Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-... (pleted the study whichenrolled patients ...)

Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study

Date:10/31/2007

pleted the study, which enrolled patients not achieving adequate glucose control with either diet and exercise or with use of oral glucose-lowering agents. The companies anticipate a regulatory submission to the U.S. Food and Drug Administration (FDA) by the end of the first half of 2009.

"Together with our collaboration partners Lilly and Alkermes, we are pleased that use of once-weekly exenatide met the primary endpoint with a greater reduction in A1C than BYETTA and with significant weight loss, both key measures of success in the management of type 2 diabetes," stated Orville G. Kolterman, M.D., Senior Vice President Clinical and Regulatory Affairs, Amylin Pharmaceuticals. "These data confirm the benefits of BYETTA as an important treatment option and suggest that, if approved, once-weekly exenatide has the potential to help patients improve their diabetes management. With these safety and efficacy data in hand, we are working diligently to complete the remaining steps required for our once-weekly exenatide regulatory submission by the end of the first half of 2009, and will make every effort to bring this therapy to patients as quickly as possible."

There was no major or severe hypoglycemia regardless of background therapy. As expected based on prior BYETTA studies, minor hypoglycemia with once-weekly exenatide use was limited to subjects using background sulfonylurea therapy. Once-weekly exenatide was associated with approximately 30 percent less nausea than BYETTA. Approximately one out of five subjects receiving once-weekly exenatide reported treatment-related nausea during the 30-week study. In both groups nausea was predominantly mild and transient. The antibody profile of subjects treated in this study was consistent with the previously reported profiles of BYETTA and once-weekly exenatide.

BYETTA -- the first and only FDA-approved incretin mimetic -- was approved in April 2005 and has been used by more than 700,000 patients since its in
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