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Published on 6/12/2006 in the Prospect News Biotech Daily.

Amylin, Lilly and Alkermes: study shows Byetta helps achieve glucose control in type 2 diabetes

By Lisa Kerner

Charlotte, N.C., June 12 - Amylin Pharmaceuticals, Inc., Eli Lilly and Co. and Alkermes, Inc. said in their collaborative study, 86% of the 45 patients with type 2 diabetes receiving the 0.8 mg dose of the once-weekly formulation of Byetta (exenatide) achieved glucose control as measured by hemoglobin A1C.

The average improvement was about 2% compared to placebo, according to a company news release.

Patients received exenatide LAR (either 0.8 mg or 2.0 mg) or a placebo for 15 weeks, followed by a 12-week safety monitoring period.

Fasting blood glucose levels were reduced by an average of 39 mg/dL in the 2.0 mg arm and 43 mg/dL in the 0.8 mg arm compared to an average increase of 18 mg/dL in the placebo group at week 15.

"In this study, the long-acting formulation of exenatide improved glycemic and weight control and was well tolerated as a combination therapy with metformin or as stand alone therapy with diet and exercise," said Dennis Kim, Amylin's senior director of medical affairs and study author, in the release.

"These early results suggest exenatide LAR can be clinically beneficial to patients with type 2 diabetes."

The three companies are working together to develop a sustained release, subcutaneous injection of exenatide based on Alkermes' proprietary Medisorb injectable long-acting release drug delivery technology.

The safety and efficacy study results were presented at the 66th Annual Scientific Sessions of the American Diabetes Association in Washington, D.C.

Amylin is a biopharmaceutical company located in San Diego.

Lilly is an Indianapolis-based pharmaceutical products company.

Located in Cambridge, Mass., Alkermes develops products based on drug delivery technologies.


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