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One Step Closer...

NEW YORK, January 13, 2010 - The Juvenile Diabetes Research Foundation today announced an innovative partnership with Animas Corporation to develop an automated system to help people with type 1 diabetes better control their disease - the first step on the path to what would be among the most revolutionary advancements in treating type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels.

Animas, a Johnson & Johnson company, is a leading manufacturer and distributor of insulin delivery and glucose management systems. JDRF is a global leader in research leading to better treatments and cures for type 1 diabetes.

The objectives of the partnership, a major industry initiative within the JDRF Artificial Pancreas Project, are to develop an automated system to manage diabetes, conduct extensive clinical trials for safety and efficacy, and submit the product to the U.S. Food and Drug Administration for approval.

"If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar," said Alan Lewis, PhD, President and Chief Executive Officer of JDRF. "Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugars within a target range. But even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating and treating themselves throughout the day."

Dr. Lewis noted that "JDRF will provide $8 million in funding over the next three years for this project, with a target of having a first-generation system ready for regulatory review within the next four or so years."

The first-generation system would be partially automated, utilizing an insulin pump connected wirelessly with a continuous glucose monitor (CGM). The CGM continuously reads glucose levels through a sensor with a hair-thin sensor wire inserted just below the skin, typically on the abdomen. The sensor would transmit those readings to the insulin pump, which delivers insulin through a small tube or patch on the body. The pump would house a sophisticated computer program that will address safety concerns during the day and night, by helping prevent hypoglycemia and extreme hyperglycemia. It would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high. For example, the system would automatically discontinue insulin delivery to help prevent hypoglycemia, and then automatically resume insulin delivery based on a specific time interval (i.e., 2 hours) and/or glucose concentration. It will also automatically increase insulin delivery to reduce the amount of time spent in the hyperglycemic range and return to a pre-set basal rate once glucose concentrations have returned to acceptable levels.

In this early version of an automated diabetes management system, the patient would still need to manually instruct the pump to deliver insulin at times, (i.e. around meals). But this "hypoglycemia-hyperglycemia minimizer" system would represent a significant step forward in diabetes management, and could provide immediate benefits in terms of blood sugar control, by minimizing dangerous highs and lows.

DexCom, Inc., a leading manufacturer of CGM devices, will supply the CGM technology for the system to be developed by JDRF and Animas.

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the immune system attacks and kills off the cells in the pancreas that produce insulin, a hormone that enables people to convert food into energy. It affects children, adolescents, and adults.

To manage their disease, people with type 1 diabetes need to measure their blood sugar multiple times throughout the day (typically by pricking a finger for a drop of blood), and inject themselves with insulin multiple times daily or use an insulin pump to keep blood sugar within a healthy range. That daily routine continues for life, because insulin does not cure diabetes.

"Although this partnership is focused on a first-generation system, not a fully automated artificial pancreas, such a system could provide better clinical outcomes for those with type 1 diabetes - reducing if not eliminating the high or low blood sugar problems that send people with diabetes to the hospital, cause accidents or injuries, and make living with diabetes so difficult," explained Aaron Kowalski, Ph.D., Assistant Vice President of for Glucose Control at JDRF and Research Director of the JDRF Artificial Pancreas Project. "And better control would significantly lower the key risk for developing the devastating long-term complications of the disease, including eye disease, kidney disease, nerve disease or cardiovascular disease."

More information about the JDRF-Animas partnership and the development of a first generation automated system to manage diabetes is available at www.jdrf.org/artificialpancreasproject. The site also includes information for people with type 1 diabetes about research leading to the development of an artificial pancreas, as well as interactive tools, chats with researchers, and access to information about clinical trials.

About JDRF

JDRF is the leader in research into a cure for type 1 diabetes and its complications. 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 eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

JDRF was founded in 1970 by parents of children with type 1 diabetes. Last year, it funded more than $100 million in diabetes research, in more than 20 countries. For more information, go to http://www.jdrf.org/.

About JDRF's Artificial Pancreas Project

The JDRF-Animas partnership will build upon the progress made since 2006 in the JDRF-funded Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts that has developed the computer programs needed for an artificial pancreas, and established their scientific feasibility. The goal of an artificial pancreas has also been embraced by the U.S. Food and Drug Administration, which along with JDRF and National Institutes of Health, brought together scientists, regulators, industry, and patients for scientific workshops on the subject in 2005 and 2008; the FDA has designated an artificial pancreas as one of its "critical path" initiatives.

Dr. Kowalski noted that the development of an artificial pancreas system is an essential step towards an ultimate cure for type 1 diabetes - a "bridge to a cure." JDRF's goal is to have multiple versions of an artificial pancreas available for people with diabetes; the organization will continue to explore partnerships with other industry leaders.

-We aren't there yet, but I will take it.

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