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Biodel's Intellectual Property Position Strengthened for Ultra-Rapid-Acting Insulin Programs by Notice of Intent to Grant from European Patent Office
Date:5/2/2012

DANBURY, Conn., May 2, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that it has received a notice of allowance from the European Patent Office for patent claims covering Biodel's ultra-rapid-acting insulin formulations intended for the treatment of patients with diabetes.  The allowed claims cover formulations containing insulin or an insulin analog as an active agent, in which hexameric insulin dissociates to monomeric or dimeric forms.  The formulations are in different forms for subcutaneous or sublingual delivery.  Method claims cover use of these formulations to treat patients with Type 1 or Type 2 diabetes by subcutaneous or sublingual delivery.  Once issued, the claims will have a term that expires in 2025—twenty years from the filing date of the previously issued parent patent.

Biodel's proprietary formulations allow insulin and insulin analogs to disassociate from the six molecule (hexameric) form to low molecular weight forms (dimeric or monomeric forms) and stabilize the low molecular weight forms, minimizing re-association to the hexameric form.  It is believed that this promotes more rapid delivery of insulin into the blood when compared to currently marketed rapid-acting insulin analogs and produces desired biological effects.

Dr. Errol De Souza, Biodel's chief executive officer, stated: "We are gratified by this additional patent coverage, which fortifies the breadth and depth of our multi-pronged ultra-rapid-acting prandial insulin programs.  These additional patents are vital to our collaboration and commercialization strategy as we progress our enhanced insulin product candidates through clinical development."

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.  We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.  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.  Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates.  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, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes; our ability advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the quarter ended December 31, 2011.  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 D. Lewis, +1-646-378-2952


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