Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study (1)

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Massachusetts, December 15 /PRNewswire/ --

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA(R) (exenatide) injection taken twice daily, in patients with type 2 diabetes. After 24 weeks of treatment, patients taking exenatide once weekly experienced a statistically superior reduction in HbA1c, a measure of average blood sugar over three months, of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for exenatide. Patients treated with exenatide once weekly achieved a mean HbA1c of 7.1 percent compared with a mean HbA1c of 7.7 percent in those treated with exenatide. As a secondary endpoint, both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 2.3 kilograms for patients taking exenatide once weekly and 1.4 kilograms for patients taking exenatide.

These findings are consistent with the results of other studies of exenatide once weekly and exenatide. The companies conducted DURATION-5 to support regulatory submissions outside of the U.S. and provide additional controlled clinical data on the commercially manufactured product. DURATION is a series of clinical trials designed to test the superiority of exenatide once weekly as compared to currently available type 2 diabetes medications.

"The DURATION-5 data reinforce the efficacy of exenatide and potential of exenatide once weekly in improving blood glucose control as measured by HbA1c, and build upon other successful DURATION trials," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "More importantly, results continue to suggest that if approved, exenatide once weekly could play an important role in advancing the treatment of type 2 diabetes by providing patients the opportunity for improved HbA1c control and weight loss with just one dose per week."

Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by exenatide users (35 percent). There were no major hypoglycaemic events. Cases of minor hypoglycaemia in both groups were limited to patients using background sulfonylurea therapy.

The 24-week, open-label superiority study included approximately 250 participants with type 2 diabetes who were not achieving adequate glucose control using background therapies that included diet and exercise, metformin, sulfonylurea, thiazolidinediones, or a combination of the agents. Patients were randomized to receive either exenatide once weekly or exenatide. Patients in the exenatide once weekly treatment arm received 2 milligrams once a week, while patients in the exenatide arm received 5 micrograms twice a day for the first four weeks and 10 micrograms twice a day for the remaining 20 weeks. The primary endpoint was reduction in HbA1c; secondary endpoints included change in body weight and fasting plasma glucose, safety and tolerability.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the European Medicines Agency by the end of the second quarter in 2010.

About Diabetes

It is estimated that by 2010, diabetes will affect 284.6 million adults worldwide and more than 55.4 million in Europe.(1),(2) 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.(3)

Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(4) In virtually every high-income country, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation as well as one of the leading causes of death, largely because of a markedly increased risk of coronary heart disease and stroke (cardiovascular disease).(5) In the European region, estimates indicate that at least 106 billion USD will be spent on healthcare for diabetes in 2010, accounting for 28 percent of global expenditure.(6)

About Exenatide Injection

Exenatide was the first 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.(7) 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, Lilly and Alkermes

Amylin, Lilly and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary Medisorb(R) technology for long-acting medications. Exenatide once weekly is not currently approved by any regulatory agencies.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients 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.

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 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.

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