Meta-analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Pre

NEW ORLEANS, June 8 /PRNewswire/ --

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a meta-analysis of cardiovascular (CV) events that showed no increased risk of CV events associated with BYETTA(R) (exenatide) injection use compared to a pooled comparator group treated with either placebo or insulin. This analysis applied the principles that were described in the U.S. Food and Drug Administration's (FDA's) guidance for evaluating CV risk in type 2 diabetes agents. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

In the meta-analysis of 12 completed, randomized, controlled clinical trials of 12-52 weeks, the unadjusted rate at which patients experienced at least one CV event was 2.0 percent for exenatide and 2.6 percent for the comparator group; the relative risk between exenatide and the comparator group was 0.69 with a 95 percent confidence interval of 0.46-1.03.

"The data from this analysis are reassuring and consistent with clinical trial data that show favorable effects of exenatide on cardiovascular risk factors," said Byron Hoogwerf, M.D., clinical research physician for Eli Lilly and Company. "Amylin and Lilly intend to initiate a large cardiovascular outcomes trial to further evaluate safety and to determine if there are cardiovascular benefits of exenatide treatment."

"Patient safety is of utmost concern at Amylin and Lilly," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. "Given that people living with diabetes have two-to four-times greater risk of cardiovascular disease compared to people who don't have diabetes, we are comforted to have data that showed patients treated with exenatide had no increased risk of cardiovascular events and that exenatide may offer a potential cardiovascular benefit."

Study Design and Findings

In this integrated analysis, 2,316 exenatide subjects and 1,629 pooled comparator subjects were treated for a total of 1,072 and 780 patient-years of exposure, respectively. The unadjusted incidence of experiencing at least one CV event was 2.0 percent for exenatide and 2.6 percent for pooled comparator; the relative risk between exenatide and pooled comparator was 0.69 (95 percent confidence interval: 0.46-1.03). The Exposure Adjusted Incidence Rate (expressed as per 1,000 patient years) was 43.4 for exenatide and 54.4 for pooled comparator with a relative risk 0.80 (95 percent confidence interval: 0.53-1.21). CV events included stroke, myocardial ischemia, myocardial infarction, cardiac mortality, arrhythmia, revascularization procedures and congestive heart failure.

About Diabetes

Diabetes affects an estimated 246 million adults worldwide and more than 53 million in Europe.(i,ii) 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.(iii)

Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(iv) 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 (50 percent of people with diabetes die of cardiovascular disease).(v) The total cost of caring for people with diabetes in Europe is estimated between 28 billion and 53 billion Euros per year.(vi)

About 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.(vii) 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 sulfonylurea, two common oral diabetes medications. Since the U.S. market introduction in June 2005, more than one million patients worldwide have been treated with exenatide.

Important Safety Information for exenatide

In clinical studies, the most common side effects were hypoglycaemia (low blood sugar) when taken with a sulfonylurea, 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 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, SYMLIN(R) (pramlintide acetate) injection and exenatide injection. 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. Further information about Amylin Pharmaceuticals is available at 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 healthcare 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 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 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 recent SEC filings 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.

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