Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced the achievement of the first development milestones in the global collaboration agreement for exenatide (synthetic exendin-4). The milestones mark the successful completion of the exenatide Phase 3 pivotal studies and a complete review of the full statistical data from the studies. Pursuant to the collaboration agreement, Lilly has agreed to pay Amylin development milestone payments totaling $35 million.

"These milestone payments acknowledge the successful, on-time completion of three major long-term clinical studies," said Ginger Graham, president and chief executive officer at Amylin Pharmaceuticals, Inc. "We believe the data from these studies provide a solid base for the exenatide New Drug Application, currently projected for submission to the FDA in mid-2004."

"The successful completion of the exenatide Phase 3 pivotal trials reflects the quality of our ongoing collaboration with Amylin Pharmaceuticals and marks an important milestone in our commitment to remain at the forefront of diabetes research and treatment," said John C Lechleiter, PhD, executive vice president, pharmaceutical products and corporate development at Lilly. "Data from the exenatide Phase 3 programme is encouraging and we are hopeful that exenatide will represent a significant advance in the treatment of type 2 diabetes."

Lilly has agreed to relinquish any future rights to convert the $35 million milestone payments into Amylin common stock. Prior to this decision, Lilly retained the right to convert the milestone payments to Amylin common stock if the New Drug Application were not accepted for filing by the US FDA on or before Dec 31 2005.

Exenatide, the first in a new class of investigational compounds known as incretin mimetics, is being developed by Amylin Pharmaceuticals and Eli Lilly and Company as a potential treatment for type 2 diabetes. The companies announced the completion of the long-term clinical trials for exenatide in November 2003, of which the results will form the basis of a planned submission to the FDA.

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic disorders through the discovery, development and commercialization of innovative, cost-effective medicines.