Facility of the Year Awards Announced; Eisai Completes Acquisition Of AkaRx; And More.
Biogen Idec (Cambridge, MA), Genentech (South San Francisco, CA), MannKind Corp. (Valencia, CA) Pfizer Biotechnology Ireland (County Cork), and Pfizer Ireland Pharmaceuticals (Dublin) were winners of the Facility of the Year Awards. The awards, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, recognize state-of-the art pharmaceutical manufacturing projects. Biogen Idec won the Operational Excellence award for its facility in Research Triangle Park, NC; Genentech won the Project Execution Award for its facility in Singapore; MannKind won the Equipment Innovation Award for its facility in Connecticut; Pfizer Biotechnology Ireland won the Sustainability Award; and Pfizer Ireland Pharmaceuticals won the Facility Integration Award.
Eisai (Woodcliff Lake, NJ) has completed its acquisition of biopharmaceutical company AkaRx (Bridgewater, NJ) for $255 million. AkaRx is now a wholly owned subsidiary of Eisai and Eisai has the exclusive worldwide rights to develop, market, and manufacture AKR-501, an investigational thrombopoietin receptor agonist that increases platelet production.
Elusys Therapeutics (Pine Brook, NJ), a privately held biopharmaceutical company, has received a federal contract potentially worth $143 million to develop, manufacture, and license Anthim, a late-stage anthrax drug. Under terms of the contract from the federal Biomedical Advanced Research and Development Authority, $16.8 million will be provided in the first year with options for additional money for the following four years.
Genentech (South San Francisco, CA) has received US Food and Drug Administration approval for ACTEMRA (tocilizumab) for the treatment of adult patients with moderately to severely-active rheumatoid arthritis (RA). ACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA.
inVentiv Health (Somerset, NJ), has acquired ParagonRx (Wilmington, DE), a consulting company that specializes in pharmaceutical risk management. The acquisition was completed in late December and will make inVentiv a leading provider of risk evaluation & mitigation strategies. ParagonRx will be part of the inVentiv clinical division.
KaloBios Pharmaceuticals (South San Francisco, CA) has reached an agreement with Sanofi Pasteur (Paris) to develop KB001, an investigational new biologic for the treatment of Pseudomonas aeruginosa infections. KaloBios will get $35 million from Sanofi Pasteur, plus funds for development, regulatory, and commercialization potentially reaching $255 million or more. Sanofi Pasteur retains the option to acquire the commercial rights to KaloBios' indications for KB001 outside the US and co-promotion rights in the US.
Laureate Pharma (Princeton, NJ) and Iconic Therapeutics (Atlanta, GA) have completed the first lot of hI-con1 recombinant Fc-Factor VII fusion protein, a treatment for adult macular degeneration. hI-con1 is a recombinant protein that attacks and destroys pathological blood vessels with no effect on normal blood vessels.
Lundbeck (Copenhagen, Denmark), which developed the anti-depressant drug citalopram, is being investigated by the European Commission for possible antitrust violations. Formal proceedings have begun to determine if Lundbeck breached EU rules by making it more difficult for generic citalopram to enter European markets.
MannKind Corp. (Valencia, CA) has been informed by FDA that the agency’s review of the company’s new drug application for its ultra rapid-acting insulin therapy has been delayed. Initially, MannKind had an action date of Jan. 16, 2010. However, FDA has not yet completed inspection of the insulin-manufacturing facilities of a third-party supplier to MannKind.
Patheon (Toronto) has signed two five-year contracts with sanofi aventis (Paris) extending the manufacturing partnership between the two companies. The agreements cover products that are manufactured in Patheon’s Swindon, United Kingdom and Bourgoin, France facilities.
PerkinElmer’s (Waltham, MA) OneSource has reached an agreement with VWR International (West Chester, PA) on a joint-service pact. The collaboration will provide multi-vendor maintenance and qualification services of laboratory equipment ranging from pipettes and pH meters to analytical instrumentation.
Pfizer (New York) and Strides Arcolab (Bangalore, India) have formed a collaboration through which Pfizer will offer off-patent sterile injectable and oral products in the US through its Established Products Business Unit. The collaboration is expected to produce 40 off-patent products to healthcare providers and patients in the US, with the first offered this year.
Biogen Idec (Cambridge, MA) has named Francesco Granata executive vice-president of global commercial operations; Tony Kingsley senior vice-president of US commercial Operations; and Frederick Munschauer vice-president of US medical affairs.
Nektar Therapeutics (San Carlos, CA) has appointed Stephen K. Doberstein senior vice-president and chief scientific officer. Doberstein, who has over 17 years of experience in biotechnology research and development, will oversee Nektar's discovery research.
Genzyme (Cambridge, MA) has hired Ron Branning as its senior vice-president of global product quality. In his new position, Branning is responsible for quality control of Genzyme products made at 17 sites worldwide. Previously, Branning was vice-president of quality and compliance and chief compliance officer at Gilead Sciences (Foster City, CA).