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Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...
On Apr. 17, 2009, Actavis (Morristown, NJ) announced the reintroduction by its Actavis Totowa subsidiary of oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis’ Little Falls, New Jersey, facility following a recently completed FDA inspection. In December 2008, Actavis reached agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company’s Actavis Totowa subsidiary and operations at three facilities: two in Totowa, New Jersey and one in Little Falls, New Jersey.
Biogen Idec (Cambridge, MA) announced that the US Food and Drug Administration approved the company's high-titer process for the production of its multiple sclerosis drug Tysabri (natalizumab). Biogen Idec received similar approval from the European Medicines Agency for the high titer process in December 2008. The new, higher-yield process will be used to manufacture Tysabri at the company's plant in Research Triangle Park, North Carolina.
Chiltern International (London), a clinical research organization (CRO) providing services in Europe, the Americas and India, announced the acquisition of Vigiun, a CRO located in Sao Paulo, Brazil. Vigiun’s founders, Eduardo Forleo and Elisa Halker, will remain with the company. Forleo was appointed Chiltern's country manager for Brazil and medical director for Latin America, and Halker will serve as director of clinical operations for Brazil.
Galapagos (Mechelen, Belgium), a drug discovery and development company, entered into a multiyear alliance with Merck & Co. (Whitehouse Station, NJ) through an affiliate, to develop potential new therapies in inflammatory diseases. Galapagos will be responsible for the discovery and preclinical development of new small molecule candidates. Merck will have the exclusive option to license each candidate for clinical development and commercialization on a worldwide basis. Merck will be responsible for the development and commercialization of the candidate drug. Under the terms of the agreement, Galapagos will receive an upfront fee of EUR 2.5 million ($3.3 million) from Merck. In addition, Galapagos is eligible to receive milestone payments that could potentially exceed EUR 192 million ($249.7 million) total for multiple products, as well as milestones and royalties upon commercialization of any products.
GlaxoSmithKline (GSK, London) and the dermatology company Stiefel Laboratories (Coral Gables, Florida) signed an agreement to create a specialist dermatology business. Under the terms of the agreement, GSK will acquire Stiefel for $2.9 billion in cash. GSK also expects to assume $0.4 billion of net debt upon closing. A potential further $0.3 billion cash payment is contingent on future performance. GSK's existing prescription dermatological products will be combined with Stiefel's, and the new specialist global business will operate under the Stiefel identity within the GSK Group.
Hovione (Loures, Portugal) announced that its licensee, Daiichi Sankyo (Tokyo), intends to use Hovione’s TwinCaps dry-powder inhaler device in the launch of the compound CS-8958, an inhaled long-acting neuraminidase inhibitor active against the influenza virus. Daiichi Sankyo has completed patient enrollment for Phase III clinical trials in Japan and other Asian countries, and results are expected to be released mid year, including data to confirm the device switching. TwinCaps was specifically developed by Hovione for the indication and licensed to Daiichi Sankyo and Biota Holdings (Victoria, Australia).
Patheon (Research Triange Park, NC), a provider of drug-development and manufacturing services, expanded its Toronto manufacturing facility. The expansion adds 10,000 ft2 of good-manufacturing-practice-compliant space dedicated to the production of oral contraceptives and includes full-scale commercial production capabilities, including dispensing, granulation, compression, film coating, and primary packaging.
Sanofi-aventis (Paris) agreed to acquire BiPar Sciences (Brisbane, CA), a privately held biopharmaceutical company focused on the emerging field of DNA repair using PARP (poly ADP-ribose polymerase) inhibitors. By preventing cancer cells from repairing their own DNA, PARP inhibitors ultimately cause cancer cell death. BiPar’s lead product candidate is BSI-201, a potential PARP inhibitor currently being studied in Phase II clinical trials in metastatic triple negative breast cancer, ovarian cancer and other malignancies. Under the agreement, the purchase price will depend on the achievement of milestone payments related to the development of BSI-201, which could achieve a maximum of $500 million. The closing of the transaction is expected to occur in the second quarter of 2009, subject to customary regulatory clearance.
The US Food and Drug Administration recently posted a Warning Letter on its website issued to a Chinese manufacturer of heparin sodium USP. The letter cites Shanghai No. 1 Biochemical & Pharmaceutical (Shanghai, China) for “significant deviations” from current good manufacturing practices and also states that FDA believes the drugmaker made untrue statements relating to the manufacture of heparin. The letter states that the company did not manufacture heparin at the site that was inspected, rather, that it subcontracted the manufacturing and testing of the heparin to two other facilities. FDA says the heparin was received by Shanghai No. 1 and then repackaged and relabled.
Sue Mahony, general manager of Eli Lilly's Canadian affiliate, will join Lilly's senior management team as the new senior vice-president of human resources, effective May 1, 2009. She succeeds Tony Murphy, who announced his retirement last month.
George Bobotas joined the specialty pharmaceutical company Halo Pharmaceutical (Whippany, NJ) as chief scientific officer. His appointment comes as part of a research and development partnership between Halo Pharmaceutical and DeMelleBioPharma. Halo and DeMelle are working closely together in this alliance on the development of several client products.
Minster Pharmaceuticals (Saffron Walden, UK), a drug-development company specializing in neurological and psychiatric disorders, appointed Karl Keegan chief financial officer and a member of the company’s board. Keegan succeeds Robert Aubrey as CFO. Aubrey will continue as an executive director of the company.
Proteolix (South San Francisco, CA), a biopharmaceutical company, appointed Michael G. Kauffman chief medical officer. Kauffman, previously a member of Proteolix's board of directors, was a clinical developer at Millennium Pharmaceuticals, now a subsidiary of Takeda Pharmaceutical (Tokyo). Proteolix also appointed Albert L. Kraus vice-president of regulatory affairs and quality assurance. Kraus joins Proteolix with more than 20 years of pharmaceutical-industry experience in overseeing drug development and regulatory strategy, particularly for novel oncology products.
Resolvyx Pharmaceuticals (Bedford, MA), a biopharmaceutical company, appointed Philip J. Vickers chief scientific officer and as a member of the board of directors. Before joining Resolvyx, Vickers was senior vice-president and head of US research for Boehringer-Ingelheim (Ingelheim, Germany).
Roche (Basel) announced several organizational changes related to the completion of the Genentech (South San Francisco, CA) transaction. Arthur D. Levinson, currently Genentech chairman and CEO, will chair Genentech’s new board of directors and steer the integration of Genentech and Roche. Pascal Soriot will be appointed CEO of Genentech. He will lead all activities in the United States and report directly to Group CEO Severin Schwan. For more details on other personnel changes as a result of the integration of the two companies, see the company press release.