Biodel Completes Enrollment of Two Pivotal Phase III Clinical Trials of VIAject™ and Plans Manufacturing Facility for VIAject™
News Jan 08, 2008
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.
A new experimental system has been designed that can rapidly assess the pathogenic effects of a drug on a baby's developing brain. The system uses embryonic stem cells reprogrammed into neurons, and offers a powerful tool for probing genetic and molecular underpinnings of drug-induced neurodevelopmental disorders.READ MORE
An investigational drug for the treatment of sickle cell disease shows early promise in Phase 2a clinical trial. The orally administered drug, given to adult patients with sickle cell disease, is demonstrating tolerability and the ability to impact both red and white blood cell biomarkers of the disease.READ MORE
Researchers report that an experimental drug called vosoritide, allowed the average annual growth rate to increase in a study of 35 children and teenagers with a form of dwarfism. The average boost in height per year was ~6 centimeters (2.4 inches) which is close to growth rates among children of average stature.READ MORE