Biodel submits NDA to FDA for clearance to market VIAject

Dec 30 2009

Biodel, Inc. (Nasdaq: BIOD) announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes. VIAject® is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel’s most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel is seeking approval to market VIAject® in the United States as a 100 IU/cc, pH7 (neutral) injectable liquid, in 10 ml vials and 3 ml pen cartridges.

The NDA includes results from pharmacokinetic, pharmacodynamic and standardized meal studies, two pivotal 6-month Phase 3 clinical trials of VIAject® in patients with Type 1 and Type 2 diabetes, as well as interim results from the long-term, 18-month safety extension trials for patients who completed the pivotal Phase 3 clinical trials. The data from these studies consistently document the safety and efficacy of VIAject®.

Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated: “We believe our studies demonstrate that patients receiving VIAject® had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin, and that VIAject® may offer important clinical benefits to people with diabetes. I congratulate our team on submitting the NDA and reaching this important milestone in the development of our lead product candidate.”