Eli Lilly and Company

BYETTA(R) Study Showed Sustained Blood Glucose Control Over Three Years in People with Type 2 Diabetes

    Chicago (ots/PRNewswire) -

    -- BYETTA offers added benefits of progressive weight loss in an analysis of the longest extension study to date --

    Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) 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 sulphonylurea) completed treatment with exenatide (10 mcg) in addition to their oral medication(s) for three years. Study participants treated with exenatide and oral medication(s) showed sustained reductions in blood sugar as measured by HbA1c, a test that measures average blood sugar levels over approximately three months, and fasting blood glucose levels (-1.0 +/- 0.1 percent and 1.3 +/- 0.2 mmol/L [-23.5 +/- 3.8 mg/dL], respectively).(1) After three years of exenatide treatment, 46 percent of study participants achieved the American Diabetes Association's recommended HbA1c target of 7 percent and 30 percent of participants achieved an HbA1c of 6.5 percent.(2) Weight loss from baseline was progressive, with participants losing on average 5.3 +/- 0.40 kg (11.68 +/- 0.88 lbs) at three years. In addition, one in four patients lost an average of 13.0 kg (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, exenatide treatment was assessed for improvements in pancreatic beta-cell function in a subset of 92 study participants with evaluable data. 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. "These study findings suggests that long-term exenatide treatment helps people with type 2 diabetes achieve sustained control of their blood sugar levels."

    Exenatide was generally well-tolerated in this study, and the 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 nausea, most of which was mild to moderate, affecting approximately half of patients and usually decreases over time.

    About BYETTA(R) (exenatide) injection

    BYETTA is the first in a class of drugs for the treatment of type 2 diabetes called incretin mimetics. 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 in the European Union as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin and/or a sulphonylurea, two common oral diabetes medications. BYETTA provides sustained HbA1c control, low incidence of hypoglycaemia when used with metformin and progressive weight loss.

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

    In clinical studies, the most common side effects were hypoglycaemia (low blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomiting and diarrhea. For the full list of all side effects reported with BYETTA, see the Package Leaflet. BYETTA should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.

    About Diabetes

    Diabetes affects an estimated 246 million adults worldwide and more than 48 million in Europe.(4,5) Approximately 90 to 95 percent of those affected by 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.(6) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(5) In virtually every developed society, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation, as well as death through its effects on cardiovascular disease (70-80 percent of people with diabetes die of cardiovascular disease).(7) The calculated estimates of the costs of diabetes care in Europe amount to 42.8 billion International Dollars per year.(8)

    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 1,700 employees nationwide. For more information about Amylin, 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.

    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 United States Securities and Exchange Commission documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to update these forward-looking statements.

    P-LLY

    REFERENCES

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

    4 The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F 80BC22682A. Accessed June 14, 2007.

    5 The International Diabetes Federation, Prevalence / All diabetes. Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.

    6 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.

    7 The International Diabetes Federation, Complications. Available at http://www.eatlas.idf.org/Complications/

    8 The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003: 186.

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Contact:
Derin Denham, Eli Lilly and Company, +1-317-277-6749 office, or
+1-317-370-1435 cell, or Alice Bahner Izzo, Amylin Pharmaceuticals,
Inc., +1-858-642-7272 office, or +1-858-232-9072 cell;  Photo:  
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO , AP
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