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VIAject(R) Presentations at ADA Meeting Highlight Drug's Mechanism of Absorption and Microvascular Effects

Mon. June 08, 2009; Posted: 04:04 PM
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DANBURY, Conn., Jun 08, 2009 (BUSINESS WIRE) -- BIOD | Quote | Chart | News | PowerRating -- Biodel, Inc. (Nasdaq:BIOD) today reported new information regarding the mechanism of action of VIAject(R) (injectable prandial insulin) and an update on previously reported findings regarding the effects of VIAject(R) on microvascular function in patients with type 2 diabetes. VIAject(R) is an investigational ultra-rapid-acting injectable human insulin which Biodel is developing as a treatment for diabetes.

In a poster presentation today at the American Diabetes Association 69th Scientific Sessions, Dr. Roderike Pohl and colleagues from Biodel described results of in vitro studies to explain VIAject(R)'s mechanism of absorption and rapid onset of action (poster #438, Rapidity of Hexameric Dissociation of Various Prandial Insulin Formulations). VIAject(R) was shown to have a smaller mean particle size compared to rapid acting insulin analogs and regular human insulin. These data are consistent with an increased proportion of monomeric/dimeric insulin after injection into the subcutaneous space, a key contributor to VIAject(R)'s more rapid absorption that has been previously demonstrated in clinical studies.

In a separate presentation on Saturday, Dr. Thomas Forst and colleagues from the Institute for Clinical Research and Development (ikfe), Mainz, Germany, described results of a clinical study comparing the effect of VIAject(R) to regular human insulin and insulin lispro on markers of oxidative stress and endothelial function following a liquid test meal in patients with type 2 diabetes (poster #1304, Postprandial Vascular Effects of VIAject(R) Compared with Insulin Lispro and Regular Human Insulin in Patients with Type 2 Diabetes Mellitus). VIAject(R) was found to be the most effective of the three insulins in reducing post-prandial oxidative stress and improving microvascular blood flow and function. These findings were presented previously at the Eighth Annual Diabetes Technology Meeting in November 2008.

The two posters are available online at www.biodel.com

Dr. Solomon Steiner, chairman and chief executive officer of Biodel, stated: "These poster presentations support our belief that VIAject(R) has unique pharmacologic attributes and clinical effects which make it a very promising drug candidate for the treatment of diabetes. Our VIAject(R) characterization work demonstrated meaningful differences between VIAject(R) and other insulins which may explain its more rapid absorption profile, while measures of oxidative stress and tissue blood flow in patients receiving three different insulin therapies favored VIAject(R). These findings are encouraging and suggest to us that VIAject(R) has significant clinical and commercial potential as a treatment for diabetes.

"I also wish to congratulate our board member and good friend, Dr. Daniel Lorber, on his receipt of the ADA's Outstanding Physician Clinician in Diabetes Award today. Dr. Lorber is a well-known expert on the treatment of diabetes, a former member of the ADA board of directors, and very deserving of this prestigious honor."

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. 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 have our VIAject(R) NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject(R) 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(TM) technology, particularly VIAject(R); 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 III clinical trial of VIAject(R) for patients with Type 1 diabetes; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2009. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

SOURCE: Biodel, Inc.

The Trout Group LLC 
Seth D. Lewis, +1 617-583-1308
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