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Amylin Pharmaceuticals to Present Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Society
Date:10/1/2008

proximately 8,000 individuals have received pramlintide in clinical trials, including more than 950 in obesity studies. Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. To date, more than 1,200 overweight or obese individuals have received metreleptin in clinical trials, several of which were 16 weeks or longer in duration.

Preclinical and clinical evidence published recently in PNAS, Proceedings of the National Academy of Sciences of the United States of America, demonstrates that, when pramlintide and metreleptin are administered in combination, leptin responsiveness is at least partially restored by amylin agonism. Experiments in diet-induced obese rats co-administrated with amylin and leptin resulted in synergistic reductions in food intake (up to 45%) and body weight (up to 15%), effects considerably greater than with leptin or amylin treatment alone. Weight loss with amylin/leptin treatment was fat- specific, and not accompanied by a reduction in lean mass. Translational clinical research confirms that findings in the non-clinical experiments are relevant to human obesity and suggest that metreleptin and pramlintide may be effective partners to pramlintide in the treatment of obesity. The most common side effects with the pramlintide/metreleptin combination treatment were injection site adverse events and nausea, which were mostly mild to moderate and transient in nature.

Important Safety Information for SYMLIN(R)

SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within three hours following a SYMLIN injection. If severe hypoglycemia occurs while
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SOURCE Amylin Pharmaceuticals, Inc.
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