SAN DIEGO and INDIANAPOLIS, August 27 /PRNewswire/ --
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA(R) (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin's and Lilly's corporate websites after the call.
Since 2006, the U.S. prescribing information for exenatide has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between exenatide and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies.
"At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products," said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. "It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on exenatide are consistent with pancreatitis in the general population. We believe exenatide continues to have a positive benefit-risk profile for patients with type 2 diabetes."
About BYETTA(R) (exenatide) Injection
Exenatide is the first and only approved incretin mimetic, a 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.(2) Exenatide 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. Since the U.S. market introduction in June 2005, approximately one million patients worldwide have been treated with exenatide.
Diabetes affects an estimated 246 million adults worldwide and more than 48 million in Europe.(3,4) Approximately 90 to 95 percent of those are affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta-cell to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(5) In western countries, around 90 percent of type 2 diabetes cases are attributable to weight gain.(6)
Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(7) 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).(8) The total cost of caring for people with diabetes in Europe is estimated between 28 billion and 53 billion Euros per year. The calculated estimates of the costs of diabetes care in Europe amount to 42.8 billion International Dollars per year.(9)
Important Safety Information for exenatide
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 exenatide, see the Package Leaflet. Exenatide should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.
About Incretin Mimetics
Incretin mimetics are a distinct class of agents used to treat type 2 diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose- lowering actions of the naturally occurring human incretin hormone GLP-1. 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.
About Amylin and Lilly
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 potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California with over 2,000 employees in the United States.
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 healthcare 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.
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 exenatide and the revenues generated from exenatide may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; new drug applications and label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for exenatide 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's and Lilly's most recently filed SEC including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.
(1) Noel R, Braun D, Patterson R, Bloomgren G. Increased risk of acute pancreatitis observed in patients with type 2 diabetes. 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. Copenhagen, Denmark. International Society for Pharmacoepidemiology: 200
(2) 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.
(3) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed on May 22, 2008.
(4) The International Diabetes Federation, Prevalence / All diabetes. Available at: http://www.eatlas.idf.org/Prevalence/All_diabetes/. Accessed on May 22, 2008.
(5) 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.
(6) The International Diabetes Federation Diabetes Atlas. Available at: http://www.eatlas.idf.org/Obesity_and_type_2_diabetes/. Accessed on May 22, 2008.
(7) The International Diabetes Federation, Prevalence / All diabetes. Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/. Accessed on May 22, 2008.
(8) The International Diabetes Federation, Complications. Available at http://www.eatlas.idf.org/Complications/. Accessed on May 22, 2008.
(9) The International Diabetes Federation, Diabetes Atlas, Second edition. Available at: http://www.eatlas.idf.org/Costs_of_diabetes/Calculated_cost_estimates/. Accessed August 26, 2008
Web site: http://www.amylin.com
Media: Derin Denham, Lilly, +1-317-277-6749 office, +1-317-370-1435 cell; or Alice Izzo, Amylin, +1-858-642-7272 office, +1-858-232-9072 cell