New Drug Application for Exenatide Once Weekly Accepted for Rev...( SAN DIEGO INDIANAPOLIS and CAMBRIDGE ...)

SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by 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.

"Acceptance of the NDA submission for exenatide once weekly is an important milestone both in the exenatide development program and in the treatment of type 2 diabetes," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin Pharmaceuticals. "If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week."

About Diabetes

Diabetes affects more than 23 million people in the U.S. and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the U.S. and results in approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and
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