LinjetaTreatment for Diabetes Type 1, Diabetes Type 2
FDA Accepts VIAject NDA for Review
FDA Accepts VIAject NDA for Review
DANBURY, Conn.--(BUSINESS WIRE)--Mar 1, 2010 - Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company's new drug application (NDA) seeking approval to market VIAject for the treatment of diabetes. VIAject is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel submitted its marketing application to the FDA on December 30, 2009 and expects the Prescription Drug User Fee Act (PDUFA) action date for this NDA to be October 30, 2010.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders such as diabetes. Biodel's product candidates are developed using VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. 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. 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, our ability to have our VIAject(R) NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject(R) and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology, particularly VIAject(R); the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of VIAject(R) for patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended December 31, 2009. 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: The Trout Group LLC
Seth D. Lewis, +1 617-583-1308
Posted: March 2010
- FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta - November 1, 2010
- Biodel Submits VIAject New Drug Application to FDA for Treatment of Diabetes - January 5, 2010
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