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Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...
Alnylam Pharmaceuticals (Cambridge, MA), an RNAi therapeutics company, and the biopharmaceutical company Tekmira Pharmaceuticals (Vancouver, Canada) formed a two-year research collaboration focused on the discovery of novel cationic lipids and lipid nanoparticles for the systemic delivery of RNAi therapeutics. Under the agreement, Alnylam will receive exclusive rights to all new inventions as well as rights to sublicense any resulting intellectual property to Alnylam’s current and future partners. Tekmira receives rights to use new inventions for its own RNAi therapeutic programs licensed under Alnylam intellectual property through its InterfeRx program.
Dendreon (Seattle, WA) signed a lease agreement to build a 160,000-ft2 manufacturing facility in Union City, Georgia, where it expects to manufacture its prostate cancer drug Provenge (sipuleucel-T). Pending FDA approval, Dendreon will launch Provenge from its existing facility in Morris Plains, New Jersey, and increase manufacturing capacity at its other facilities under development in Union City, Georgia, and Seal Beach, California.
DSM Pharmaceutical Products (Parsippany, NJ) announced that its Greenville, North Carolina, facility received the Potent Compound Safety Certification from SafeBridge Consultants. The certification is for competency and proficiency in the safe handling of potent active pharmaceutical ingredients and drug products, and applies to the site’s potent sterile fill–finish production area, including the high-containment fill–finish facility, and the associated quality-control laboratories.
Elan (Dublin, Ireland) announced in a press release that it filed suit against Biogen Idec (Cambridge, MA) in federal court in New York seeking declaratory and injunctive relief that certain aspects of Elan’s recently announced transaction with affiliates of Johnson & Johnson (New Brunswick NJ) comply with Elan’s collaboration agreement with Biogen Idec for the development and marketing of Tysabri (natalizumab). In a letter to Elan dated July 28, 2009, Biogen Idec alleged that Elan was in material breach of the collaboration agreement, and Elan believes it is in compliance of the agreement.
Genzyme (Cambridge, MA) reported supply problems with Cerezyme (imiglucerase for injection). The company decided to discard 80% of remaining work-in-process Cerezyme material that was unfinished when the company temporarily shut down its Allston, Massachusetts, facility. This decision was made to minimize risk to the Allston plant and ensure that new supply will be available by the end of this year, according to a company press release.
Lonza (Basel, Switzerland) started up the second phase of its large-scale active pharmaceutical ingredient facility in Nansha, China. The Nansha site contains facilities for administration, research and development, a kilo laboratory, and both small-scale and large-scale production. Seventy scientists provide research and development services in a 1000-m2 laboratory area.
Millipore (Billerica, MA), a provider of technologies, tools and services, acquired BioAnaLab (Oxford, UK) a provider of biologic drugs and vaccines analysis. The deal allows Millipore to expand its biopharmaceutical services business in Europe.
Nabi Biopharmaceuticals (Rockville, MD) agreed to sell its staph vaccine candidate PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GlaxoSmithKline (GSK, London) for $46 million. Nabi will receive an initial cash payment of $20 million plus up to $26 million in milestone payments. Nabi anticipates closing the sale before year-end 2009 and completing the milestones within the next 18 months, according to a press release.
Nycomed (Zurich, Switzerland) agreed to purchase 20 branded generic products from sanofi aventis (Paris) and Zentiva (Prague) in several Central and Eastern European countries. The deal received approval from the European Commission and the Czech Antimonopoly Office, and the company expects it to be closed in September 2009. In a separate announcement, Nycomed said it entered into a development, manufacturing, and commercialization agreement with Forest Laboratories (New York) in the United States for Daxas (roflumilast), a once-daily oral treatment for symptomatic chronic obstructive pulmonary disease (COPD). Nycomed will retain marketing rights to Daxas in Europe and the rest of the world.
Patheon (Research Triangle Park, NC), a provider of drug-development and manufacturing services, announced that its Manati, Puerto Rico, solid-dose manufacturing facility received regulatory approval from the European Medicines Agency following a successful inspection in May by the Medical Products Agency of Sweden.
Opexa Therapeutics (The Woodlands, TX), a company developing a novel T-cell immunotherapy for multiple sclerosis, entered into stem-cell development agreement with Novartis (Basel, Switzerland) for up to $50 million plus royalties. Novartis will acquire the stem-cell technology from Opexa, and Novartis will have full responsibility for funding and carrying out all research, development, and commercialization. Opexa will receive an initial cash payment of $3 million, an additional $1 million as a technology-transfer fee, and milestone payments.
Xcelience (Tampa, FL), a provider of early-phase drug-development services, will expand and increase headcount in its formulation development and quality assurance departments.
Advanced Cell Technology (Worcester, MA) appointed Edmund Mickunas vice-president of regulatory. Prior to joining Advanced Cell, Mickunas was executive director of regulatory affairs and quality assurance for Applied Genetic Technologies (Alachua, FL).
BioTime (Alameda, CA) appointed Walter Funk vice-president of stem-cell research. Funk will manage BioTime’s team of scientists developing numerous products from human embryonic stem cells for use in research and therapies.
Cardinal Health (Dublin, OH) elected George Barrett to the company’s board of directors and named him chairman and CEO of Cardinal Health, effective on the completion of the planned spinoff of CareFusion Corp. on Aug. 31. Barrett has been vice-chairman and CEO of the company’s Healthcare Supply Chain Services segment since joining Cardinal Health in January 2008. He replaces R. Kerry Clark, who previously announced that he would retire from the company upon completion of the CareFusion spinoff.
Dynavax Technologies (Berkeley, CA), a biopharmaceutical company, announced that Deborah A. Smeltzer, vice-president of operations and chief financial officer, is planning to retire by year-end. The company also announced the promotion of Jennifer Lew from controller and principal accounting officer to vice-president of finance.
Egen (Huntsville, AL), a biopharmaceutical company specializing in nucleic acid therapeutics and delivery, promoted Jason Fewell from director of biology and pharmacology to vice-president of preclinical research and development.
Novo Nordisk (Princeton, NJ), a healthcare company focusing on diabetes care, appointed Per Falk vice-president of clinical, medical, and regulatory affairs for North America. Falk joins the US executive team and will report directly to Jerzy Gruhn, president of Novo Nordisk Inc., the Novo Nordisk US affiliate, and senior vice-president for Novo Nordisk A/S, North America.