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Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
Date:5/5/2009

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that a New Drug Application (NDA) for exenatide once weekly has been submitted to the U.S. Food and Drug Administration (FDA). Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week. Exenatide is the active ingredient in BYETTA(R) (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.

"The exenatide once weekly submission is an important milestone in the overall exenatide development program. The clinical data supporting this submission highlight the potential of exenatide once weekly to significantly advance the treatment of type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer of Amylin. "We remain committed to developing and commercializing a range of treatment options that address the important unmet needs of people living with diabetes."

Clinical components of the NDA include the DURATION-1 study and the meta-analysis of primary cardiovascular events across the BYETTA clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to BYETTA, which is administered twice daily. In this study, exenatide once weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseli
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SOURCE Amylin Pharmaceuticals, Inc.
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