Amylin Wins FDA Approval for Once-Weekly Diabetes DrugMonday, January 30, 2012
San Diego-based Amylin Pharmaceuticals Inc. said Jan. 27 that the U.S. Food and Drug Administration approved its drug Bydureon, the first once-weekly injection to treat type 2 diabetes.
Shares of the publicly traded company jumped more than 17 percent to $14.23 in after-hours trading on Nasdaq after closing at $12.14.
The drug, which controls blood-sugar levels, will be in pharmacies in February, Amylin said, in a joint statement with Dublin, Ireland-based development partner Alkermes Plc.
“Bydureon represents an important milestone in Amylin’s promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes,” said Daniel M. Bradbury, Amylin president and CEO, in a company statement.
Amylin on Nov. 8 announced that it would be cutting ties with its decade-long commercialization partner Eli Lilly and Co. and taking on full control of its exenatide diabetes drug franchise, which includes the drugs Bydureon and Byetta.
Amylin had filed a lawsuit against Eli Lilly in May, alleging anticompetitive activity after the Indianapolis-based pharmaceutical giant entered into a marketing deal with Germany’s Boehringer Ingelheim GmbH to sell a competing diabetes drug. That litigation was resolved through the companies’ agreement to part ways.
— Kelly Quigley