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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

SAN DIEGO, April 15, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced results from a new analysis of an ongoing, long-term research study of the investigational drug metreleptin, an analog of the human hormone leptin, for the treatment of lipodystrophy. The study is being conducted by investigators from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Results from the analysis will be presented by Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals, at a late-breaking oral session on Sunday, April 17 at 7:55 a.m. PT at the 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) in San Diego.

In the study, which has been ongoing for more than 10 years, researchers at the NIH are examining the effect of metreleptin on several metabolic abnormalities, including diabetes and hypertriglyceridemia (high levels of triglycerides in the bloodstream), in patients with rare inherited or acquired forms of lipodystrophy. Treatment with metreleptin resulted in robust reductions from baseline in both A1C and triglycerides. (A1C is a measure of average blood sugar over three months; triglycerides are the major form of fat stored in the body.) These improvements were apparent at four months and generally sustained for up to several years of treatment.

"Patients with rare forms of lipodystrophy are often affected by the disease early in life, are at high risk of acute and chronic complications and, currently, have very limited therapeutic options," said Dr. Weyer. "The results of our analysis reaffirm the potential of metreleptin as an important advance for people living with this chronic and often debilitating metabolic disease. We continue to work diligently toward bringing this potential therapy to market."

Study Findings

The findings involve an analysis of 55 lipodystrophy patients who received metreleptin treatment – the largest lipodystrophy cohort reported to date. At baseline, 75 percent of patients had diabetes and were not achieving adequate glycemic control (A1C greater than or equal to 7 percent), and 75 percent of patients had hypertriglyceridemia (triglycerides greater than or equal to 200 mg/dL). Metreleptin treatment resulted in robust reductions from baseline in both measures, an effect that was evident within four months post treatment initiation and sustained for up to several years of treatment. In patients with diabetes, mean A1C decreased from 9.4 percent at baseline to under 7.0 percent at year three; in patients with hypertriglyceridemia at baseline, median triglyceride concentrations decreased from 500 mg/dL at baseline to under 200 mg/dL at year three.

Adverse events were generally consistent with known co-morbid conditions of lipodystrophy (pancreatitis, proteinuria, autoimmune/chronic hepatitis) or expected pharmacological effects of metreleptin (weight loss or insulin-induced hypoglycemia in the setting of improved insulin sensitivity in patients on high doses of insulin).

About Lipodystrophy

Lipodystrophy syndromes are characterized by abnormalities in adipose (fat) tissue distribution. Because patients with lipodystrophy do not have enough fat tissue, they typically also have a deficiency of leptin, a hormone secreted by fat cells that plays a key role in regulating metabolism. Beginning typically in childhood or adolescence, patients affected by lipodystrophy experience a loss of subcutaneous fat, which can result in multiple, often severe metabolic abnormalities, including extreme insulin resistance, very high triglyceride levels, difficult-to-control diabetes and hepatic steatosis (excess fat accumulation in the liver). These abnormalities put patients at a high risk 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) 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 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® (pramlintide acetate) injection and BYETTA® (exenatide) injection. 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, California. Further information on Amylin Pharmaceuticals is available at www.amylin.com.

This press release contains forward-looking statements about Amylin which involve risks and uncertainties.  The actual results for Amylin could differ materially from those discussed due to a number of risks and uncertainties, including that the CMC section of the metreleptin BLA mentioned in this press release may not be submitted in a timely fashion, the estimate of the number of lipodystrophy patients mentioned in this press release may not be accurate, clinical trials or studies may not start when planned, confirm previous results, be predictive of real world use or achieve intended clinical endpoints; preclinical studies may not be predictive; our product candidates, including the product candidate mentioned in this press release, may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process. These and additional risks and uncertainties are described more fully in Amylin's most recently filed SEC documents, including its Annual Report on Form 10-K. Amylin undertakes no duty to update these forward-looking statements.


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SOURCE Amylin Pharmaceuticals, Inc.
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