EASD: New VIAject Insulin Shows Significant Reductions in Hypoglycemic Events and Weight Gain

Results from two Phase 3 Trials, demonstrate the effectiveness of this new rapid –acting insulin

Biodel Inc. reported results from its two pivotal Phase III clinical trials designed to compare the efficacy and safety of VIAject to Humulin R, a regular human insulin or RHI, in the treatment of patients with Type 1 and Type 2 diabetes, at the 44th Annual Meeting of the European Association for the Study of Diabetes in Rome.

The company stated that the primary objective of the trials was to determine if VIAject is non- inferior to RHI in the management of blood glucose levels, as measured by the mean change in patients’ glycosylated hemoglobin, or HbA1c, levels from baseline. HbA1c is a measure of average blood glucose level and an indication of how well patients are controlling their blood glucose. Based on the initial analyses, both clinical trials met the primary endpoint of non-inferior mean change in HbA1c over six months of treatment.

VIAject is Biodel’s proprietary injectable formulation of recombinant human insulin designed to be absorbed into the blood more rapidly than currently marketed rapid-acting insulin analogs.

44th Annual Meeting of the European Association for the Study of Diabetes in Rome Sept 9th, 2008