DANBURY, Conn., Jan. 3 /PRNewswire-FirstCall/ -- Biodel Inc. today announced that the Company has completed enrollment of its two pivotal Phase III clinical trials of VIAject(TM), a rapid-acting injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes. The Company also announced its intention to build and operate a fill and finish manufacturing facility for VIAject(TM), on the campus of its current headquarters in Danbury, Connecticut.
"We are pleased to have completed enrollment of the VIAject(TM) clinical trials on schedule," commented Solomon S. Steiner, Ph.D., Chairman and Chief Executive Officer of Biodel. "We believe that VIAject(TM)'s superior pharmacokinetic and pharmacodynamic profile should improve the treatment of millions of patients with diabetes."
Biodel has now enrolled over 400 patients with Type 1 diabetes at approximately 60 clinical sites in the United States, Europe, and Asia, and over 400 patients with Type 2 diabetes at approximately 50 clinical sites in the United States, Europe, and Asia. Both studies are multi-center, open label and six months in duration, comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin. Biodel expects to complete these trials and, if the trials are successful, the Company intends to submit a New Drug Application for VIAject(TM) to the Food and Drug Administration by the end of 2008.
To prepare for commercialization of VIAject(TM), the Company plans to build a fill and finish manufacturing facility which will be dedicated to manufacturing a full line of VIAject(TM) liquid formulations and presentations. The dedicated manufacturing facility will improve margins, provide superior quality control, and better inventory control. Biodel anticipates that the facility will cost under $15 million and will be available for commercial production in 2009.
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 and osteoporosis. Biodel's lead product candidates are all insulin formulations developed by using the VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The Company's lead product candidate, VIAject(TM), is a rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM), a sublingual tablet formulation of insulin in Phase I clinical development, and two osteoporosis product candidates, both of which are in pre-clinical studies. For further information regarding Biodel, please visit the Company's website at http://www.biodel.com/.
Safe Harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, 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 secure FDA approval for our 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; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure additional patents for VIAject(TM) and our other product candidates; 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 Quarterly Report on Form 10-K for the fiscal year ended September 30, 2007. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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