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Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity

Preclinical findings of amylin/leptin synergy and translational Phase 2A clinical results published online today in Proceedings of the National

Academy of Sciences of the United States of America

SAN DIEGO, May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced the initiation of a Phase 2B clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of obesity. The objective of this dose-ranging study is to support dose selection for Phase 3, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.

"There is a tremendous medical need and market demand for a weight loss product that meets both safety and efficacy expectations of patients and physicians, and we believe that our integrated neurohormonal approach to obesity holds great promise for achieving this profile," stated Christian Weyer, M.D., Vice President of Clinical Research, Amylin Pharmaceuticals. "Building upon the positive results of our translational research program published today in PNAS, and the extensive clinical experience with both pramlintide and metreleptin as monotherapies, the newly initiated Phase 2B study will bring us one step closer to our goal of offering obese individuals a safe and effective therapy that results in meaningful weight loss."

The Phase 2B study will include a broad range of overweight and obese subjects (body mass index 27 to 45 kg/m2) and will compare various pramlintide/metreleptin combination regimens with each compound alone and with placebo.

PNAS Publication

Also today, comprehensive preclinical findings of amylin/leptin synergy, along with positive results of a translational Phase 2A clinical study were published online in PNAS, Proceedings of the National Academy of Sciences of the United States of America, in a scientific paper entitled, "Leptin Responsiveness Restored by Amylin Agonism in Diet-Induced Obesity: Evidence from Non-Clinical and Clinical Studies."

"Leptin is a fundamentally important hormone in energy metabolism with a unique role in inducing fat-specific weight loss and in preventing weight loss counterregulation," remarked Steven Smith, M.D., Professor and Assistant Associate Director of Clinical Research, Endocrinology Laboratory at the Pennington Biomedical Research Center. "The intriguing and important findings published today constitute a strong scientific basis for the development of peptide hormone combinations, and provide renewed hope of harnessing the therapeutic potential of leptin as part of an integrated neurohormonal approach to obesity pharmacotherapy."

The scientific studies included in the PNAS publication provide preclinical and clinical evidence that leptin responsiveness is at least partially restored by amylin agonism. In several independent experiments in diet-induced obese rats, co-administration of amylin, together with 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. Importantly, weight loss with amylin/leptin treatment was fat-specific, and not accompanied by a reduction in lean mass. Neurohistological studies provided important insights into the neurobiological basis of amylin/leptin synergy. Finally, the translational clinical research confirmed that findings in the non-clinical experiments are relevant to human obesity and suggest that metreleptin may be an effective partner to pramlintide in the treatment of obesity.

The full paper, published in the May 5, 2008 early edition of PNAS, is available online at PNAS is one of the world's most prestigious multidisciplinary scientific journals.

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, 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 attributed to overweight and obesity health issues exceeds $100 billion in the United States each year. Obesity is also rapidly becoming a major health problem in all industrialized nations and many developing countries.

Amylin's Approach to Obesity Research and Development

Physicians and patients seeking prescription medications for weight loss have limited therapeutic options. New scientific advances have established the key role of neurohormones in regulating 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 and Metreleptin

Pramlintide is a synthetic analog of 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. Pramlintide is the active ingredient in SYMLIN(R) (pramlintide acetate) injection, which is indicated for use by patients with type 1 and type 2 diabetes who use mealtime insulin. Since launch, over 80,000 patients have been exposed to SYMLIN. To date, more than 6,000 individuals have received pramlintide in clinical trials, including more than 800 in obesity studies. In previous clinical studies, obese subjects treated with pramlintide 360 micrograms twice daily for 1 year experienced an average weight loss of approximately 8 percent from baseline compared with a 1 percent weight loss in patients receiving placebo. The most common side effect observed with pramlintide treatment in previous obesity studies was mild, transient nausea.

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. Amylin acquired exclusive rights to the leptin molecular franchise and clinical program in 2006. To date, more than 1,000 individuals have received metreleptin in clinical trials, several hundred of which were obese and treated for 16 weeks or more. In multiple previous human clinical trials with metreleptin treatment alone, minimal weight loss was observed. This observation is consistent with findings in diet-induced obese rats, and suggests the presence of leptin resistance. In contrast, and consistent with findings in ob/ob (leptin deficient) mice, long-term treatment with metreleptin has been shown to elicit profound, fat-specific weight loss in severely obese individuals who are rendered leptin deficient by rare genetic mutations of the leptin gene. The most common side effect observed with metreleptin treatment in previous obesity studies was injection site adverse events.

About Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (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 with over 1,900 employees nationwide. 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 clinical trials may not start when planned 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.
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