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Biodel Reports Progress with Development of Glucose-Regulated 'Smart' Basal Insulin

Tuesday, July 13, 2010 Drug News J E 4
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DANBURY, Conn., July 12 Biodel Inc. (Nasdaq: BIOD) today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine). BIOD620 is Biodel's proprietary injectable formulation of insulin glargine that has been designed to alter its insulin release profile in response to changing glucose concentration.

Six fasted diabetic pigs received a subcutaneous injection of 0.25U/kg of BIOD620 or Lantus®. Their blood glucose was monitored every 15 minutes. Six hours after receiving their initial injection, they were fed 500 grams of food as a glucose challenge. BIOD620 was able to reduce the elevated plasma glucose levels faster than the group receiving Lantus®. Furthermore, post-meal hyperglycemia was reduced more rapidly in the BIOD620 group than in the control group.

"Current basal insulins cannot respond to conditions that affect glucose levels, such as exercise and stress, and are often administered at inappropriately high doses. This study supports the hypothesis that BIOD620 released insulin in response to changing glucose conditions and is a truly self-regulating formulation that may translate to clinically relevant conditions," Ms. Kashyap noted. "We found that BIOD620 was able to manage plasma glucose levels more rapidly than basal insulin alone. Based on these findings, which we hope to test in clinical studies, we believe that BIOD620 insulin has the potential to be a significant improvement over basal insulin currently used by patients with diabetes mellitus."

Dr. Solomon Steiner, chief scientific officer of Biodel, commented: "We are excited about these results because they suggest we have developed a new form of basal insulin that adjusts automatically to changing glucose levels."

At the same conference, Biodel also reported findings from a preclinical study exploring the effect of disodium EDTA concentration in VIAject® (ultra-rapid-acting injectable human insulin) on the drug's speed of action in diabetic pigs. EDTA is one of two key excipients used in VIAject® which affect the rapid dissociation of insulin hexamers into monomers and the subsequent rapid absorption of insulin. In a poster presentation, Dr. Roderike Pohl and colleagues from Biodel described results of a study of eight diabetic pigs showed that reduced amounts of EDTA produced lower insulin concentrations and less rapid absorption of insulin, although the duration of insulin action remained essentially the same regardless of the EDTA concentration. The authors concluded that the study demonstrated a systematic relationship between the concentration of EDTA and the speed of absorption, confirming that sufficient EDTA is required to achieve the ultra-rapid absorption profile and pharmacodynamic action of VIAject®.

Abstracts summarizing the oral presentation by Ms. Kashyap ("Smart" Basal Insulin Formulation That Releases Insulin in Response to Blood Glucose Concentrations of Diabetic Swine) and the poster presentation by Dr. Pohl (Effect of EDTA Concentration on Ultra-Rapid Action of VIAject® in Diabetic Miniature Swine) are available on Biodel's website, www.biodel.com.

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(TM) 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(TM), 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(TM) 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.

BIOD-G

Contact: Seth Lewis The Trout Group, LLC +1-646-378-2952

SOURCE Biodel Inc.
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