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BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
Date:5/6/2010

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., May 6, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We will continue to work closely with the agency through this final stage of the review process."

The new drug application (NDA) for BYDUREON was submitted in May 2009 and was based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA® (exenatide) injection. The agency issued a complete response letter to the companies in March 2010 and the companies responded to that letter in April 2010.

BYDUREON (pronounced by-DUR-
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SOURCE Amylin Pharmaceuticals, Inc.
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