In a successful endeavour, Biodel Inc. has completed enrolment 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 said it plans to build and operate a fill and finish manufacturing facility for VIAject, at its current headquarters in Danbury, Connecticut.
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-centre, open label and six months in duration, comparing the effects of VIAject to Humulin R, the leading 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.
"We are pleased to have completed enrolment of the VIAject clinical trials on schedule," commented Solomon S. Steiner, Ph.D., chairman and chief executive officer, Biodel. "We believe that VIAject's superior pharmacokinetic and pharmacodynamic profile should improve the treatment of millions of patients with diabetes."
The proposed manufacturing facility will improve margins, provide superior quality control, and better inventory control. Biodel anticipates that the facility will cost under $15 million and will be available for commercial production in 2009.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialisation of innovative treatments for endocrine disorders, such as diabetes and osteoporosis.