News Release

WASHINGTON, D.C., June 10, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced detailed findings from a study that showed BYETTA(R) (exenatide) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione (TZD) with or without metformin. Patients using BYETTA showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose and hemoglobin A1C (A1C), which improved by approximately 0.9 percent compared to the control group. Sixty-two percent of study participants using BYETTA who completed the full study reached target A1C of 7 percent or less. Less than 7 percent is the target for good glucose control as recommended by American Diabetes Association (ADA).

BYETTA treatment also resulted in a reduction in average body weight. BYETTA-treated patients lost an average of approximately three pounds of body weight, while those treated with placebo lost on average approximately one- half pound.

These findings were presented at the 66th Annual Scientific Sessions of the ADA in Washington, DC. BYETTA (pronounced bye-A-tuh), was approved in April 2005 as an adjunctive therapy for patients with type 2 diabetes who are not achieving blood sugar control on metformin and/or a sulfonylurea.

"In the context of treating the underlying defects in people with type 2 diabetes -- beta-cell dysfunction and insulin resistance -- using combination therapies is a sensible approach for patients," said Bernard Zinman, MD, Director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital in Toronto, Ontario and a lead author of the study. "These data indicate that the addition of BYETTA to TZDs can be a clinically meaningful treatment for patients."

In the first quarter of 2006, Amylin and Lilly submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval of BYETTA as an add-on therapy to treatment with a TZD with or without metformin in patients with type 2 diabetes.

    Key Findings
    A1C reduction:
    * At the end of the study, patients on BYETTA experienced an average
      reduction in A1C of 0.8 percent from baseline compared to an increase of
      0.1 percent in the control group.
    * Of patients completing the full study, 62 percent treated with BYETTA as
      a combination therapy achieved an A1C of 7 percent or less, compared to
      approximately 16 percent in the control group.

    Glucose measurements:
    * Patients treated with BYETTA had average fasting glucose, measured
      before breakfast, that was 27 mg/dL lower than the control group.
    * As measured by 7-point glucose monitoring, BYETTA significantly reduced
      average 2-hour post-meal glucose surges following breakfast and dinner
      by 34 mg/dL from baseline.
    * 7-point glucose monitoring throughout the day demonstrated a significant
      reduction in average glucose concentrations in patients receiving
      BYETTA.

    Weight change:
    * Patients in the BYETTA arm showed an average weight reduction of 3.3
      pounds compared with an average weight reduction of 0.4 pounds during
      treatment in the control arm.

    Hypoglycemia:
    * Rates of mild and moderate hypoglycemia (low blood sugar) were similar
      between the BYETTA and placebo treatments.  No severe hypoglycemia was
      reported.

    Other adverse events:
    * The most common adverse event was mild to moderate nausea reported by
      approximately 40 percent of the patients in the BYETTA group, compared
      to 15 percent of patients receiving placebo.

    Study Design/Protocol

233 patients with elevated A1C in spite of oral diabetes therapy were involved in the randomized, placebo-controlled, parallel, double-blind trial for 16 weeks. The trial was designed to determine if BYETTA can be used safely and effectively as adjunctive therapy to a TZD alone (~ 20 percent) or with a TZD and metformin (~ 80 percent), for people with type 2 diabetes. Study participants were randomized into either of two treatments: the first group received a fixed dose of BYETTA (5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for remainder of study) in conjunction with a TZD, with or without metformin, and the second group received placebo with a TZD, again with or without metformin. The average A1C at baseline was 7.9 percent.

These detailed findings supplement the primary results released in 2005.

About BYETTA

BYETTA is the first incretin mimetic, a class of drugs for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.(1)

Safety and Tolerability

Adverse events associated with BYETTA are generally mild to moderate in intensity. In clinical trials, the most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of nausea decreased over time in most patients.

Patients receiving BYETTA in combination with a sulfonylurea may be at a higher risk of hypoglycemia or low blood sugar. To reduce this risk, decreasing the dose of sulfonylurea may be considered. When patients begin taking BYETTA, the symptoms, treatment and conditions that predispose development of hypoglycemia should be explained to them, and the patient's usual instructions for hypoglycemia management should be reviewed and reinforced.

Patients should also be advised that treatment with BYETTA may lead to a reduction in appetite, food intake and/or body weight, and that there is no need to modify the dosing regimen due to such effects.

BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.

For complete safety profile and other important prescribing considerations, visit www.BYETTA.com.

About Incretin Mimetics

Incretin mimetics is a distinct class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose- lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. BYETTA is the first FDA-approved incretin mimetic.

About Diabetes

Diabetes affects an estimated 194 million adults worldwide(2) and more than 20 million in the United States.(3) Approximately 90 to 95 percent of those affected have type 2 diabetes, a condition characterized by failure of the pancreatic beta cells to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(4) Diabetes is the sixth leading cause of death by disease in the United States(3) and costs approximately $132 billion per year in direct and indirect medical expenses. Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(3)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of diabetes patients do not achieve target hemoglobin A1C levels (less than 7 percent according to ADA guidelines(5)) with their current treatment regimen.(6)

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first- in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin is located in San Diego, California with over 1200 employees nationwide. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism is available at www.amylin.com.

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

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products visit www.lillydiabetes.com.

This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of factors, including that BYETTA may be affected by unexpected new data, technical issues, or issues related to manufacturing and supply; future clinical trials may not replicate previous trial results; BYETTA may not prove to be an important therapeutic option; the request to expand the indication for BYETTA to include its use as an adjunct to TZDs may not receive regulatory approval; or risks and uncertainties inherent in the collaboration with, and dependence upon, Lilly or Amylin. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, or the pace of market acceptance. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recent SEC filings, including our Form 10-Qs. Amylin and Lilly disclaim any obligation to update these forward-looking statements.

P-LLY

REFERENCES

(1) Kolterman O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003; 88(7):3082-3089.

(2) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.

(3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf.

(4) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281(21):2005-2012.

(5) American Diabetes Association. Standards of medical care in diabetes 2006. Diabetes Care 2006;29:S4-42.

(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999;22:403-408.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )

SOURCE Eli Lilly and Company; Amylin Pharmaceuticals, Inc.

Jamaison Schuler of Lilly, +1-317-655-2111, cell: +1-317-997-1485; Alice Bahner of
Amylin, +1-858-642-7272, cell: +1-858-232-9072

http://www.prnewswire.com

Copyright (C) 2006 PR Newswire. All rights reserved.

News Provided by COMTEX