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Biodel Reports Fourth Quarter and Fiscal Year 2010 Financial Results
Date:12/9/2010

nue during the fiscal years ended September 30, 2010 or 2009.

At September 30, 2010, Biodel had cash, cash equivalents, restricted cash and marketable securities of $29.1 million and 26.4 million shares of common stock outstanding.

Business Review

Since receiving a complete response letter from the U.S. Food and Drug Administration (FDA) in October regarding the NDA for Linjeta™, Biodel has requested a meeting with FDA staff to review the agency's request for new information about the drug.  Biodel plans to meet with the FDA to discuss the agency's comments in the letter and to determine how to satisfy its requests for additional information regarding the efficacy, safety and manufacture of Linjeta™.  

Biodel does not anticipate commencing new pivotal Phase 3 clinical trials with its current formulation of Linjeta™ prior to determining whether one of its other proprietary rapid-acting insulin or insulin analog formulations should be advanced in its place.  These alternate formulations generally use the same or similar excipients as Linjeta™, but may present improvements with regard to injection site discomfort.  In fiscal year 2011, Biodel intends to conduct preclinical studies and Phase 1 clinical trials to determine whether one or more of its newer insulin formulations is likely to offer a combination of pharmacokinetic, stability and tolerability characteristics that is preferable to Linjeta™.  Following its meeting with the FDA regarding Linjeta™ and based on its analysis of the preclinical and Phase 1 clinical data for its alternate formulations, Biodel will determine the number, type and duration of additional trials it will conduct prior to initiating Phase 3 clinical trials with a proprietary rapid-acting insulin.

In November at the Diabetes Technology Meeting in Bethesda, Maryland, the company reported results of a study comparing the pharmacokinetic characteri
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SOURCE Biodel Inc.
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