Exenatide Once Monthly Showed Positive Results in Phase 2 Study

BASINGSTOKE, England, March 10, 2011 /PRNewswire/ --

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycaemic control in patients with type 2 diabetes.

The 121-patient phase 2 study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. It also assessed exenatide once weekly (exenatide extended-release for injectable suspension, proposed brand name Bydureon(R)), another investigational type 2 diabetes therapy. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline. In the exenatide once-weekly treatment arm, the reduction was 1.5 percentage points. A1C is a measure of average blood sugar over three months.

More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhoea were most common among the exenatide once-weekly group. No major or minor hypoglycaemia was reported in the study.

Based on the encouraging results of this study, the companies plan to proceed with regulatory interactions to outline the next steps for this important programme.

Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in Byetta(R) (exenatide) injection, which is given twice daily. Exenatide once-monthly is based on the same Medisorb(R) microsphere technology used in exenatide once-weekly.

    
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Study Design

This phase 2, randomized, open-label study included 121 adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, pioglitazone, or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of exenatide once-weekly or subcutaneous injections of exenatide once-monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.

About Amylin, Lilly and Alkermes

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.

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

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Mass., Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.

BYDUREON(R) and BYETTA(R) are trademarks of Amylin Pharmaceuticals, Inc., and Medisorb(R) is a registered trademark of Alkermes, Inc. All other marks are the marks of their respective owners.

    
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