DANBURY, Conn., Sept. 21 Biodel Inc.(Nasdaq: BIOD) today announced that the Company has expanded its two ongoingpivotal Phase III clinical trials of VIAject(TM) into Europe. Clinical siteshave been initiated in Germany and patient treatment has begun.
"We are expanding VIAject(TM)'s pivotal Phase III trials into Europe tosupport our planned European registration of VIAject(TM)," stated Dr. SolomonS. Steiner, Chairman and CEO of Biodel. "Given the worldwide prevalence ofdiabetes, we are determined to establish VIAject(TM) as a global solution.Evaluating VIAject(TM)'s therapeutic profile in European patients with Type 1and Type 2 diabetes gives us the opportunity to demonstrate VIAject(TM)'sclinical outcomes across a more diverse patient population."
VIAject(TM) is currently undergoing two pivotal Phase III clinicalstudies. The two studies, one enrolling 400 Type 1 diabetic patients and theother enrolling 400 Type 2 diabetic patients, are comparing the effects ofVIAject(TM) to Humulin(R) R, the leading recombinant human insulin. Bothstudies are open label and involve a treatment regimen that is six months induration. Clinical endpoints of both trials include non-inferiority in termsof HbA1c levels and safety.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on thedevelopment and commercialization of innovative treatments for endocrinedisorders, such as diabetes and osteoporosis. Biodel's product candidates aredeveloped by using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The Company's lead product candidate, VIAject(TM), isa rapid-acting injectable meal-time insulin in development for use by patientswith Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in twopivotal Phase III clinical trials. Biodel's pipeline also includesVIAtab(TM), a sublingual tablet formulation of insulin in Phase I clinicaltrials and two osteoporosis product candidates in pre-clinical studies. Forfurther information regarding Biodel, please visit the Company's website athttp://www.biodel.com.
This press release contains forward-looking statements within the meaningof the Private Securities Litigation Reform Act of 1995. All statements,other then statements of historical facts, including statements regarding ourstrategy, 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 toidentify forward-looking statements, although not all forward-lookingstatements contain these identifying words. The Company's forward-lookingstatements are subject to a number of known and unknown risks anduncertainties that could cause actual results, performance or achievements todiffer materially from those described or implied in the forward-lookingstatements, including, but not limited to, our ability to secure FDA approvalfor our product candidates under Section 505(b)(2) of the Federal Food, Drug,and Cosmetic Act; our ability to market, commercialize and achieve marketacceptance 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 theinterim analyses and the timing or success of our product candidates,particularly VIAject(TM) and VIAtab(TM); our ability to secure patents forVIAject(TM) and our other product candidates; our ability to protect ourintellectual property and operate our business without infringing upon theintellectual property rights of others; our estimates of future performance;our ability to enter into col