Abbott Laboratories (Abbott Park, IL) announced a definitive agreement to acquire biopharmaceutical company Facet Biotech (Redwood City, CA). Abbott will pay $27 per share or approximately $450 million. Abbott said in a press release that the acquisition would enhance its pharmaceutical pipeline.
The US Food and Drug Administration issued a complete response letter regarding the New Drug Application for Bydureon, an investigational, extended-release medication for type 2 diabetes being developed by Eli Lily (Indianapolis, IN), biopharmaceutical company Amylin Pharmaceuticals (San Diego, CA), and biotechnology company Alkermes (Waltham, MA). The letter did not contain requests for new preclinical or clinical trials. It did include requests relating to the finalization of the product labeling with an accompanying risk evaluation and mitigation strategy and clarification of existing manufacturing processes.
FDA issued a new black-box warning for Plavix, the anticlotting medicine from Bristol-Myers Squibb (New York) and sanofi-aventis (Paris). The warning concerns the diminished effectiveness of Plavix in patients who have a genetic variation leading to reduced formation of the active metabolite.
Contract manufacturer Draxis Pharma (Montreal) successfully completed an FDA current good manufacturing practice review of both sterile parenteral and nonsterile semisolid manufacturing capabilities and a preapproval inspection for three client products.
Eli Lilly (Indianapolis, IN) and biotechnology company Acrux (Melbourne, Australia) agreed to an exclusive licensing deal for Acrux’s experimental underarm testosterone solution, which is under review by FDA for the treatment of testosterone deficiency in men. Acrux will get an upfront payment of $50 million plus $3 million on the transfer of manufacturing assets. Acrux is also eligible for $87 million upon the issuance of marketing authorization, and for as much as $195 million in potential commercialization milestones.
Contract manufacturer Hollister-Stier (Spokane, WA) successfully completed a current good manufacturing practice audit by the Japanese Pharmaceutical and Medical Device Agency for a sterile-injectable client product. The audit led to a recommendation that Hollister-Stier be listed as an approved manufacturing site for its client’s product.
GlaxoSmithKline (London) appointed Jean Stephenne as chairman of GSK Biologicals. Stephenne retains his position as president of GSK Biologicals.