a company focused on sourcing, quality assurance, regulatory support, marketing, and distribution of chemically derived pharmaceuticals, biopharmaceuticals, specialty chemicals and crop protection products, announced two promotions. Effective January 1, 2009, Vincent Miata, senior vice-president responsible for the company's chemicals and colorants business, was promoted to President. Frank DeBenedittis, senior vice-president of the company's health sciences business, was promoted to executive vice-president and will also assume the role of the newly created position of director of global pharmaceutical strategy.
Sunnyvale, CA (Dec. 5)-Dionex, a manufacturer and marketer of chromatography systems for chemical analysis, announced that Lukas Braunschweiler will resign as president and chief executive officer, effective May 31, 2009. Braunschweiler resigned in order to accept a new position as CEO of Ruag Holding (Bern, Switzerland), an aviation, defense, and technology company.
St. Louis, MO (Dec. 5)-KV Pharmaceutical Company announced that the board of directors has terminated, for cause, the employment agreement of the company’s chairman and chief executive officer, Marc Hermelin, effective immediately. Hermelin informed the company, however, that he believes he effectively retired from his position prior to the board’s action. He is expected to remain a member of the board of directors. David Van Vliet, president of the company’s ETHEX subsidiary, was appointed interim CEO. Terry B. Hatfield was named chairman of the board of directors.
San Diego, CA (Dec. 4)-NovaRx, a biopharmaceutical company, appointed Norrie J.W. Russell president and chief operating officer. Russell brings more than 25 years experience to the company and has previously held positions at Kalos Therapeutics (San Diego, CA) and Invitrogen (Carlsbad, CA).
San Diego, CA (Dec. 5)-Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of obesity, announced changes to its management team. Gary Tollefson has resigned as director, president, and CEO as of December 4, 2008. Orexigen has retained an executive search firm to assist it in finding a new CEO. In addition, Anthony McKinney, the company's chief business officer, and Frank Bymaster, the company's vice-president of neuroscience, will leave the company effective immediately. Michael Cowley, the company's chief scientific officer, will be step down from this position but will serve as a consultant to the company. Orexigen also announced that 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) will be discontinued effective immediately.
Omaha, NE (Dec. 3)-Qualia Clinical Services, a contract research organization, appointed Choo Pin Por to lead the company’s data management and regulatory affairs departments. Por previously held several positions at Novapharm (Scarborough, Ontario, Canada).
Basel (Dec. 8)-Jonathan Knowles, head of group research and member of the corporate executive committee of Roche, will retire from Roche at the end of 2009. During 2009, he will transfer his responsibilities to Lee Babiss, head of pharma research, and Jean-Jacques Garaud, head of pharma development. Knowles remains a member of the Roche executive committee, the pharma strategic portfolio committee and a member of the Genentech and Chugai boards.