Amylin Pharmaceuticals, Inc. Release: Analysis Provides New Insights Into Use of SYMLIN® in Patients With Type 1 Diabetes Using Insulin Pumps

SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced data from a new analysis characterizing the effects of SYMLIN® (pramlintide acetate) injection in patients with type 1 diabetes who used insulin pumps during two previously completed clinical studies. The data, which will be presented during a poster presentation at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego, demonstrated that SYMLIN helped reduce A1C (a measure of average blood sugar over three months), insulin use and body weight in patients with type 1 diabetes who used insulin pumps.

"On the backdrop of continued innovation and technical advances in insulin delivery and glucose monitoring, the number of patients with type 1 diabetes who are using insulin pumps has steadily increased in recent years and is estimated to double over the next decade," said Steven Edelman, M.D., Professor of Medicine, Division of Endocrinology, Diabetes & Metabolism, University of California at San Diego and the Veterans Affairs Healthcare System of San Diego. "The findings from this analysis help us better understand the therapeutic benefit of SYMLIN as an adjunct therapy for patients with type 1 diabetes who use insulin pumps, as evidenced by reductions in A1C, insulin requirements (especially mealtime insulin) and weight. These data may provide additional insights for physicians' treatment decisions when considering other options for patients who are not achieving their targets with insulin pump use alone."

SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is produced and released by beta cells in the pancreas, the same cells that produce and release insulin. In a healthy pancreas, the two hormones work together to help stabilize blood glucose levels. SYMLIN is approved for use as an adjunct treatment in patients with diabetes who use mealtime insulin therapy (either via insulin injection or insulin pump) and have failed to achieve desired glucose control despite optimal insulin therapy.

"These data add to an already robust body of scientific evidence confirming the role of SYMLIN as an important therapeutic option for people living with type 1 diabetes," said Christian Weyer, M.D., Senior Vice President, Research and Development, Amylin Pharmaceuticals. "Confronted with well-known hurdles to achieving glycemic targets, such as fluctuating insulin requirements, postprandial hyperglycemia, weight gain, and erratic glucose swings, and despite use of modern insulin pumps, many patients are not able to manage their blood sugar levels successfully with insulin replacement therapy alone. The addition of SYMLIN to mealtime insulin may help overcome such hurdles, by helping reduce insulin requirements and stabilizing blood sugar levels so patients spend more time in the normal glucose range."

Analysis Details

This analysis evaluated the efficacy and safety of SYMLIN in a subset of patients with type 1 diabetes who used insulin pumps in two previously reported clinical studies.

In the first study, a 29-week randomized, triple-blind, placebo-controlled non-inferiority trial, insulin pump users in both the SYMLIN treatment group (n=82) and the placebo group (n=73) experienced average reductions in A1C from baseline (-0.4 percent vs. placebo -0.3 percent) at study end. At study end, SYMLIN users experienced significantly greater reductions in mealtime insulin use (-23.8 percent vs. placebo -3.2 percent). Total daily insulin use was also significantly reduced with SYMLIN (-9.0 percent) while total daily insulin increased in the placebo group (+6.8 percent). Basal insulin use with SYMLIN increased 6.9 percent, a smaller increase than that experienced by patients in the placebo group (+23.4 percent). Although not a weight loss product, SYMLIN users lost weight (-4.9 pounds) while those in the placebo group gained 3.1 pounds.

In the second study, an open-label type 1 diabetes clinical practice trial, insulin pump users who added SYMLIN to their treatment regimen for 6 months reduced A1C by 0.3 percent, mealtime insulin use by 27.5 percent, and total daily insulin use by 13.7 percent. Basal insulin use increased 0.4 percent. Additionally, patients using SYMLIN lost 7.1 pounds from baseline.

Across both studies, the adverse event profile of SYMLIN in insulin pump users was similar to that reported in previous SYMLIN trials in patients with type 1 diabetes. Hypoglycemia occurred more frequently among SYMLIN users than among those receiving placebo, and nausea was the most frequently reported adverse event.

A second poster entitled, "Effects of Pramlintide in Patients with Type 2 Diabetes Mellitus Using Larger Doses of Insulin: A Tertile Analysis Based on Daily Insulin Dose," (poster 1063-P) will also be presented by researchers at ADA.

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, 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 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. Amylin's actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including that; clinical trials or studies, including those mentioned in this press release, may not start when planned, confirm previous results, be predictive of real world use or achieve intended clinical endpoints; preclinical studies and/or the analysis mentioned in this press release, may not be predictive; our product candidates may not receive regulatory approval; SYMLIN and the SymlinPen, and the revenues generated from these products, may be affected by competition, unexpected new data, technical or safety issues, or manufacturing and supply issues. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for SYMLIN and the SymlinPen. These and additional risks and uncertainties are described more fully in Amylin'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.