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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

l trials not predicting future results; label expansion requests or NDA filings, including the NDA filing mentioned in this press release, not being submitted in a timely manner; regulatory approval being delayed or not received; or manufacturing and supply issues. The potential for BYETTA and/or exenatide once weekly may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the development and commercialization of pharmaceutical products including those inherent in the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. These and additional risks and uncertainties are described more fully in Amylin's, Lilly's and Alkermes' most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements.


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(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed June 2, 2008.

(ii) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 8, 2008.

(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 8, 2008.

(iv) Saydah SH, Fradkin J and Cowie CC. "Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed
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SOURCE Eli Lilly and Company
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