SAN DIEGO, June 17, 2010 Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA® (exenatide) injection and SYMLIN® (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON(TM) (exenatide extended-release for injectable suspension) at the American Diabetes Association's (ADA's) 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29. The Company will also webcast an investor presentation on Sunday, June 27 at 7:30 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 21 posters at the meeting. The data presented will demonstrate significant progress in key research and clinical programs for BYETTA, BYDUREON and SYMLIN. Additional information will be presented during two corporate symposia.
"We are very excited to have such an active presence at this year's meeting and present compelling new data for BYETTA and SYMLIN that further demonstrate their safety and efficacy profiles," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals, Inc. "We are also sharing important data from our ongoing BYDUREON clinical program that will provide new insights about the potential of this investigational therapy in the treatment of diabetes. Our progress in each of these programs demonstrates our continued commitment to the innovative science that can help transform the lives of people living with diabetes."
For the first time, Amylin is also hosting an Online Summit focusing on perspectives from leaders within the diabetes community and information from topics that will be discussed at ADA. The summit provides a resource to help advance understanding of the key issues facing the field and viewpoints on the latest innovations and treatment strategies that will shape the future of diabetes care. The first online perspectives were posted on June 7 and will continue throughout the meeting. Additional "wrap-up" perspectives will be posted in the weeks following the conference. Content from the Online Summit is available on Amylin's corporate website at www.amylin.com.
KEY AMYLIN ABSTRACTS BEING PRESENTED AT ADA
A full list of all Amylin abstracts being presented at ADA is available at: http://scientificsessions.diabetes.org
Amylin will also conduct a webcast on Sunday, June 27 at 7:30 PM ET for the investment community to review information that will be presented at ADA. 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 website at www.amylin.com. To access the live webcast, please log on to the "Investors" section of Amylin's site approximately 15 minutes prior to the presentation to register and download 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, 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® (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 is the first FDA-approved GLP-1 receptor agonist 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 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 recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
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 April 2005 and has been used by more than one 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 post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. 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. Severe allergic reactions can happen with BYETTA.
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 and Medication Guide, at www.BYETTA.com.
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, 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.
1. Oral: "Safety and Tolerability of Exenatide Once Weekly Pooled Summary of 1095 Patients From DURATION-1, 2, and 3" will be presented by Dana Lee, PharmD on Saturday, June 26 at 9:00 AM ET. 2. Oral: "Enhanced Amylin-Mediated Weight Loss in Ovariectomized Rats is Associated With Increased Metabolism and Does Not Require Intact Leptin Signaling" will be presented by Jonathan Roth, Ph.D. on Sunday, June 27 at 5:00 PM ET. 3. Late Breaking Poster: "DURATION-5: Exenatide Once Weekly Results in Significantly Greater Improvements in Glycemic Control With Less Nausea Than Exenatide Twice Daily in Patients With Type 2 Diabetes" will be presented by Thomas C. Blevins, M.D. during a poster session on Monday, June 28 from 12:00 PM - 2:00 PM ET. 4. Late Breaking Poster: "Exenatide Added to Insulin Glargine-Treated Patients With Type 2 Diabetes Achieved Glycemic Targets and Weight Loss With No Increased Risk of Hypoglycemia" will be presented by John B. Buse, M.D., Ph.D. during a poster session on Monday, June 28 from 12:00 PM - 2:00 PM ET. 5. Poster: "A Retrospective Cohort Study to Assess the Relative Risk of Acute Pancreatitis Among Initiators of Exenatide Compared to Initiators of Other Antidiabetic Medication: A Follow-up Study" will be presented by Rebecca Noel, Dr.PH., MSPH during a poster session on Monday, June 28 from 12:00 PM - 2:00 PM ET. 6. Poster: "Three-Year Exenatide Therapy, Followed By a 4-Week Off-Drug Period, Had a Sustainable Effect on Beta-cell Disposition Index in Metformin Treated Patients With Type 2 Diabetes" will be presented by Mathijs C. Bunck, M.D. during a poster session on Monday, June 28 from 12:00 PM - 2:00 PM ET. 7. Poster: "Cardiovascular Safety of Pramlintide: A Meta-Analysis of 5 Controlled Clinical Trials in Patients With Type 2 Diabetes" will be presented by Steven Chen, M.D. during a poster session on Monday, June 28 from 12:00 PM - 2:00 PM ET.
SOURCE Amylin Pharmaceuticals, Inc.