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Also, Sartorius Stedim Biotech GmbH to acquire Wave Biotech; AstraZeneca's John Patterson to retire; more...
Watertown, MA (Oct. 24)-The specialty pharmaceutical company Acusphere signed an agreement with Cephalon, a biopharmaceutical company, to provide $20 million in upfront financing by purchasing a $15-million senior secured convertible note and by paying a $5 million upfront fee for an exclusive license to "AI-525," a preclinical-stage injectable formulation of celecoxib using Acusphere’s proprietary hydrophobic drug delivery system technology. Celecoxib is the active ingredient in Pfizer's anti-inflammatory drug “Celebrex.” The transaction is expected to close in approximately 10 days.
Albany, NY (Oct. 29)-AMRI, a research and manufacturing services provider, announced the expansion of multipurpose pilot-plant facilities providing non-GMP manufacturing services up to a 1000 L scale located in Aurangabad, Maharashtra, India. The multipurpose plant increases AMRI’s ability to provide customized pilot-scale materials. The new facility will serve as an extension to AMRI’s kilo laboratory capabilities in Hyderabad, Andhra Pradesh, India, which operates to 100 L in scale.
London (Oct. 24)-The European Medicines Agency (EMEA) was alerted by Astellas Pharma Europe (Staines, England) that it will withdraw its marketing authorization application for "Vibativ" (telavancin) 15 mg/ml powder for concentrate for solution for infusion. Vibativ was expected to be used for the treatment of complicated skin and soft tissue infections in adults. In its official letter, the company stated that the withdrawal of Vibativ was based on the Committee for Medicinal Products for Human Use’s communication that the data provided were not sufficient to allow it to conclude a positive benefit-risk balance for Vibativ for the applied indication at that time.
London (Oct. 23)-The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorization for the obesity drug “Acomplia” (rimonabant) from Sanofi-Aventis. EMEA’s Committee for Medicinal Products for Human Use concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorization should be suspended across the European Union. Sanofi-Aventis released a statement saying it will comply with the European authorities' request to temporarily suspend the marketing authorization of Acomplia and will make every effort to actively support patients and health care professionals in this process. The company also said it is committed to provide additional evidence for the reevaluation of the risks and benefits of the drug through ongoing clinical studies.
Rockville, MD (Nov. 6)-The US Food and Drug Administration recently posted on its website a Sept. 23, 2008, warning letter to Pharmalucence (Bedford, MA) citing significant deviations from current good manufacturing practice (CGMP) regulations for manufacturing procedures at the company’s Bedford facility. Among the CGMP deviations listed by FDA in the letter are failure to prevent microbial contamination, failure of the quality-control unit to investigate the failure of a batch, failure to ensure drug-product containers are clean, and failure to ensure personnel wore protective apparel. FDA acknowledged receipt of Pharmalucence’s June 10, 2008, letter in response to the Form FDA-483, and the agency requested a written response to the Sept. 23, 2008 warning letter within 15 days.
London (Oct. 30)-GlaxoSmithKline (GSK) entered an agreement to acquire the biopharmaceutical company Genelabs Technologies (Redwood City, CA) for approximately $57 million through a tender offer of $1.30 per share in cash. The board of directors of Genelabs has unanimously recommended that shareholders tender their shares in the offer. GSK said in a press release that this acquisition will strengthen the company’s effort to develop novel therapies against the hepatitis C virus.
Noida, Uttar Pradesh, India (Oct. 29)-Jubilant Organosys announced that it has strategically aligned its two newly acquired entities, HollisterStier Laboratories (Spokane, WA) and DRAXIS Specialty Pharmaceuticals (Montreal) in order to consolidate the companies’ strengths into the two areas of contract manufacturing and specialty pharmaceuticals. Jubilant created new leadership roles for the chief executives of these new businesses. Jean Pierre Robert was appointed chief executive officer for the specialty pharmaceutical organization. He will be responsible for the radiopharmaceuticals business of DRAXIS as well as the allergy extracts business of Hollister-Stier Laboratories. Marcelo Morales was appointed chief executive officer for contract manufacturing, and will have responsibility of the sterile injectables manufacturing arm of HollisterStier and the sterile injectable, semisolids and solid-dose manufacturing operations of DRAXIS.
Princeton, NJ (Oct. 28)-Laureate Pharma, a biopharmaceutical development and protein production company, entered into a CGMP contract manufacturing agreement with Tolera Therapeutics (Kalamazoo, MI), a biotechnology company. According to the agreement, Laureate will produce Tolera’s TOL101 monoclonal antibody under CGMP conditions to be used in clinical trials. Terms of the manufacturing agreement were not disclosed.
New York (Oct. 30)-Pfizer's “NEWCON” facility in Illertissen, Germany, was named Overall Winner of the 2008 Facility of the Year Award (FOYA). The newly built NEWCON, which stands for NEW CONtainment, facility is a single-floor, single-containment module. The facility was named the winner in part because its production equipment is located in a dedicated processing module and is mostly automated to ensure that no dust from the highly potent varenicline (“Chantix” and “Champix”) can escape from the manufacturing area. For the first time, dust-free production and fully automated production of film-coated tablets was made possible. All of the process stages are controlled and monitored from a separate control room so that employees do not come into contact with dust that might be generated during the tablet production run. The International Society for Pharmaceutical Engineering and Interphex were among the sponsors of the FOYA award.
Goettingen, Germany (Oct. 31)-Sartorius Stedim Biotech GmbH, a subsidiary of the biotechnology supplier Sartorius Stedim Biotech, will acquire the equipment supplier Wave Biotech (Tagelswangen, Switzerland). In addition to their joint research projects, Sartorius has been exclusively marketing Wave's product range, which covers various types of single-use bioreactors and further equipment for biopharmaceutical research and manufacture. The acquisition, which is subject to customary regulatory approval, is expected to be completed in December 2008. Financial terms were not disclosed.
Albany, NY (Oct. 27)-The research and manufacturing services provider AMRI named Nicholas Moore, PhD, director of development and pharmacology in discovery research and development. Moore will report to Bruce Sargent, PhD, vice-president of discovery research and development.
London (Nov. 4)-AstraZeneca announced that John Patterson, executive director of development, will retire from the company in March 2009, and will retire from the board of AstraZeneca on March 31, 2009. Anders Ekblom is appointed to the role of Executive Vice President, Development, effective January 1, 2009. He is currently vice-president and head of global clinical development at AstraZeneca.
Paris (Oct. 4)-Arterial Remodeling Technologies (ART), a company focused on developing bioresorbable peripheral and coronary polymer stents, appointed Machiel Van Der Leest chief executive officer, effective immediately. Van Der Leest has been ART’s chief operating officer since March 2008.
Vancouver, Canada (Oct. 31)-Pacgen Biopharmaceuticals appointed Chung Yu Wang, current chairman and director, as interim president and chief executive officer. Pacgen also appointed Kevin McGarry, current director, as lead independent director of the board. These appointments follow the previously announced departure of Duffy DuFresne as president, CEO, and member of the board of directors.
Lysaker, Norway (Nov. 4)-Pronova BioPharma, a pharmaceutical company focused on the research, development and manufacture of marine-originated omega-3 derived products, appointed Per-Oluf Olsen as chief executive officer, effective Nov. 17, 2008. Olsen will succeed Tomas Settevik, who has informed the board that he wishes to stand down from his position as CEO.
St. Louis (Oct. 30)-Sigma-Aldrich appointed Rakesh Sachdev as vice-president and chief financial officer, effective Nov. 17, 2008. He succeeds Sigma-Aldrich's CFO Mike Hogan, who announced earlier this year his plans to retire. In addition, Sigma-Aldrich announced the following appointments, which will be effective Jan. 1, 2009: Karen Miller was promoted to the newly created position of vice-president of strategy and corporate development; Kevin Krosley was promoted to vice-president of new ventures group; Dave Julien was appointed president of supply chain; Frank Wicks was appointed president of research specialties and research essentials.
Bradenton, FL (Oct. 28)-WellSpring Pharmaceutical, a privately held pharmaceutical company, named Wendy Shusko chief operating officer. Shusko previously held the position of chief financial officer, having joined the company in early 2000.