Biodel Inc. (Nasdaq:
BIOD) 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 biodel.
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.
Biodel Inc.
biodel
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