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Amylin Pharmaceuticals to Present Compelling Efficacy and Safety Data From Diabetes Programs at ADA 2009
Date:5/29/2009

SAN DIEGO, May 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the company will present data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide) injection and SYMLIN(R) (pramlintide acetate) injection, and its investigational diabetes drug candidate exenatide once weekly at the American Diabetes Association's (ADA's) 69th Annual Scientific Sessions being held in New Orleans from June 5 to 9. The company will also host an investor presentation and webcast on Sunday, June 7, at 7:45 PM CT (8:45 PM ET). The annual meeting of the ADA is one of the largest scientific meetings for endocrinologists and other health care professionals involved in diabetes research and diabetes care.

Amylin will be introducing data through 16 posters and five oral presentations at the meeting. The data being presented will demonstrate significant progress in key research and clinical programs for BYETTA, exenatide once weekly and SYMLIN. Additional information will be presented during two corporate-sponsored symposia focused on the potential of peptide therapy treatment approaches for type 2 diabetes, and the role of incretin-based therapies in relation to type 2 diabetes.

"Presentations at ADA will highlight compelling efficacy and safety data for BYETTA, exenatide once weekly and SYMLIN. The data presented at ADA will further demonstrate Amylin's progress in bringing life-changing therapies to market," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals, Inc. "We look forward to this year's ADA and are pleased to have the opportunity to contribute to a body of work that is focused on improving the lives of people living with diabetes."

KEY AMYLIN ABSTRACTS BEING PRESENTED AT ADA

  1. Oral: "Exenatide Once Weekly Treatment Elicits Sustained Glycemic Control and Weight Loss Over 2 Years" will be presented by Ken Wilhelm, M.D. on Sunday, June 7 at 8:15 AM CT (9:15 AM ET).
  2. Oral: "Exenatide Once Weekly Improved Cardiometabolic Risk Factors in Subjects with Type 2 Diabetes During One Year of Treatment" will be presented by Richard Bergenstal, M.D. on Sunday, June 7 at 9:45 AM CT (10:45 AM ET).
  3. Oral: "Cardiovascular Safety of Exenatide BID: An Integrated-Analysis from Long-Term Controlled Clinical Trials in Subjects with Type 2 Diabetes" will be presented by Larry Shen, Ph.D. on Monday, June 8 at 6:15 PM CT (7:15 PM ET).
  4. Oral: "Incidence of Acute Pancreatitis in Exenatide Initiators Compared to Other Antidiabetic Drug Initiators: A Retrospective, Cohort Study" will be presented by Gary Bloomgren, M.D. on Sunday, June 7 at 8:00 AM CT (9:00 AM ET).
  5. Oral: "Comparison of Mealtime Pramlintide, Insulin or a Combination of Both, When Added to Basal Insulin Treatment in Patients with Type 2 Diabetes" will be presented by Dennis Karounos, M.D. on Saturday, June 6 at 5:30 PM CT (6:30 PM ET).
  6. Poster Late Breaker: "DURATION-2: Exenatide Once Weekly Demonstrated Superior Glycemic Control and Weight Reduction Compared to Sitagliptin or Pioglitazone after 26 Weeks of Treatment" will be presented by Richard Bergenstal, M.D., during a poster session on Saturday, June 6 from 11:30 AM - 1:30 PM CT (12:30 - 2:30 PM ET).
  7. Poster: "Safety and Tolerability of Exenatide BID in Patients With Type 2 Diabetes: Integrated Analysis of 3854 Patients From 11 Comparator Controlled Clinical Trials" will be presented by Simon Bruce, M.D. during a poster session on Saturday, June 6 from 11:30 AM - 1:30 PM CT (12:30 - 2:30 PM ET).
  8. Poster: "Clinical and Patient Reported Outcomes in Adults with Type 2 Diabetes on Basal Insulin Randomized to Addition of Mealtime Pramlintide or Rapid-Acting Insulin" will be presented by Mark Peyrot, Ph.D. during a poster session on Saturday, June 6 from 11:30 AM - 1:30 PM CT (12:30 - 2:30 PM ET).

A full list of all Amylin abstracts being presented at ADA is available at: http://scientificsessions.diabetes.org

FEATURED SYMPOSIA

  1. "Effective Use of Peptide Therapies for Optimal Glucose and Weight Control in Type 2 Diabetes." This medical education symposium will help healthcare providers understand the potential of peptide therapy treatment approaches for diabetes. The event will be chaired by David Kendall, M.D., on Saturday, June 6 at 6:00 AM CT (7:00 AM ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals.
  2. "The Clinical Relevance of Today's Incretin Therapies in the Context of the Current Algorithm." This medical education symposium will help healthcare providers understand the role of incretin-based therapies in relation to type 2 diabetes. The event will be chaired by Ralph DeFronzo, M.D. on Sunday, June 7 at 6:00 AM CT (7:00 AM ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals and Eli Lilly and Company.

INVESTOR PRESENTATION

Amylin will also conduct a webcast for the investment community to review information that will be presented at ADA. The presentation is on Sunday, June 7 at 7:45 PM CT (8:45 PM ET). The live presentation will be webcast, and a recording will be made available following the event. The webcast and recording will be accessible through Amylin's corporate Web site, located at http://www.amylin.com. To access the live webcast, please log on to Amylin's site approximately 15 minutes prior to the presentation to register and download any necessary audio software.

About SYMLIN

Taken at mealtime, SYMLIN is the first and only amylin mimetic for use in patients with diabetes treated with mealtime insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.

The SymlinPen(R) (pramlintide acetate) pen-injector is an easy way for patients to use SYMLIN and offers convenient pre-filled SYMLIN administration with simple, dial-up dosing to improve mealtime glucose control. The SymlinPen(R) 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. The SymlinPen(R) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.

Healthcare professionals and patients with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at www.SYMLIN.com.

Important Safety Information for SYMLIN

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. 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 BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control and low incidence of hypoglycemia when used with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.

Important Safety Information for BYETTA

BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For full prescribing information, visit www.BYETTA.com.

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. 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 herein due to a number of risks and uncertainties, including risks that BYETTA, SYMLIN or exenatide once weekly may be affected by competition, unexpected new data, technical or safety issues, or manufacturing and supply issues; risks that our clinical trials may not start when planned and/or confirm previous results; risks that our preclinical studies may not be predictive; risks that our product candidates may not receive regulatory approval; 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.


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SOURCE Amylin Pharmaceuticals, Inc.
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