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Biodel Inc. Expands Ongoing Phase III VIAject(TM) Clinical Trials Into Europe
Date:9/21/2007

DANBURY, Conn., Sept. 21 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) 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 tw
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SOURCE Biodel Inc.
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