SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. today announced that new data for its pipeline obesity candidates will be presented at the 2008 Annual Scientific Meeting of The Obesity Society in Phoenix October 3-7. The Obesity Society’s annual meeting is one of the largest and most comprehensive scientific conferences in the field of obesity.
Amylin will present scientific data through 11 oral and poster presentations, showcasing progress in the company’s obesity pipeline. In addition to Amylin’s lead clinical-stage programs in obesity, pramlintide/metreleptin and AC2307, new findings will also be presented on various preclinical programs, including a new Y-family mimetic and Amylin’s peptide hybrid (phybrid) platform. Additional information will be presented during two corporate-sponsored symposia focused on the emerging peptide hormone approach to the treatment of obesity and the new science and therapeutic research that shows promise to reduce the risk of cardiovascular disease associated with obesity and type 2 diabetes.
“We are excited to present our latest work on the obesity front at this year’s Obesity Society meeting, and will be sharing compelling data that demonstrates how our programs have the potential to provide significant weight loss that can be sustained over time,” said Daniel Bradbury, president and chief executive officer at Amylin Pharmaceuticals, Inc. “Our unique neurohormonal approach to obesity, and our deep expertise in peptide hormones, enables us to develop drugs that may help regulate how many calories we eat, burn and store as fat by mimicking the effects of naturally occurring hormones. Amylin’s approach has the potential to achieve significant weight loss with a reduced risk for side effects that are often seen with other obesity treatments.”
KEY AMYLIN ACTIVITIES AT THE OBESITY SOCIETY MEETING 1. Invited symposium presentation: "Therapeutic Potential of Leptin in General Obesity: A New, Integrated Neurohormonal Approach" will be presented by Christian Weyer, MD, Vice President, Corporate Development for Diabetes and Obesity at Amylin Pharmaceuticals, Inc., as part of a symposium entitled "Leptin: From Bench to Bedside" on Sunday, October 5 from 3:45-5:30 p.m. PT (6:45 p.m. ET). This symposium is part of the conference's core scientific program. 2. Oral 64-OR: "Enhanced weight loss following pramlintide/metreleptin combination treatment in overweight and obese subjects is accompanied by improved control of eating" will be presented by Steve Smith, MD, Sunday, October 5 at 11:45 a.m. PT (2:45 p.m. ET). 3. Poster 323-P: "Safety of 360 ug pramlintide BID treatment for up to 2 years" will be presented by Nicole Kesty, PhD, Saturday, October 4 at 5 p.m. PT (8 p.m. ET). 4. Poster 592-P: "Changes in weight and binge eating scale scores in obese subjects treated with pramlintide as monotherapy and in combination with oral weight loss agents" will be presented by Fulton Velez, MD, Sunday, October 5 at 5:30 p.m. PT (8:30 p.m. ET). 5. Poster 205-P: "Effects of amylin/leptin lead-in on the weight-reducing effects of amylin and/or leptin in diet-induced obese (DIO) rats" will be presented by Chunli Lei, Saturday, October 4 at 5 p.m. PT (8 p.m. ET). 6. Poster 651-P: "AC2307, an amylin mimetic, reduced 24-h food intake in obese subjects without changing subjective perceptions of hunger and fullness" will be presented by Nico Pannacciulli, MD, PhD, Sunday, October 5 at 5:30 p.m. PT (8:30 p.m. ET). 7. Poster 489-P: "Central activation and weight-lowering actions of AC164209, a peptide hybrid linking a glucagon-like peptide-1 (GLP-1) receptor agonist and an amylin mimetic" will be presented by Christine Mack, PhD, Sunday, October 5 at 5:30 p.m. PT (8:30 p.m. ET). 8. Corporate-sponsored symposium: "Emerging Peptide Hormone Therapies for the Treatment of Obesity: Mechanisms of Action, Clinical Safety and Efficacy." This medical educational symposium will help healthcare providers understand the peptide hormone approach to the treatment of obesity. The event will be chaired by George A. Bray, MD, MACP, Saturday, October 4 at 7:15 p.m. PT (10:15 p.m. ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals. 9. Corporate-sponsored symposium: "Reducing CVD Risk: Emerging Science and Therapeutic Options in the Management of Obesity and Type 2 Diabetes." This medical education symposium will help healthcare providers understand new science and therapeutic options to reducing cardiovascular disease risk in the treatment of obesity and type 2 diabetes. The event will be chaired by Robert H. Eckel, MD, Monday, October 6 at 5:45 p.m. PT (8:45 p.m. ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals and Eli Lilly and Company.
A full list of all Amylin abstracts being presented at the 2008 Obesity Society meeting is available at: http://www.obesity.org/annualmeeting08/OS_Phoenix08_Final_Program.pdf .
Obesity is a chronic disease 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/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. 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 and who have failed to achieve desired glucose control despite optimal insulin therapy. Since launch, over 110,000 patients have been treated with SYMLIN. 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.
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 operating a motor vehicle, heavy machinery, or while engaging in other high- risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. This information is highlighted in a boxed warning in the SYMLIN prescribing information for healthcare professionals and in a medication guide for patients, which will be distributed by pharmacists.
Other adverse events commonly observed with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported adverse event. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually increased to the recommended doses.
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, 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 2,000 employees nationwide. Further information on Amylin Pharmaceuticals is available at http://www.amylin.com/.
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.
Amylin Pharmaceuticals, Inc.
CONTACT: Alice Izzo of Amylin Pharmaceuticals, +1-858-642-7272, Cell,+1-858-232-9072, [email protected]; or Rachel Martin of Edelman,+1-323-202-1031, Cell, +1-323-373-5556, [email protected], for AmylinPharmaceuticals
Web site: http://www.amylin.com/