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Biodel to Provide Update on Stabilized Glucagon Program at ROTH Conference Today
Date:3/14/2012

DANBURY, Conn., March 14, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today will provide an update on its stabilized glucagon program at the ROTH 24th Annual OC Growth Stock Conference in Laguna Niguel, California. This presentation will be webcast at 5:00 p.m. EDT (2:00 p.m. PDT).

The company recently received feedback from the FDA regarding the regulatory path forward for the development of a stabilized liquid glucagon for use as a rescue treatment for severe hypoglycemia.  Based on the FDA feedback, the company believes a New Drug Application (NDA) submission is achievable in late 2013 or early 2014.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are encouraged by the additional clarity in the feedback recently provided by the agency.  Accordingly, we will utilize the 505(b)(2) pathway and reference existing glucagon safety and efficacy data, which will allow us to significantly accelerate our development timeline, potentially enabling a commercial launch within three years."

Glucagon Rescue

Current glucagon rescue products contain cumbersome multi-component kits requiring time consuming manipulations, including liquid reconstitution of lyophilized powder, to treat a seizing or unconscious patient.  A stabilized liquid glucagon product could be packaged in one device using an auto injector and administered with relative ease similar to an EpiPen®. While less than 10% of insulin-dependent diabetics in the United States have a rescue kit, the market is over $115 million dollars per year. A more user friendly product could grow this important and underserved market.

Webcast Information

Interested parties may access the presentation in the investor relations section of Biodel's website at www.biod
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SOURCE Biodel Inc.
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