'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.'

Byetta is indicated as an adjunctive therapy for patients who have not achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications.

Byetta (pronounced bye-A-tuh) is the trade name for exenatide, the first in a new class of medicines known as incretin mimetics. Byetta will be available to pharmacies by June 1, 2005, according to Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY), manufacturers of the drug.

Restores Response of Insulin-Producing Cells

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 accomplishes this through several actions, including the stimulation of insulin secretion only when blood sugar is high and the restoration of 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," he added.

Approvable as Stand-Alone Therapy

"Successfully managing diabetes is a daily struggle for millions of Americans," said Ginger L. Graham, President and Chief Executive Officer, Amylin Pharmaceuticals, Inc.

"Often, current treatments do not provide adequate blood sugar control leaving patients and caregivers frustrated. Byetta, a first-in-class medicine, is a new therapy for those who are not able to effectively control their blood sugar with their current oral medications," she noted.

"With BYETTA's demonstrated effects on blood sugar and its safety profile, physicians and patients now have a new approach to fight the growing diabetes epidemic," said Sidney Taurel, Chairman and Chief Executive Officer, Eli Lilly and Company.

In addition to approving Byetta for use as an adjunct to existing oral medicines, the FDA also stated that Byetta is approvable as a stand-alone therapy (monotherapy) for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six- month review.

Byetta is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals. Byetta will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device, say the companies.