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Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
Date:4/29/2009

d for manufacturing unlabeled and unpackaged pens for the markets outside the U.S. Lilly will be responsible for labeling and final packaging of the pen product to support sales outside of the U.S. Amylin and Lilly will share sales and marketing rights in the U.S., while Lilly will be responsible for sales and marketing outside of the U.S.

"The agreement for an exenatide once weekly pen device underscores our commitment to enhance the user experience for patients with type 2 diabetes," said Vince Mihalik, senior vice president, sales and marketing, and chief commercial officer at Amylin Pharmaceuticals. "While our DURATION-1 patient questionnaire results showed that the delivery system used in clinical trials was well accepted by patients, we continue to look for ways to enhance delivery and offer patients a range of choices through alternative delivery possibilities."

Clinical Trial Initiated for New Exenatide Once Weekly Suspension Formulation

Exenatide once weekly suspension is an investigational formulation that eliminates the need to reconstitute the product prior to use. The companies have initiated a phase 1/2 clinical trial designed to evaluate the pharmacokinetics, tolerability and safety of this new exenatide once weekly formulation in both healthy volunteers and people with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. The trial began this month and initial findings are expected by the end of 2009.

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

About Diabetes

Diabetes affects more than 23 million people i
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SOURCE Amylin Pharmaceuticals, Inc.
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