Biodel Announces Research Grants by Juvenile Diabetes Research Foundation to Evaluate Use of VIAject® in Treatment of Diabetes

DANBURY, Conn., July 12 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) announced today the award of two research grants by the Juvenile Diabetes Research Foundation (www.jdrf.org) to Stanford University and Oregon Health & Science University (OHSU) to evaluate the use of VIAject® (ultra-rapid-acting injectable human insulin) in the treatment of diabetes.  The first grant will support clinical testing under the direction of Bruce Buckingham, M.D., professor of pediatrics at Stanford University School of Medicine, to compare the effects of VIAject® and Humalog® (insulin lispro) on postprandial glycemia when used with insulin pumps.  The second grant will support clinical testing at OHSU under the direction of W. Kenneth Ward, M.D., associate professor at OHSU, to evaluate the use of VIAject® to improve closed-loop, (artificial pancreas) glycemic control in patients with Type 1 diabetes.  Biodel will supply VIAject® to these institutions which will receive a total of approximately $407,000 from JDRF to fund the two research projects over the next year.

Dr. Alan Krasner, Biodel's chief medical officer, stated: "The goal of these projects is to evaluate whether an ultra-rapid-acting insulin can safely improve glycemic control for Type 1 patients and do so with less direct medical supervision.  We are pleased to be working with leading endocrinologists at Stanford and OHSU on this research and thank JDRF for its support of these important studies."  

Dr. Ward stated: "Despite advances in insulin delivery and formulation, currently available insulins do not adequately mimic the first-phase insulin release needed to provide proper meal-time glycemic control for patients with Type 1 diabetes.  We look forward to evaluating Biodel's more-rapid-acting injectable human insulin in a closed-loop setting to see whether we can achieve better post-prandial glycemic control for these patients."

VIAject® is Biodel's proprietary ultra-rapid-acting formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.  It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India.  Biodel has submitted an application to the U.S. Food and Drug Administration for clearance to market VIAject® for the treatment of diabetes.

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes.  Biodel's product candidates are developed using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs.  Biodel's new drug application for its most advanced product candidate, VIAject®, has been accepted for review by the FDA with a Prescription Drug User Fee Act action date of October 30, 2010.  Earlier-stage product candidates include VIAtab™, a sublingual tablet formulation of insulin, a line of basal insulins, and a stabilized formulation of glucagon.  For further information regarding Biodel, please visit the company's website at www.biodel.com.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, our ability to secure FDA approval for VIAject® and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology, particularly VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of VIAject® for patients with Type 1 diabetes; the possibility that patients taking VIAject® may experience more injection site discomfort than they experience with competing products; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended March 31, 2010.  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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SOURCE Biodel Inc.