Biodel to Provide Update on Stabilized Glucagon Program at ROTH Conference Today New Drug Application for Stabilized Liquid Glucagon submission projected in late 2013 or early 2014
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."
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.
Interested parties may access the presentation in the investor relations section of Biodel's website at www.biodel.com, which will link to a live webcast to be archived for 90 days.
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.
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 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.
CONTACT: Seth D. Lewis, +1-646-378-2952
SOURCE Biodel Inc.