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Biodel Announces Phase 2 Clinical Trial Initiation Of Ultra-Rapid-Acting Insulin Candidate BIOD-123

DANBURY, Conn., Sept. 13, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today announced the initiation of a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123.  

"We are pleased to achieve another milestone in the development of BIOD-123. We continue to meet our timelines and project that we will be able to communicate top-line Phase 2 safety and efficacy data in the third calendar quarter of 2013," stated Dr. Errol De Souza, president and chief executive officer of Biodel.

Dr. Alan Krasner, Biodel's Chief Medical Officer, stated:  "This Phase 2 study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs.  There is room for improvement in the area of mealtime insulin therapy and we are hopeful that this new candidate will help usher in a new insulin class designed to achieve better meal time outcomes for patients with diabetes."

In April 2012, Biodel announced positive top-line results from a Phase 1 clinical trial of BIOD-123, which demonstrated that the formulation had a more rapid absorption than insulin lispro, sold as Humalog®, with comparable injection site tolerability.

The Phase 2 study is a randomized, open label parallel group study enrolling 130 patients with Type 1 diabetes at approximately 30 U.S. investigative centers. The patients are randomized to receive either BIOD-123 or insulin lispro as their mealtime insulin over an 18 week treatment duration. Both arms of the study use insulin glargine, sold as Lantus®, as the basal insulin. The primary endpoint compares changes in HbA1c, while secondary endpoints compare postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

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.  

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 and our liquid formulation of glucagon that is intended to treat patients experiencing severe hypoglycemia; our ability to successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; 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 or a liquid formulation of glucagon; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a liquid formulation of glucagon; 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 June 30, 2012. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.


Contact: Seth D. Lewis, +1-646-378-2952


SOURCE Biodel Inc.
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