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Amylin, Lilly Update on FDA Review of BYETTA(R) (exenatide) Injection Monotherapy Submission
Date:12/8/2008

SAN DIEGO and INDIANAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) is continuing with its review of the regulatory application for use of BYETTA(R) (exenatide) injection as stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009.

"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Orville G. Kolterman, senior vice president of research and development at Amylin Pharmaceuticals. "Importantly, we have not received any request for additional studies. We look forward to working closely with the agency as needed throughout the review process."

The regulatory application for use of BYETTA as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other BYETTA prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format.

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar
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SOURCE Eli Lilly and Company
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