Amylin Pharmaceuticals, Inc. and Eli Lilly and Company BYETTA(R) Study Showed Sustained Blood Glucose Control Over Three Years in People with Type 2 Diabetes

CHICAGO, June 25 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced three- year, open-label study results that showed treatment with BYETTA(R) (exenatide) injection was associated with sustained blood sugar control and progressive weight loss in people with type 2 diabetes. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.

In this open-label extension study, 217 people with type 2 diabetes not achieving adequate blood sugar control on oral medication alone (metformin and/or sulfonylurea) were treated with BYETTA (10 mcg) in addition to their oral medication(s) for three years. Study participants treated with BYETTA and oral medication(s) showed sustained reductions in blood sugar as measured by A1C, a test that measures average blood sugar levels over approximately three months, and fasting blood glucose levels (-1.0 +/- 0.1 percent and -23.5 +/- 3.8 mg/dL, respectively).(1) After three years of BYETTA treatment, 46 percent of study participants achieved the American Diabetes Association's recommended target A1C of 7 percent and 30 percent of participants achieved an A1C of 6.5 percent.(2) Weight loss from baseline was progressive, with participants losing on average 11.68 +/- 0.88 lbs at three years. In addition, one in four patients lost an average of 28.66 lbs.

Pancreatic beta cells (beta-cells) are responsible for producing insulin, a hormone that helps the body convert glucose (blood sugar) into energy.(3) Type 2 diabetes develops when the pancreas does not produce enough insulin for the body to adequately regulate blood sugar levels, or the body is unable to use the insulin efficiently. In this study, BYETTA treatment was assessed for improvements in pancreatic beta-cell function in a subset of 92 study participants. HOMA-B (Homeostasis Model Assessment), a measure of pancreatic beta-cell function, improved by 17 percent from baseline over three years.

"Type 2 diabetes is associated with impaired insulin production in the pancreas that progressively deteriorates over time," said John Buse, Chief of the Division of General Medicine and Clinical Epidemiology at the University of North Carolina School of Medicine in Chapel Hill, NC. "Although currently BYETTA is not indicated to improve beta cell function, these study findings suggest that long-term BYETTA treatment may help improve insulin production, a root cause of the condition, and help people with type 2 diabetes better control their blood sugar levels."

BYETTA was generally well-tolerated in this study, and side effects were consistent with those seen in previous studies. In clinical trials and post- approval adverse event reports, the most common side effect is mild-to- moderate nausea, which affects fewer than half of patients and usually decreases over time.

BYETTA is indicated for use as an adjunctive therapy for people with type 2 diabetes who are not achieving blood sugar control using metformin, a sulfonylurea, or a thiazolidinedione. Over three million prescriptions have been written in the U.S. since being approved by the Food and Drug Administration (FDA) in 2005. For more information, visit www.BYETTA.com.

About BYETTA(R) (exenatide) injection

BYETTA is the first in a class of drugs called incretin mimetics 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 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. For full prescribing information, visit www.BYETTA.com.

About Diabetes

Diabetes affects more than 20 million in the United States and an estimated 246 million adults worldwide.(4),(5) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(6)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(7)

Important Safety Information for BYETTA(R) (exenatide) injection

BYETTA improves glucose (blood sugar) control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems with the stomach or food digestion, or those who have severe kidney disease. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

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

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. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego, California with over 1,600 employees nationwide. For more information about Amylin and the company's diabetes products, visit www.amylin.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.

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, Indiana, 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.

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 risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition, unexpected new data, technical issues, clinical trials not confirming previous results or predicting future results, label expansion requests not being submitted in a timely manner or receiving regulatory approval, or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to update these forward-looking statements.

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(1) American Diabetes Association's Diabetes Dictionary. Available at: http://www.diabetes.org/diabetesdictionary.jsp?pageID=1&exitDictionaryTo=. Accessed June 8, 2007.

(2) American Diabetes Association. "Standards of Medical Care for Diabetes - 2007. Diabetes Care: 30 (Supplement 1), January 2007.

(3) American Diabetes Association's Diabetes Dictionary. Available at: http://www.diabetes.org/diabetesdictionary.jsp?pageID=2&exitDictionaryTo=. Accessed June 8, 2007.

(4) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed June 14, 2007.

(5) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.

(6) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 14, 2007.

(7) Saydah SH, Fradkin J and Cowie CC. "Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes." JAMA: 291(3), January 21, 2004.

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CONTACT: Media: Kindra Strupp of Lilly, +1-317-277-5170, cell,+1-317-554-9577; or Alice Bahner Izzo of Amylin, +1-858-642-7272, cell,+1-858-232-9072