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Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
Date:7/16/2008

DANBURY, Conn., July 16 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today announced that its two pivotal Phase III VIAject(TM) clinical trials are now complete, with the last study patient visit on July 14, 2008. Results of the full trial will be released either at Biodel's poster presentation at the European Association for the Study of Diabetes (EASD) on Tuesday, September 9, 2008, or at a later appropriate scientific forum.

Biodel also announced that two abstracts containing interim data from its VIAject(TM) Phase III clinical trials was posted on the Website for the 44th Annual Meeting of the EASD. The abstracts disclosed results of a January 2008 preliminary interim analysis of the secondary endpoints of dose, weight, and mild and moderate hypoglycemic events for the VIAject(TM) Phase III clinical trials.

"We continue to meet our timelines and are encouraged by the VIAject(TM) Phase III interim data, which continues to meet our expectations," stated Dr. Solomon Steiner, Chief Executive Officer and Chairman of Biodel. "We look forward to performing our final analysis and presenting data from the completed studies after the clinical trial database has been locked."

The interim analysis, dose and weight changes after six weeks of drug treatment were compared to the baseline for all patients who had completed six weeks or more of treatment. Additionally, total mild and moderate hypoglycemic events as of January 2008 were compared across the two treatment arms. The following additional information was reported in the EASD abstracts:

The interim results demonstrated statistically significant differences in weight changes in patients with Type 1 and Type 2 diabetes using VIAject(TM) compared to Humulin(R) R in the first six weeks of the study. Type 1 patients (n=102) receiving VIAject(TM) showed no change in weight compared to baseline, while a weight gain (1.4 +/- 2.9 kg) was seen in the patients (n=108) receiving Humulin(R
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SOURCE Biodel Inc.
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