Amylin Pharmaceuticals and Eli Lilly have entered into a product-supply agreement for exenatide LAR, for type 2 diabetes. Lilly will pay $125 million to Amylin, which will supply product for sales in the US and to Lilly for OUS sales. Lilly will also reimburse Amylin for upgrades made at the exenatide manufacturing facility in West Chester, Ohio.
Unfortunately, on November 4, Amylin reported that its regulatory approval timeline for the drug would likely be delayed, sending its stock shares plummeting. It reported that FDA had rejected study data meant to show that exenatide batches made by partner Alkermes were equivalent to batches made at Amylin's Ohio facility. Many forecasters, however, were not surprised by the additional delay and FDA’s extreme caution.
Bilcare Global Clinical Supplies, a provider of clinical trial supplies and services, signed a service agreement with World Courier to use depots in Argentina, Brazil, Colombia, Chile, Mexico, Peru, and Russia. The new locations supplement Bilcare’s existing network in India, the UK, Singapore, and the US. Bilcare is planning additional global depot locations.
GlaxoSmithKline Biologicals and AFFiRiS signed a collaboration agreement granting GSK exclusive rights to AFFiRiS’s Alzheimer’s disease vaccine programs.
Patheon has opened a new GMP development services suite at its Whitby Development Centre in Ontario, Canada. The 2,500-square-foot addition is for the manufacturing of products for Phase I and II clinical trials, and for early-phase pharmaceutical development.
Avid Bioservices, a manufacturing services provider, signed a manufacturing supply agreement with Catalyst Biosciences, a biotechnology company. Avid will produce clinical-grade material in support of Catalyst’s clinical candidate, CB 813, an improved version of factor VIIa for the treatment of acute bleeding in hemophilia patients. Avid will begin CGMP manufacturing to provide cell bank preparation, process development, and preparation of the manufacturing portion of the FDA investigational new drug application.
Covidien will begin a $100-million, five-year plant expansion of its St. Louis facilities, according to the St. Louis Business Journal. The company expects the expansion to add 30 new research jobs and enhance its pharmaceutical development capabilities.
Beginning in 2009, Novartis will operate under a new commercial model, the "Customer Centric Initiative”—a model of five new regional units that have cross-functional responsibility for the full primary care product portfolio. This replaces the company’s nationally managed sales force, and will result in staff cuts.