AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Presents Results From Pramlintide Obesity Program at 14th Annual European Congress on Obesity New Dose-Ranging Study Enrolling SAN DIEGO, June 3 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) today presented detailed data from a 16-week Phase 2 obesity study of pramlintide (AC137) at the European Congress on Obesity (ECO) in Athens, Greece. Pramlintide is a synthetic analog of human amylin, a hormone known to play a role in the regulation of appetite and food intake. The study showed statistically significant, progressive weight loss of 3.6 percent (3.5 kilograms) compared to placebo, with no evidence of a plateau in effect at 16 weeks. The weight loss was accompanied by a significant, progressive reduction in waist circumference, a recognized marker of abdominal obesity and cardiovascular risk. This blinded, placebo-controlled study included 204 obese subjects, 160 without diabetes and 44 with non-insulin-treated type 2 diabetes. Study participants received pramlintide or placebo three times a day before meals for 16 weeks and were asked to maintain their usual diet and exercise routines. Subjects in this study were able to tolerate higher doses of pramlintide than those previously evaluated in long-term diabetes studies, with approximately 90% progressing to 240 micrograms three times a day. Subgroup analyses indicated that body weight reduction with pramlintide versus placebo was most pronounced in subjects with obesity class I (BMI of 30 to 35 kg/m2), who experienced an average weight loss of approximately 5 percent at 16 weeks. Pramlintide was generally well tolerated. The most common adverse event for pramlintide compared to placebo was mild, transient nausea, experienced by a minority of subjects. Weight loss in subjects who did not experience nausea was similar to that seen in those who did experience nausea. "It is clear that islet hormones can have important effects on satiety and food intake," said Jeffrey Friedman, MD, PhD, Professor, Rockefeller University and Investigator, Howard Hughes Medical Institute. Amylin submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration for the pramlintide obesity program earlier this year. The company has recently begun enrolling a 16-week Phase 2 dose-ranging study in approximately 400 obese, non-diabetic subjects. This placebo-controlled study will evaluate three doses ranging up to 360 micrograms with twice and three times a day dosing regimens. In addition to receiving either pramlintide or placebo, all subjects will participate in a lifestyle intervention program. Data from this study is expected to be available in the first half of 2006. PRAMLINTIDE ABSTRACTS BEING PRESENTED AT ECO: 1. Safety, Dose-Tolerance, and Weight-Related Effects of Pramlintide in Obese Subjects With or Without Type 2 Diabetes. C. Weyer, L. Aronne, K. Fujioka, V. Aroda, S. Edelman, K. Chen, C. Lush, Y. Wang, C. Burns, K. Lutz, S. McIntyre, J. Kornstein, M. Wintle, A. Baron. (Oral presentation) 2. Pramlintide Reduced Ad-libitum Food Intake and Meal Duration Independently of Ghrelin, PYY, CCK, and GLP-1: Further Evidence for a Physiological Role of Amylin Agonism in Human Appetite Control. C. Weyer, I. Chapman, B. Parker, S. Doran, C. Feinle-Bisset, J. Wishart, C. Lush, K. Chen, C. LaCerte, Y. Wang, C. Burns, R. McKay, M. Horowitz (Oral presentation) 3. Effect of the beta-cell hormone amylin on food intake, body weight, body composition and metabolic indicators in high fat-fed rats following cessation of treatment. C. Mack, J. Wilson, D. Parkes. (Oral presentation) 4. Effect of Amylin on Food Intake, Body Weight and Body Composition in High Fat-Fed Mice During Continuous vs. Intermittent Treatment. C. Jodka, J. Hoyt, C. Moore, D. Parkes. (Poster) About Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Further information on Amylin and its pipeline in metabolism is available at http://www.amylin.com/. Safe Harbor/Forward-Looking Statements This press release contains forward-looking statements about Amylin. The company's actual results could differ materially from those discussed in this press release due to a number of risks and uncertainties, including that current or future clinical trials, including the dose-ranging study mentioned herein, will replicate previous trial results or will conclude when planned; risks that pramlintide will not receive regulatory approval for an obesity indication and in the FDA's review process generally; risks and uncertainties inherent in the drug discovery and development process; and risks and uncertainties inherent in the company's ongoing clinical studies of pramlintide. These and additional risks and uncertainties are described more fully in the Company's recently filed Form 10-K. Amylin undertakes no duty to update these forward-looking statements. DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Alice Bahner, Executive Director, Investor Relations of Amylin Pharmaceuticals, Inc., +1-858-552-2200, ext. 7272 Web site: http://www.amylin.com/

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