Eli Lilly and Company

Study Demonstrated Once-Weekly Exenatide LAR Improved Glucose Control in Patients with Type 2 Diabetes

    Copenhagen, Denmark (ots/PRNewswire) -

    Eli Lilly and Company (NYSE: LLY), Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), and Alkermes, Inc. (Nasdaq: ALKS) today announced detailed results from a safety and efficacy study of the long-acting release (LAR) formulation of exenatide. Data from the study demonstrated that 86 percent of patients using the higher of two doses of the once-weekly formulation of exenatide were able to achieve recommended levels of glucose control, as measured by hemoglobin A1C (HbA1C) with an average improvement of approximately 2 percent compared to placebo. These study findings were presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Copenhagen.

    The study was conducted in 45 patients with type 2 diabetes unable to achieve adequate glucose control with metformin or a diet and exercise regimen. The patients received a once-weekly subcutaneous injection of exenatide LAR (either 0.8 mg or 2.0 mg) or placebo. After 15 weeks of treatment there was a 12-week safety monitoring period during which no study medication was administered.

    Dose-dependent improvements in HbA1C and weight loss were observed at 15 weeks. At the beginning of the study, the average HbA1C of study participants was approximately 8.5 percent. In subjects receiving the 2.0 mg dose of exenatide LAR, the average reduction in HbA1C was 1.7 percent compared to an increase of 0.4 percent in the placebo group. Those receiving the 0.8 mg dose improved with an average decrease in HbA1C of 1.4 percent.

    In patients administered 0.8 mg or 2.0 mg of exenatide LAR, 33 percent and 86 percent achieved HbA1C levels of 7 percent or less, respectively. None of the patients given placebo achieved this target level of glucose control. HbA1C is a reflection of a person's average glucose level over approximately three months and is often used by doctors as a measure of glucose management.

    Fasting blood glucose levels were reduced by an average of 39 mg/dL in the 2.0 mg arm and 43 mg/dL in the 0.8 mg arm compared to an average increase of 18 mg/dL in the placebo group at week 15. Average fasting blood glucose level at the beginning of the study was 179 mg/dL. Patients who received 2.0 mg of exenatide LAR also experienced average reductions in body weight of 3.8 kilograms (8.4 pounds) at week 15 with no evidence of plateau at this point in time; body weight remained essentially unchanged for the 0.8 mg and placebo groups. The most frequent adverse event was mild nausea, experienced by 27 percent of subjects in the 2.0 mg dose group and 19 percent of subjects in the 0.8 mg dose group compared to 15 percent in the placebo group. No severe hypoglycemia was observed, and no subjects receiving either dose of exenatide LAR withdrew because of adverse events. These detailed findings supplement the preliminary results released in 2005.

    "In this study, the long-acting formulation of exenatide improved glycemic and weight control and was well tolerated as a combination therapy with metformin or as stand alone therapy with diet and exercise," said Michael Trautmann, M.D., Medical Fellow at Eli Lilly and Company and an author of the study. "These early results suggest exenatide LAR can be clinically beneficial to patients with type 2 diabetes."

    Exenatide LAR uses the proprietary Medisorb(R) drug-delivery technology developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body, where they degrade slowly -- gradually releasing the drug at a carefully controlled rate.

    Exenatide is the first in a new class of medicines known as incretin mimetics and was approved for use in the United States by the U.S. Food and Drug Administration (FDA) in April 2005 for the treatment of type 2 diabetes. Exenatide is injected twice daily. The U.S. is the first country in the world that has received regulatory approval for exenatide. In late 2005, Lilly submitted exenatide for approval in the European Union. Lilly, Amylin, and Alkermes are working together to develop a sustained release, subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb(R) injectable long-acting release drug delivery technology. Exenatide LAR has not been approved by the FDA for marketing in the United States.

    About exenatide

    Exenatide is the first incretin mimetic, a new class of drugs for the treatment of type 2 diabetes. Exenatide 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)

    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. Exenatide is the first FDA-approved incretin mimetic.

    About Diabetes

    Diabetes affects an estimated 194 million adults worldwide(2) and around 48.4 million in Europe.(3) Approximately 90 to 95 percent of those are 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.(4) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(3) 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)(5). The calculated estimates of the costs of diabetes care in Europe amount to 42.8 million International Dollars per year.(6)

    About Lilly, Amylin, and Alkermes

    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, IN, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

    Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin's research and development activities leverage the company's expertise in metabolism to develop promising therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1200 employees nationwide.

    Alkermes, Inc. is a biotechnology company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases. The Company has two commercial products and a pipeline of extended-release injectable products and pulmonary products based on its proprietary technology and expertise. The Company's headquarters are in Cambridge, Massachusetts, and it operates research and manufacturing facilities in Massachusetts and Ohio.

    This press release contains forward-looking statements, which involve risks and uncertainties within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are neither promises nor guarantees, and the businesses of Lilly, Amylin, and Alkermes are subject to significant risks and uncertainties. Actual results may differ materially from the forward-looking statements discussed in this press release. These forward-looking statements include risks and uncertainties, including but not limited to, that current or future clinical trials will not confirm previous results; risks and uncertainties that Amylin will be able to complete manufacturing scale-up and construction and validation of its manufacturing facility on a timely basis, or at all; risks and uncertainties inherent in the collaboration with and dependence upon Lilly, Amylin and/or Alkermes; risks and uncertainties regarding the drug discovery and development process, including whether exenatide LAR will receive regulatory approvals, be commercialized or prove to be commercially successful. These and additional risks and uncertainties are described more fully in Lilly, Amylin, and Alkermes' filings with the United States Securities and Exchange Commission, including their recently filed Form 10-Qs. The parties disclaim any obligation to update forward-looking statements.



    (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-C026-2 FD3-87B73F80BC22682A. Accessed April 12, 2005.

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

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

    (6) The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003: 186.

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ots Originaltext: Eli Lilly and Company; Amylin Pharmaceuticals, Inc.; Alkermes, Inc.
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