AMLN Amylin Pharmaceuticals, Inc. (MM)

Study Shows BYETTA(TM) Improves Blood Sugar Levels as Effectively as Insulin Glargine -- Patients on BYETTA also lost weight, while glargine patients gained weight -- SAN DIEGO, June 10 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced results from a study indicating that BYETTA(TM) (exenatide) injection improves blood sugar levels as effectively as insulin glargine (Lantus(R), Sanofi-Aventis) for people with type 2 diabetes failing to achieve acceptable blood sugar control on both metformin and a sulfonylurea, two common oral diabetes medications. Both treatments were effective in lowering blood sugar, and patients taking BYETTA experienced weight reductions while those on insulin glargine gained weight. The findings were presented at the American Diabetes Association's (ADA) 65th Scientific Sessions in San Diego, California. BYETTA (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics, and was approved by the Food and Drug Administration on April 28, 2005 for the treatment of type 2 diabetes. In this study, patients in each treatment group -- either BYETTA or insulin glargine -- lowered their average blood sugar (glucose) levels, as measured by hemoglobin A1C (A1C), by approximately 1 percent from baseline after six months of therapy. A1C measures a person's average glucose level over a three-month period and is often used by healthcare providers to assess blood glucose management. The ADA recommends a target A1C of less than 7 percent. Approximately half of the patients in each treatment group achieved an A1C of 7 percent or less. The study also showed that patients on BYETTA lost an average of five pounds, while patients on insulin glargine gained an average of four pounds. Weight gain is a common side effect of insulin therapy. In addition, BYETTA reduced peak glucose levels after meals better than insulin glargine. In contrast, insulin glargine was associated with lower fasting glucose levels. Both the BYETTA and insulin glargine groups had similar rates of symptomatic hypoglycemia (low blood sugar). Patients in both treatment groups continued their oral therapy as well, which included a sulfonylurea, a therapy known to cause hypoglycemia when used alone. "This is the first comparator study in which a non-insulin treatment for diabetes has demonstrated similar blood glucose control to insulin for patients who are failing to achieve treatment targets on oral medications," said Professor Robert Heine, Director of the Diabetes Center, VU University Medical Center in the Netherlands, and a lead author of the study's abstract presented today. "When considering the weight loss and achieved glucose control, the results of this study demonstrate that BYETTA can be an effective tool for the management of type 2 diabetes patients who cannot control their blood sugar using oral medications." Key Findings The primary objective of the study was to determine whether comparable glycemic control can be achieved in both groups, as evaluated by a change in A1C levels from baseline. Additional endpoints of the study included effects on weight, postprandial glucose excursions and incidence of hypoglycemia. A1C reduction: * At the end of the study, both treatment groups had achieved similar A1C reductions. BYETTA lowered A1C 1.0 percent while insulin glargine lowered A1C 1.1 percent. * Forty-six percent of patients in the BYETTA group achieved the target A1C level less than or equal to 7 percent compared to 48 percent in the insulin glargine group. * When measured against the American Association of Clinical Endocrinologist recommended target A1C of less than or equal to 6.5 percent, 31 percent of patients in the BYETTA group achieved this level compared to 24 percent in the insulin glargine group. Weight change: * Weight loss in the BYETTA arm: Patients using BYETTA showed an average weight reduction of 2.3kg (5.1 pounds). * Weight gain in the insulin glargine arm: On average, patients using insulin glargine gained 1.8kg (4.0 pounds). Postprandial excursions (post-meal blood glucose levels): * As measured by seven-point glucose monitoring, BYETTA reduced postprandial excursions (post-meal blood glucose levels) following breakfast and dinner. In contrast, insulin glargine predominantly reduced fasting glucose (at least eight hours after a meal). Hypoglycemia: * Rates of symptomatic hypoglycemia were similar between treatment groups. The most common adverse event for BYETTA was nausea (57 percent), which was generally mild-to-moderate and tended to decrease in frequency and severity over time. Six percent of BYETTA treated subjects discontinued due to nausea. Study Design/Protocol More than 500 patients were involved in the 26-week, multi-center, open- label, randomized, two-arm, parallel trial. The trial was designed to determine if BYETTA can be used safely and effectively in combination with metformin plus a sulfonylurea as an alternative to insulin glargine for type 2 diabetes patients. Patients were randomized into two arms. One arm received a fixed dose of BYETTA (5 micrograms twice-a-day for first four weeks, 10 micrograms twice-a- day for remainder of study, n=283) in conjunction with metformin and a sulfonylurea. The second arm received insulin glargine once daily beginning at 10 insulin units per day (n=268) in conjunction with metformin and a sulfonylurea. The glargine dose was titrated based on finger-stick blood glucose monitoring to achieve a pre-specified target fasting blood glucose level. Because of the fixed dosing of BYETTA, patients in that arm required no dose titration or additional finger-stick testing. The A1C baselines for the two groups were 8.2 plus or minus 1.0 percent for BYETTA and 8.3 plus or minus 1.0 percent for insulin glargine. About BYETTA BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and 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 stomach, liver, pancreas and brain that work in concert to regulate blood sugar.(1) BYETTA was approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea or both. BYETTA is currently available in pharmacies. For full Prescribing Information, visit http://www.byetta.com/. Safety and Tolerability Information 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, lowering the sulfonylurea dosage 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 http://www.byetta.com/. About Incretin Mimetics Incretin mimetics is a new class of therapeutics for use in the fight against type 2 diabetes. An incretin mimetic works to mimic the antidiabetic 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 agent of this new class of medications. About Diabetes Diabetes affects an estimated 194 million adults worldwide(2) and more than 18 million in the United States.(3) Approximately 90 to 95 percent of those affected have type 2 diabetes, a condition where the body does not produce enough insulin and/or the cells in the body do not respond normally to insulin.(3) Diabetes is the fifth leading cause of death by disease in the United States(4) 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. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism is available at http://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 http://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, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://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 future clinical trials may not replicate previous trial results; risks that BYETTA may not prove to be an important new therapeutic option, additional indications for BYETTA may not be received, or BYETTA may be affected by unexpected new data or technical issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Annual Reports on Form 10-K. Amylin and Lilly undertake no duty 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_2003.pdf. (4) Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002. National vital statistics reports; vol 53 no 5. Hyattsville, Maryland: National Center for Health Statistics. 2004. (5) American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005;28:S4-36S. (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 ) http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO DATASOURCE: Eli Lilly and Company; Amylin Pharmaceuticals, Inc. CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111, +1-317-457-2113 (cell); Eric Shearin of Amylin, +1-858-552-2200, x7177, +1-858-699-5514 (cell)

Copyright