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Amylin and Lilly Announce FDA Approval of BYETTA™ (exenatide) injection

A New First-in-Class Treatment for Patients with Type 2 Diabetes

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announce that the U.S. Food and Drug Administration (FDA) has approved BYETTA™ (exenatide) injection as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications.

BYETTA (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics. BYETTA is available to pharmacies by June 1, 2005.

BYETTA improves blood sugar control by lowering both post meal and fasting glucose levels leading to better long-term control as measured by hemoglobin A1C. BYETTA does this through several actions, including the stimulation of insulin secretion only when blood sugar is high and by restoring the first-phase insulin response, an activity of the insulin producing cells in the pancreas that is lost in patients who have type 2 diabetes. Most patients in the long-term BYETTA clinical studies also experienced reductions in weight.

“The availability of a treatment that lowers blood sugar and has the potential to help restore the response of the body's insulin-producing cells is an exciting advance for patients with type 2 diabetes,” said Dr. David Kendall, Medical Director at International Diabetes Center in Minneapolis, Minnesota, and an investigator for the BYETTA clinical studies.

BYETTA is a truly unique tool for the management of type 2 diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications.

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San Diego, CA and Indianapolis, IN – April 29, 2005
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