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Biodel Awarded NIH Grant to Develop Glucagon Formulations for Use in Artificial Pancreas

Mon, 09/24/2012 - 9:41am
GLOBE NEWSWIRE

Biodel Inc. announced today that the Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel a grant for the development of novel and stable glucagon formulations for use in an artificial pancreas, also known as a closed loop pump system.

"We are pleased to receive yet another award for the advancement of our innovations designed to improve diabetes treatment therapies," said Dr. Errol De Souza, President and CEO of Biodel. "Biodel has a great deal of expertise in developing stable glucagon formulations for the treatment of severe hypoglycemia and our lead program is targeting an NDA submission in early 2014. We will leverage this expertise and concentrate the resources funded by the SBIR on utilizing our proprietary technology to produce glucagon formulations that support the development of effective artificial pancreas therapy."

The two-year grant, totaling $582,763, is intended to fund research to develop Biodel's proprietary glucagon product candidate optimized to algorithmically deliver glucagon as part of a bihormonal closed loop system to mitigate hypoglycemic events. Currently the full benefits of intensive insulin therapy for patients with diabetes have yet to be realized in large part because it is extremely difficult to optimize continuously variable insulin dose requirements using current technology and because of the inability to eliminate hypoglycemia. The use of glucagon to blunt the glucose lowering effects of excess insulin may enhance the feasibility of fully automated artificial pancreas systems, thereby minimizing the occurrence of hypoglycemia. Currently marketed formulations of glucagon are chemically and physically unstable in solution at high temperatures and are not likely to be practical for infusion through insulin pumps. Biodel will pursue a strategy to develop a stable glucagon formulation suitable for pump delivery.

This research is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number R43DK096602. This press release and all other Biodel publications associated with this grant are solely the responsibility of Biodel and do not necessarily represent the official views of the National Institutes of Health.

About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.

About The SBIR
The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs.

The mission of the SBIR program is to support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy. The program's goals are four-fold: stimulate technological innovation; meet federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from federal research and development funding.

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