JDRF and Amylin Partner to Investigate Co-Formulating Two Hormones for Treatment of Type 1 Diabetes

NEW YORK and SAN DIEGO, May 10, 2011 /PRNewswire/ -- The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type 1 diabetes. Pramlintide, marketed by Amylin as SYMLIN® (pramlintide acetate) injection, is approved for use as an adjunct treatment in patients with diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN and insulin are currently not approved to be mixed and must be administered as separate injections.  

"Type 1 diabetes is a chronic disease that requires blood sugar testing and insulin administration multiple times a day in order to keep blood glucose levels in check. The study of this combination therapy is exciting because, if successful, it could potentially help patients achieve tighter glucose control without increasing treatment complexity," said Aaron Kowalski, Ph.D., Assistant Vice President of Treatment Therapies for JDRF. "Successfully co-formulating pramlintide and insulin could potentially help people living with type 1 diabetes to better, and more conveniently, control their disease."

In a healthy pancreas, both insulin and amylin are produced and released by the same cells. The two hormones work together to help stabilize blood glucose levels. Insulin helps the body regulate production and storage of glucose, while amylin helps control the rate at which glucose enters the blood after meals.

"People with type 1 diabetes produce neither insulin nor amylin, and with insulin replacement alone, even with intensive basal/bolus therapy, managing blood sugar becomes a daily balancing act," said Matthew Riddle, M.D., Professor of Medicine, Division of Endocrinology, Diabetes, & Clinical Nutrition, Oregon Health & Science University. "Pramlintide may provide additional benefit for these patients by stabilizing their blood sugar levels, so they spend more time in the normal glucose range."

Currently, patients who use pramlintide must separately administer their daily insulin therapy, either through injections or an insulin pump. A co-formulated therapy that harnesses the benefit of both hormones might better mimic the natural physiology of the pancreas and simplify dosing decisions.

"Ultimately, it might reduce the complexity of daily treatment for patients who are working hard to manage this disease, and improve their ability to achieve treatment goals," continued Dr. Riddle.

About the Research Collaboration

This is the second research collaboration between JDRF and Amylin to advance innovative treatments for people with type 1 diabetes. This collaboration, consisting of formulation and clinical work, will investigate whether a fixed ratio of pramlintide and insulin can effectively help treat type 1 diabetes. The formulation research will assess the feasibility of co-formulating pramlintide and insulin (both currently administered using separate injections) as a single injection. An optimal ratio of pramlintide and insulin will be identified through modeling work.  In a series of up to three clinical proof-of-concept studies, the program will also investigate the optimal pramlintide:insulin dose ratios, and determine whether delivering pramlintide and insulin in this fixed ratio, can improve glucose control and optimize treatment of type 1 diabetes compared with insulin alone.

The collaboration between JDRF and Amylin is part of JDRF's Industry Discovery and Development Partnership (IDDP) program to accelerate research that will lead to better treatments and a cure for type 1 diabetes. JDRF and Amylin are also currently collaborating on a proof-of-concept study at the UT Southwestern Medical Center to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes to determine whether it can help to decrease insulin requirements and better control glucose levels. To date, JDRF has funded 39 partnerships with 32 companies and committed approximately $73 million as part of its IDDP program.

About SYMLIN

Taken at mealtime, SYMLIN is the first and only amylin mimetic (or imitator of amylin) for use in patients with diabetes treated with mealtime 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 to make glucose control more attainable.

Healthcare professionals and patients with diabetes may obtain more information, including the complete Prescribing Information and the Medication Guide, at https://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 JDRF

JDRF is the worldwide leader for research to cure type 1 diabetes. It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.

The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump - each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.5 billion to diabetes research, including $107 million last year. More than 80 percent of JDRF's expenditures directly support research and research-related education. For more information, please visit www.jdrf.org.

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 Amylin's research with JDRF to explore whether co-formulation of insulin and pramlintide can improve blood glucose control will not produce favorable results; 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 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 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.; Juvenile Diabetes Research Foundation