Biodel to Submit New Drug Application for VIAject(R) to FDA

Biodel Inc. announced today its plan to submit a new drug application to the U.S. Food and Drug Administration in the second half of this year for approval to market VIAject for the treatment of diabetes. VIAject is Biodel's investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes.

Preliminary results from the Phase 3 studies were reported last year at the 44th Annual Meeting of the European Association for the Study of Diabetes . Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject that was used in the company's pivotal Phase 3 clinical trials. Biodel believes that results from both Phase 3 studies showed that VIAject was non-inferior to Humulin R, the leading recombinant human insulin, in terms of blood glucose control, when measured by the mean change in patients' hemoglobin A1c levels (HbA1c). The results also demonstrated lower incidence of hypoglycemia and less weight gain in patients receiving VIAject as compared to patients receiving Humulin R.

At the EASD conference, Biodel reported that preliminary efficacy results from patients with Type 1 diabetes in India were not comparable to results from patients in the United States and Germany. While non-inferiority of VIAject(R: 28.78, -1.0292, -3.45%) to Humulin R was achieved without the data from India, it was not achieved when the data from India was included. Biodel identified probable causes for the variance in the data from India with the assistance of regulatory consultants and presented the results to the FDA in its pre-NDA briefing package. Among the causes noted in the briefing package, an identifiable subset of blood samples from patients in India was found to be compromised due to excessive heat exposure in transit to a central laboratory. When the compromised samples are removed from the efficacy analysis, non-inferiority in both the Type 1 and Type 2 trials is achieved.

After reviewing all of the data from the two pivotal Phase 3 clinical trials with regulatory consultants and meeting with FDA staff, the company has decided to proceed with the submission of its NDA under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will review any submission the company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

Biodel's chairman and chief executive officer, Dr. Sol Steiner, stated: "After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year. This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal Phase 3 clinical trials, which we believe met the endpoint of non-inferior change in HbA1c over six months. In the meantime, we continue to collect safety data from the open-label extensions of the Phase 3 trials and are proceeding with plans to conduct additional development work this year to further differentiate VIAject from the rapid-acting insulin analogs."

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