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Amylin to Present Data Showing Investigational Metreleptin Treatment Led to Long-Term Improvements in Diabetes and Lipid Control in Patients with Lipodystrophy
Date:4/15/2011

isk for serious medical problems such as acute pancreatitis, accelerated atherosclerosis, and blood vessel and nerve damage from diabetes and liver cirrhosis, which can markedly reduce quality of life and life expectancy. Metreleptin works to treat metabolic abnormalities in patients with lipodystrophy.

It is estimated that there are a few thousand patients worldwide with this condition, although robust epidemiological data are not available, as is common with rare diseases. There are no therapies currently indicated specifically for the treatment of metabolic abnormalities associated with lipodystrophy. Presently, patients may receive a combination of dietary modification, anti-diabetic medications and lipid-lowering agents. These traditional treatment approaches do not address the underlying cause of the metabolic abnormalities in lipodystrophy and are often rendered marginally effective due to the severity of the condition.

About Metreleptin for Lipodystrophy

Data from clinical studies conducted by investigators at the NIH and other academic institutions in the U.S., Europe and Japan, have demonstrated that metreleptin can have profound effects on improving insulin sensitivity, high trigylcerides, hyperglycemia and liver fat in patients with lipodystrophy who are not responsive to conventional lipid and glucose-lowering agents, even those undergoing intensive insulin therapy.

Globally, 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) se
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SOURCE Amylin Pharmaceuticals, Inc.
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