King Pharmaceuticals and Wyeth have entered into an amended and restated co-promotion agreement regarding King's angiotensin converting enzyme (ACE) inhibitor Altace (ramipril). Effective Jan.1, 2007, King will assume full responsibility for the selling and marketing of Altace. For the remainder of 2006, the Wyeth sales force will continue to promote the product with King and Wyeth will receive an undisclosed fee thereafter through 2010. Meanwhile, King and Depomed have entered into a co-exclusive agreement to commercialize Depomed's Glumetza (metformin hydrochloride extended-release tablets) product. Under the terms of the agreement, King will assume responsibility for selling Glumetza in the US and Puerto Rico, while Depomed has the right to co-promote the product using its own sales force at some point in the future.
The FDA issued a warning letter to vaccines maker Sanofi Pasteur due to what it called “significant deviations” from good manufacturing practices. The letter follows an inspection of Sanofi Pasteur’s facility in Swiftwater, PA, in April.
Sanofi Pasteur, a division of drug giant Sanofi-Aventis, makes a range of vaccines, including influenza, pertusis, diptheria and polio. It is also working on an H5N1 influenza vaccine. During the inspection, FDA said its investigators documented significant deviations from current good manufacturing practices in the manufacture of licensed biological products and in monovalent concentrate batches of its influenza vaccine Fluzone.