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Amylin Pharmaceuticals Highlights New Data Supporting Therapeutic Potential of Obesity Pipeline at Obesity 2009

SAN DIEGO, Calif., Oct. 19, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that new data from its obesity program will be presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, to be held in Washington, D.C. October 24-28. Phase 2 data from the pramlintide/metreleptin combination treatment clinical program will be the subject of a late-breaking oral presentation. Obesity 2009 is one of the largest scientific conferences in the field of obesity.

Amylin will also present new scientific findings from preclinical studies related to its clinical-stage obesity programs for pramlintide/metreleptin and davalintide, an optimized amylin analog. These findings include new insights into the synergistic weight loss observed with various dual-hormone combination regimens. Additionally, Amylin will present at the meeting's pre-conference session focused on obesity pharmacotherapy.

"The discovery of leptin and its role, along with other endocrine signals, in regulating body weight through a neurohormonal feedback system marked the beginning of a new era of obesity research," said Christian Weyer, M.D., vice president, Medical Development at Amylin Pharmaceuticals. "Amylin's unique approach to obesity drug development aims to translate this evolving science into innovative new treatment options and builds on over 20 years of experience in peptide-protein therapeutics."

Key Amylin Activities at Obesity 2009:

Saturday, October 24

  • Pharmacotherapy Update invited presentation: Christian Weyer, M.D., vice president, Medical Development will present at this pre-conference session scheduled from 1:00 - 3:45 p.m. ET.

Sunday, October 25

  • Poster 190-P: "Central Mechanisms Underlying Amylin/Leptin Synergy in Rodent Models" will be presented by Victoria Turek, Ph.D. at 1:00 p.m. and at 6:30 p.m. ET.
  • Poster 192-P: "Enhanced Sensitivity to Amylin-Mediated Weight Loss in Estrogen-Deficient Female Rats" will be presented by James Trevaskis, Ph.D. at 1:00 p.m. and at 6:30 p.m. ET.
  • Poster 193-P: "Impact of Sustained Amylin and/or Leptin Infusion on Energy Homeostasis, and Liver and Muscle Metabolism in Diet-Induced Obese Female Rats" will be presented by James Trevaskis, Ph.D. at 1:00 p.m. and 6:30 p.m. ET.

Tuesday, October 27

  • Oral Late-Breaking Clinical Trial Symposium: Steven R. Smith, M.D. will present during this symposium at 10:20 a.m. ET (ID 178416).
  • Poster 756-P: "Synergistic Anti-Obesity Effects of Optimized Amylinomimetic and PYY (3-36)-mimetic Peptides in Obese Rats" will be presented by Jonathan Roth, Ph.D. at noon and 5:30 p.m. ET.

A full list of Amylin abstracts being presented at Obesity 2009 will be available when the final meeting program is posted at

About Obesity

Obesity is a chronic disorder that affects millions of people and is linked to increased health risk of several medical conditions including type 2 diabetes, non-alcoholic fatty liver disease, high blood pressure, heart disease, stroke, osteoarthritis, sleep disorders and several types of cancers. According to The Obesity Society, obesity is the second leading cause of preventable death in the United States. The total direct and indirect cost burden attributed to treating overweight and obesity and related conditions has grown to nearly $150 billion in the United States each year. Obesity is also rapidly becoming a major health problem in all industrialized nations and many developing countries.

There are different classes of obesity defined by body mass index, or BMI. Overweight is defined as BMI 25 to 29.9 kg/m2, Obesity Class I is BMI 30 to 34.9 kg/m2, Obesity Class II is BMI 35 to 39.9 kg/m2 and Obesity Class III is BMI 40 kg/m2 or more. Of the over 100 million overweight and obese individuals in the United States, over 80 million have a BMI less than 35 kg/m2. It is estimated that approximately two-thirds of patients with type 2 diabetes are overweight or obese, with a BMI less than 35 kg/m2. In addition, approximately three-quarters of individuals with BMI less than 35 kg/m2 without type 2 diabetes have dyslipidemia and/or hypertension.

Amylin's Approach to Obesity Research and Development

Currently, physicians and patients seeking prescription medications for weight loss have limited therapeutic options. New scientific advances have established the key role of neurohormones in the physiological regulation of appetite and energy balance, as well as the importance of studying the interaction among these hormones (within the brain) to uncover their full therapeutic potential. Amylin scientists discovered that combination treatment with neurohormones, such as amylin and leptin, can produce additive and synergistic weight loss in animal models. These findings formed the basis for Amylin's innovative integrated neurohormonal approach to the development of obesity treatments.

About Pramlintide/Metreleptin Combination Treatment

Pramlintide acetate is a synthetic analog of the natural hormone amylin, a neurohormone secreted by the pancreas that is known to play a role in the regulation of appetite, food intake and postprandial glucose concentrations. To date, approximately 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. In 2007, results from an initial 24-week, Phase 2 clinical proof-of-concept study in 177 overweight or obese individuals (baseline BMI 27-35 kg/m2) showed that combination treatment with pramlintide/metreleptin (360 mcg/5 mg twice daily) resulted in an average weight loss of 12.7% (25 pounds) from enrollment, significantly more than treatment with pramlintide alone (360 mcg twice daily) who experienced an average weight loss of 8.4% (17 pounds) or metreleptin alone (5 mg twice daily) who experienced an average weight loss of 8.2% (16 pounds).

About Davalintide

Davalintide, a, new molecular entity being evaluated for the treatment of obesity, is an analog of the natural hormone amylin that has enhanced amylin mimetic properties. Amylin is a neurohormone secreted by the pancreas that is known to play a role in the regulation of appetite, food intake and postprandial glucose concentrations. Davalintide is currently being studied as a single agent in a six-month, Phase 2 clinical trial in overweight or obese subjects.

Amylin Pharmaceuticals

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

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company's actual results could differ materially from those discussed due to a number of risks and uncertainties, including that our obesity program may not achieve the results we expect; our clinical trials may not start when planned, be completed in a timely manner and/or confirm previous results; our preclinical studies may not be predictive; our product candidates 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 the Company's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.

SOURCE Amylin Pharmaceuticals, Inc.

SOURCE Amylin Pharmaceuticals, Inc.
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