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

DANBURY, Conn., Sept. 24, 2012 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) 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.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes and our liquid formulation of glucagon that is intended to treat patients experiencing severe hypoglycemia; our ability to successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin or a liquid formulation of glucagon; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a liquid formulation of glucagon; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the quarter ended June 30, 2012. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

BIOD-G

CONTACT: Seth D. Lewis, +1-646-378-2952
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