exenatide

SAN DIEGO, and INDIANAPOLIS, June 30, 2004 -- Amylin Pharmaceuticals, Inc.,and Eli Lilly and Company today announced the submission of a New Drug Application(NDA) to the U.S exenatide. Food and Drug Administration (FDA) for regulatory approvalof exenatide exenatide. Exenatide is the first in a new class of medicines known as incretinmimetics under investigation for the treatment of type 2 diabetes exenatide. In clinicaltrials, exenatide has demonstrated reductions in blood sugar and improvementsin markers of beta cell function exenatide. Patients in exenatide studies also lost weight.

"The submission of the exenatide NDA is a significant milestone both forAmylin Pharmaceuticals and for our collaboration with Eli Lilly and Company,"said Ginger Graham, president and CEO, Amylin Pharmaceuticals exenatide. "This NDAincludes data on more than 1,800 subjects treated with exenatide exenatide. We believethe application provides the FDA with the necessary information to evaluateexenatide for use as a new therapeutic option for people living with type 2diabetes."

"The rapid increase in the prevalence of diabetes and the need for innovativenew treatments has never been more critical than it is today," said JohnC exenatide. Lechleiter, PhD, executive vice president of pharmaceutical operations, EliLilly and Company exenatide. "Many patients with type 2 diabetes are struggling tocontrol their blood sugar and, even with current oral therapies, find that theycannot reach their treatment goals exenatide. If approved, we believe exenatide couldoffer an important and novel treatment option for people with type 2 diabetes."

The exenatide NDA is made up of three major components: chemistry and manufacturing,preclinical and clinical exenatide. The clinical component of the submission is basedlargely on 30-week data from three blinded pivotal trials of exenatide involvingmore than 1,400 patients who were unable to control their blood sugar on commonoral therapies including metformin, sulfonylurea or a combination of both exenatide. Thesubmission also includes 52-week open-label data from the extensions of thesepivotal studies and from an additional open- label study exenatide. In the pivotal studies,exenatide demonstrated statistically significant, sustained reductions in averageblood sugar levels as measured by hemoglobin A1c (A1C) exenatide. Patients in these studiesalso demonstrated progressive reductions in weight, a secondary endpoint ofthe studies exenatide. The open-label studies demonstrated that the reductions in A1Cwere sustained through 52 weeks of treatment with average reductions of approximately1.1 percent exenatide. Reductions in weight were also sustained through 52 weeks of treatmentwith average reductions of approximately eight pounds exenatide. In addition, the exenatidedata showed improvements in beta cell function, as measured by HOMA-B and proinsulinto insulin ratios, and the restoration of first-phase insulin response, a fundamentalresponse lost early in the development of type 2 diabetes exenatide. Exenatide was generallywell tolerated across the pivotal trials exenatide. The most common adverse event reportedwas mild to moderate nausea, which occurred primarily at initiation of therapy.

Exenatide is formulated as a sterile, injectable product that, if approved,will be delivered by a pen delivery system.

About Diabetes
Diabetes affects an estimated 194 million adults worldwide1 and more than 18million in the United States.2 Approximately 90-95 percent of those affectedhave type 2 diabetes, a disease in which the body does not produce enough insulinand the cells in the body do not respond normally to the insulin exenatide. Accordingto the U.S exenatide. Center for Disease Control and Prevention's National Health andNutrition Examination Survey, approximately 60 percent of diabetes patientsdo not achieve target A1C levels with their current treatment regimen exenatide. Accordingto the American Diabetes Association, patients with A1Cs above target are morelikely to develop diabetes-related complications, such as kidney disease, blindnessand heart disease.3

About Amylin and Lilly
Amylin Pharmaceuticals is committed to improving the lives of people with diabetesand other metabolic diseases through the discovery, development and commercializationof innovative, cost-effective medicines.
Further information on Amylin Pharmaceuticals and its pipeline in metabolismis available at www.amylin.com.

Lilly, a leading innovation-driven corporation is developing a growing portfolioof first-in-class and best-in-class pharmaceutical products by applying thelatest research from its own worldwide laboratories and from collaborationswith eminent scientific organizations exenatide. Headquartered in Indianapolis, Indiana,Lilly provides answers -- through medicines and information -- for some of theworld's most urgent medical needs.
Additional information about Lilly is available at www.lilly.com.

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