Biodel Inc. has announced that the Company has completed enrollment of its two pivotal Phase III clinical trials of VIAject™, a rapid-acting injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes.
The Company also announced its intention to build and operate a fill and finish manufacturing facility for VIAject™, on the campus of its current headquarters in Danbury, Connecticut.
"We are pleased to have completed enrollment of the VIAject™ clinical trials on schedule," commented Solomon S. Steiner, Ph.D., Chairman and Chief Executive Officer of Biodel.
"We believe that VIAject™'s superior pharmacokinetic and pharmacodynamic profile should improve the treatment of millions of patients with diabetes."
Biodel has now enrolled over 400 patients with Type 1 diabetes at approximately 60 clinical sites in the United States, Europe, and Asia, and over 400 patients with Type 2 diabetes at approximately 50 clinical sites in the United States, Europe, and Asia.
Both studies are multi-center, open label and six months in duration, comparing the effects of VIAject™ to Humulin® R, a recombinant human insulin. Biodel expects to complete these trials and, if the trials are successful, the Company intends to submit a New Drug Application for VIAject™ to the Food and Drug Administration by the end of 2008.
To prepare for commercialization of VIAject™, the Company plans to build a fill and finish manufacturing facility which will be dedicated to manufacturing a full line of VIAject™ liquid formulations and presentations.
Biodel anticipates that the facility will cost under $15 million and will be available for commercial production in 2009.