Amylin Pharmaceuticals to Present Promising New Data on the Company's Diabetes Programs at ADA 2011

SAN DIEGO, June 20, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection, and its investigational diabetes drug candidates BYDUREON™ (exenatide extended-release for injectable suspension) and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28. The Company will also host an investor presentation and webcast on Sunday, June 26 at 7:30 PM PT/10:30 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 introduce data through two oral presentations and 17 posters at the meeting. The data presented will demonstrate significant progress and new insights concerning the scientific basis and clinical utility of BYETTA, BYDUREON and SYMLIN. Additional information will be presented during a corporate symposium focused on making clinical decisions in the ever-changing environment of incretin therapies.

"We look forward to providing updates that further demonstrate the compelling safety and efficacy profiles of Amylin's approved therapies, BYETTA and SYMLIN, and our investigational candidate, BYDUREON," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals, Inc. "As one of the foremost gatherings of the diabetes community, we anticipate that the presentations and discussions at this year's ADA Scientific Sessions will showcase innovative research and treatment approaches that have the potential to transform the way diabetes is treated and improve the lives of the millions of people living with this chronic disease."

Amylin will post insights throughout the conference on its newly launched corporate blog, "Building Blocks" (www.amylinbuildingblocks.com). Building on the success of last year's Amylin ADA Online Summit, the blog will feature perspectives from Amylin leadership and global experts on key issues facing the diabetes community, and the latest innovations that could shape the future of diabetes care. New entries will be posted throughout the conference, and will continue on a regular basis after the conference concludes.

Key Amylin Abstracts Being Presented at ADA

  1. Oral: "DURATION-3: Efficacy of Exenatide Once Weekly (EQW) and Insulin Glargine QD (IG) After 84 Weeks in Patients with Type 2 Diabetes (T2D)" will be presented by Michaela Diamant, M.D. on Monday, June 27 at 9:00 AM PT.
  2. Oral: "Efficacy and Safety of Exenatide Once Weekly Versus Metformin, Pioglitazone, and Sitagliptin Used as Monotherapy in Drug-naïve Patients with Type 2 Diabetes (DUR-4)" will be presented by David Russell-Jones, M.D. on Monday, June 27 at 9:45 AM PT.
  3. Late Breaking Poster: "Safety and Efficacy of Once-Monthly Exenatide Over 20 Weeks in Patients with Type 2 Diabetes" will be presented by Leigh MacConell, Ph.D. during a poster session on Sunday, June 26 from 12:00 – 2:00 PM PT.
  4. Poster: "Exenatide Once Weekly Did Not Affect Corrected QT Interval in Patients with Type 2 Diabetes" will be presented by Philip Sager, M.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  5. Poster: "Exenatide Once Weekly: Sustained Improvement in Glycemic Control and Weight Loss Through 3 Years" will be presented by Leigh MacConell, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  6. Poster: "Efficacy and Safety of Exenatide Once Weekly Across Background Therapies: A Pooled Analysis of DURATION Studies" will be presented by James Malone, M.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  7. Poster: "The Risk of Heart Failure Among Patients Receiving Exenatide Versus Other Glucose-Lowering Medications for Type 2 Diabetes: A Matched Retrospective Cohort Analysis of the GE Healthcare Electronic Medical Record Database" will be presented by Jennie Best, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  8. Poster: "Weight Change in Placebo- and Exenatide (BID)-Treated Subjects with Type 2 Diabetes on Insulin Glargine: Effects of Sex, Diabetes Duration, Baseline A1C, and Insulin Dose" will be presented by John Buse, M.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  9. Poster: "Effects of Pramlintide in Patients with T2DM Using Larger Doses of Insulin – A Tertile Analysis Based on Daily Insulin Dose" will be presented by Kathrin Herrmann, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.
  10. Poster: "Efficacy and Safety of Adjunctive Subcutaneous Injections of Pramlintide in Patients with Type 1 Diabetes Using Insulin Pumps" will be presented by Kathrin Herrmann, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM1:30 PM PT.

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

Featured Symposium

"Incretin Therapy in Type 2 Diabetes Applied: Navigating and Making Choices in an Ever-Changing Environment." This medical education symposium will educate healthcare professionals about the differential effects within the incretin mimetic class, and when to use incretin mimetics to improve patient health outcomes. The event will be chaired by John Buse, M.D., with medical and scientific presentations by Dr. Ralph DeFronzo, M.D. and Dr. Steven Kahn, M.B., Ch.B., on Saturday, June 25 at 6:00 AM PT. This symposium is supported by an educational grant from Amylin Pharmaceuticals and Lilly USA, LLC.

Investor Presentation

Amylin will also conduct a webcast on Sunday, June 26 at 7:30 PM PT/10:30 PM ET for the investment community to review information presented at ADA. The presentation will be webcast live through the "Investors" section of Amylin's corporate website at www.amylin.com, and a recording will be made available on the website following the event. To access the live webcast, please log on to Amylin's website approximately 15 minutes prior to the presentation to register, download, and install any necessary audio software.

About SYMLIN® (pramlintide acetate) Injection

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, beta cells in the pancreas that make both insulin and amylin are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. Amylin deficiency can make it harder to control glucose levels after meals; therefore, using SYMLIN helps patients to spend more time in their normal glycemic range.  

The SymlinPen® (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®120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. The SymlinPen®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.

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 BYETTA® (exenatide) Injection

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone 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 an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not currently recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in people who have pancreatitis.

BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. See important safety information below. Additional information about BYETTA is available at www.byetta.com.

Important Safety Information for BYETTA® (exenatide) Injection

Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Consider alternative therapy if this occurs. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all 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 additional important safety information about BYETTA, please see the full Prescribing Information (www.byetta.com/pi) and Medication Guide (www.byetta.com/mg).

About 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 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 BYDUREON 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, confirm previous results, achieve intended clinical end-points and/or be predictive of real world use; risks that our preclinical studies may not be predictive; risks that our product candidates, including BYDUREON and/or exenatide once monthly, 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.

SOURCE Amylin Pharmaceuticals, Inc.



RELATED LINKS
http://www.amylin.com
http://www.symlin.com
http://www.byetta.com

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