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Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events
Date:3/26/2009

de once weekly on major cardiovascular events, compared to standard of care with traditional antidiabetes medications. The global study will be sponsored by Amylin and Lilly, and active discussions are ongoing to have the study led by two academic research centers, The Diabetes Trial Unit at the Oxford Centre for Diabetes (Oxford, England) and Duke Clinical Research Institute at Duke University (Durham, N.C.). The steering committee for this study is chaired by Professor Rury Holman, FRCP, director, Diabetes Trial Unit, Oxford University, and Robert M. Califf, M.D., vice chancellor for clinical research and professor of medicine in the Division of Cardiology at Duke.

"There is a major unmet need for proven therapies that can help reduce the excess cardiovascular morbidity and mortality associated with type 2 diabetes," commented Professor Holman. "This trial is designed to determine the extent to which exenatide may reduce cardiovascular risk, in addition to lowering glucose."

Exenatide Once Weekly NDA Submission On Track By End Of Second Quarter 2009

The analyses to demonstrate comparability necessary for the regulatory submission of exenatide once weekly have been successfully completed and will be part of the New Drug Application (NDA) submitted to FDA. These analyses include data from the ongoing extension of the DURATION-1 study, and will be used to support comparability between intermediate-scale clinical trial material made in Alkermes' manufacturing facility and commercial-scale drug product made at Amylin's manufacturing facility.

"Both the manufacturing comparability data and the meta-analysis of the exenatide clinical trial database are key components of our submission. We believe that the material made at commercial scale is comparable to the clinical-scale material, and we are confident that we will have a strong submission package for exenatide once we
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SOURCE Amylin Pharmaceuticals, Inc.
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