Amylin Pharmaceuticals to Present Promising Data From Diabetes and Obesity Programs at ADA 2008
SAN DIEGO, June 02, 2008 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today announced that the company will present new data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide) injection and SYMLIN(R) (pramlintide acetate) injection, and its pipeline diabetes and obesity drug candidates at the American Diabetes Association's 68th Annual Scientific Sessions (ADA) being held in San Francisco, CA from June 6 to 10. The company will also host an investor presentation on Sunday, June 8, at 7:45 PM PT (10:45 PM ET) that will be available by webcast. ADA is one of the largest scientific meetings for endocrinologists and other health care professionals involved in diabetes research and the delivery of diabetes care.
Amylin will be introducing data through over 20 posters and eight oral presentations at the meeting. The data will demonstrate significant progress in key research and clinical programs that include studies of BYETTA, SYMLIN, and Amylin's early and late-stage pipeline candidates. Additional information will be presented during two symposia focused on the multi-hormonal approach to the treatment of diabetes and obesity, and the role of incretin-based therapies in type 2 diabetes.
"We are excited to demonstrate advancement in our diabetes and obesity pipeline programs at this year's ADA, particularly with updated data related to the once-weekly formulation of exenatide and the combination therapy program for obesity," said Daniel M. Bradbury, President and Chief Executive Officer, Amylin Pharmaceuticals, Inc. "At Amylin, we continually strive toward our mission of Challenging Science and Changing Lives. By challenging science we question conventional thinking, and open the door for truly innovative approaches for developing novel, life-changing therapies. This unique approach, paired with our deep expertise in peptide hormones and broad experience in diabetes markets, has allowed us to continue developing important medicines with life-changing therapeutic potential for patients."
KEY AMYLIN ABSTRACTS BEING PRESENTED AT ADA Diabetes 1. Oral Late Breaker: "Exenatide Once Weekly Elicits Sustained Glycemic Control and Weight Loss Over 52 Weeks" will be presented by John B. Buse, M.D., Ph.D., on Monday, June 9 at 5:50 PM PT (8:50 PM ET). 2. Oral: "Exenatide Once Weekly Results in Significantly Greater Improvements in Glycemic Control Compared to Exenatide Twice Daily in Patients with Type 2 Diabetes" will be presented by Daniel Drucker, M.D. on Saturday, June 7 at 9:00 AM PT (12:00 PM ET). 3. Poster: "Exenatide Monotherapy Improves Glycemic Control and is Well Tolerated Over 24 Weeks in Drug-Naive Patients with Type 2 Diabetes" will be presented by Robert Brodows, M.D. during a poster session on Sunday, June 8 from 12:00 - 2:00 PM PT (3:00 - 5:00 PM ET). 4. Oral Late Breaker: "Pramlintide or Mealtime Insulin Added to Basal Insulin Treatment in Patients with Type 2 Diabetes" will be presented by Matthew Riddle, M.D. on Monday, June 9 at 4:30 PM PT (7:30 PM ET). Obesity 1. Poster: "Enhanced Weight Loss Following Pramlintide/Metreleptin Combination Treatment in Obese Subjects: Clinical Evidence for Restoration of Leptin Responsiveness by Amylin Agonism" will be presented by Christian Weyer, M.D. during a poster session on Monday, June 9 from 12:00 - 2:00 PM PT (3:00 - 5:00 PM ET). 2. Oral: "Enhanced Weight Loss Following Co-Administration of Pramlintide with Sibutramine or Phentermine in Obese Subjects" will be presented by Louis Aronne, M.D. on Saturday, June 7 at 5:00 PM PT (8:00 PM ET). 3. Oral: "Triple Peptide Administration of Amylin, Leptin and PYY (3-36) in Diet-Induced Obese Rats: Magnitude and Mechanism of Weight Loss" will be presented by James Trevaskis, M.D. on Sunday, June 8 at 3:15 PM PT (6:15 PM ET).
A full list of all Amylin abstracts being presented at ADA is available at: http://scientificsessions.diabetes.org.
FEATURED SYMPOSIA 1. "Multi-Hormonal Treatment Approaches and the Diabetes-Obesity Continuum." Building upon the success of last year's symposium, this medical education symposium will help healthcare providers understand the potential of multi-hormonal treatment approaches for diabetes and obesity. The event will be chaired by Carol Hatch Wysham, M.D., FACP, FACE on Saturday, June 7 at 6:00 AM PT (9:00 AM ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals. 2. "Transformation of the Type 2 Diabetes Algorithm: The Incretin Effect." 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 8 at 6:00 AM PT (9:00 AM ET). This symposium is supported by an unrestricted educational grant from Amylin Pharmaceuticals and Eli Lilly and Company.
Amylin will also conduct a webcast for investors to review the information presented at ADA on Sunday, June 8 at 7:45 PM PT (10:45 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.
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.
SymlinPen(R) (pramlintide acetate) pen-injector devices offer convenient pre-filled SYMLIN administration with simple, fixed dosing to improve mealtime glucose control. SymlinPen(R) 120 features fixed dosing to deliver 60 or 120 micrograms of SYMLIN per dose. SymlinPen(R) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
Healthcare professionals and people with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at http://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.
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, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. BYETTA was approved in April 2005 and has been used by approximately one million patients since its introduction. For full prescribing information, visit http://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 most common 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 http://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 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.
CONTACT: media, Alice Izzo of Amylin, +1-858-642-7272, cell,+1-858-232-9072, ; or Rachel Martin of Edelman,+1-323-202-1031, cell, +1-323-373-5556, ; orinvestors, Michael York of Amylin, +1-858-458-8602, cell, +1-858-349-8118, email@example.com firstname.lastname@example.org email@example.com
Ticker Symbol: (NASDAQ-NMS:AMLN)
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Posted: June 2008