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Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
Date:12/11/2008

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 /PRNewswire/ -- 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) recently indicated that the ongoing extension of the DURATION-1 study is appropriate to use as the basis for demonstrating comparability between intermediate-scale clinical trial material made in Alkermes' manufacturing facility, and commercial-scale drug product made at Amylin's manufacturing facility.

"Following feedback from FDA, we now have an appropriate pathway to demonstrate manufacturing comparability of exenatide once weekly. This is a very important step for the submission of exenatide once weekly," said Orville G. Kolterman, M.D., senior vice president, research and development at Amylin Pharmaceuticals. "We remain confident that our NDA submission is on track to be completed by the end of the first half of 2009."

Final acceptance of the comparability data is dependent upon DURATION-1 study extension results that are expected in early 2009.

DURATION Program Update

The overall DURATION clinical program, designed to demonstrate superiority of exenatide once weekly as compared to other medications in the treatment of type 2 diabetes, remains on track. The companies recently initiated DURATION-4, the fourth planned DURATION study. The DURATION-4 study examines exenatide once weekly as a monotherapy treatment compared to either metformin, a thiazolidinedione (TZD) or a dipeptidyl peptidase-4 (DPP-4) inhibitor. The double-blind study is expected to include a
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SOURCE Eli Lilly and Company
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