BYDUREON™ Reply Submitted to FDA

Amylin Pharmaceuticals, Inc. AMLN, Eli Lilly and Company LLY and Alkermes, Inc. ALKS today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes. The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class 2 resubmission requiring up to six months for review. The reply submission includes results from the recently completed thorough QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals as defined by the FDA's published guidance. The reply also contains results from the DURATION-5 study, which compared the commercial formulation of BYDUREON to BYETTA® (exenatide) injection. Additionally, it includes an update of safety information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario. "We worked expeditiously to complete the requested tQT study and consulted with the FDA throughout the process," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "We are confident that the study results and our detailed submission have addressed the requirements outlined by the FDA, and we remain committed to making BYDUREON available to patients in the U.S. as soon as possible." BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is an investigational medication for type 2 diabetes 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, 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-like peptide-1 (GLP-1) receptor agonist class of medications.