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Study Finds Treatment with Metreleptin Improved Diabetes and Lipid Control in Patients with Partial Lipodystrophy
Date:6/4/2011

obally, approximately 150 patients with lipodystrophy are being treated with metreleptin under investigator-sponsored trials and expanded access programs.

In 2010, Amylin submitted the non-clinical and clinical sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia in patients with rare inherited or acquired forms of lipodystrophy. The Company plans to submit the chemistry, manufacturing and controls (CMC) section of the BLA by the end of this year, which will complete the application. If approved, metreleptin would be the first therapy indicated specifically for the treatment of diabetes and high triglycerides in patients with lipodystrophy, and the first approved therapeutic use of metreleptin.

About the Metreleptin Expanded Access Program

Consistent with the severity and rare nature of this disorder, Amylin has received both orphan drug designation from FDA's Office of Orphan Products Development, as well as fast track designation for use of metreleptin in patients with lipodystrophy.

Because metreleptin is not available for routine clinical use, and because of the high unmet medical need of these patients, Amylin has made this investigational medication available now under an expanded access pathway, an FDA-authorized treatment IND protocol. The treatment IND mechanism allows for access to investigational medications in special cases of unmet medical need. For more information on this program, please contact the Amylin Customer Support Center at (800) 868-1190.

About Amylin Pharmaceuticals, Inc.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN®
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SOURCE Amylin Pharmaceuticals, Inc.
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