Biodel Awarded NIH Grant to Develop Concentrated Ultra-Rapid-Acting Insulin Formulations for Use in Artificial Pancreas

DANBURY, Conn., July 26, 2012 /PRNewswire/ -- 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 concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.

"We are gratified to receive this award recognizing our innovations in the development of novel therapies to treat diabetes," said Dr. Errol De Souza, President and CEO of Biodel. "These funds will be focused on applying our proprietary technology for the development of ultra-rapid-acting insulin formulations for the treatment of insulin resistant patients and to assist in the development of effective artificial pancreas therapy."

The two-year grant, totaling $582,473, is intended to fund research to develop Biodel's proprietary ultra-rapid-acting insulin product candidate at high concentrations suited to provide sufficient quantities of insulin in an external artificial pancreas pump device that has a limited volume capacity. Currently, regular insulin at concentrations of 500 units per milliliter is used to treat extremely insulin resistant patients with diabetes. While these formulations are 5-times more concentrated than typical insulin presentations, they have a prolonged duration of action that may be undesirable for use with an artificial pancreas. Concentrated formulations of Biodel's ultra-rapid-acting insulin may be absorbed more rapidly than existing concentrated insulin formulations and may therefore become an important component of an effective step in the development of an artificial pancreas.

This research is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number R43DK096604. 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; our ability advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner; 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; 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 March 31, 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.

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

SOURCE Biodel Inc.