DANBURY, Conn., Sept. 21 /PRNewswire-FirstCall/ -- Biodel Inc. today announced that the Company has expanded its two ongoing pivotal Phase III clinical trials of VIAject(TM) into Europe. Clinical sites have been initiated in Germany and patient treatment has begun.
"We are expanding VIAject(TM)'s pivotal Phase III trials into Europe to support our planned European registration of VIAject(TM)," stated Dr. Solomon S. Steiner, Chairman and CEO of Biodel. "Given the worldwide prevalence of diabetes, we are determined to establish VIAject(TM) as a global solution. Evaluating VIAject(TM)'s therapeutic profile in European patients with Type 1 and Type 2 diabetes gives us the opportunity to demonstrate VIAject(TM)'s clinical outcomes across a more diverse patient population."
VIAject(TM) is currently undergoing two pivotal Phase III clinical studies. The two studies, one enrolling 400 Type 1 diabetic patients and the other enrolling 400 Type 2 diabetic patients, are comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin. Both studies are open label and involve a treatment regimen that is six months in duration. Clinical endpoints of both trials include non-inferiority in terms of HbA1c levels and safety.
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 product candidates are developed by using 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 trials and two osteoporosis product candidates 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 then 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 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-Q for the quarter ended June 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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