Bydureon FDA Action Date Set For January 28, 2012

Amylin Pharmaceuticals, Inc. AMLN, Eli Lilly and Company LLY and Alkermes, Inc. ALKS today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the companies' BYDUREON™ (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a Class 2 resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes. "If approved, we believe BYDUREON will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the U.S.," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We will continue to work with the FDA through this stage of the review process." BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon