Key Developments For Biodel Inc.
Biodel Inc. (BIOD.O) (Consolidated Issue listed on NASDAQ Global Market)
Biodel Inc to Submit New Drug Application for VIAject to FDA
Biodel Inc announced its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) 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.
Biodel Inc Reports Protective Effects of VIAject Insulin On Microvascular Function in Patients with Type 2 Diabetes
Biodel Inc announced positive effects of VIAject insulin on microvascular function in patients with Type 2 diabetes which were superior to results seen with regular human insulin and insulin lispro. In the randomized cross-over pilot study, 14 patients were treated before mealtime on three days with three different insulin therapies: regular human insulin (RHI), insulin lispro (90 % of the RHI dose) and insulin VIAject (90 % of the RHI dose). The purpose of the study was to measure the effects of insulin on vascular function, as measured by biomarkers for oxidative stress and atherosclerosis, and clinical measures of tissue blood flow and tissue oxygenation. VIAject was found to be the most effective of the three insulins in improving microvasular blood flow and endothelial function and reducing postprandial oxidative stress.
Biodel Inc Announces Preliminary Results Of Pivotal Phase III Clinical Trials for VIAject
Biodel Inc announced the results from its two pivotal Phase III clinical trials designed to compare the efficacy and safety of VIAject to Humulin R, a regular human insulin (RHI), in the treatment of patients with Type 1 and Type 2 diabetes. The primary objective of the trials was to determine if VIAject is non- inferior to RHI in the management of blood glucose levels, as measured by the mean change in patients' glycosylated hemoglobin, or HbA1c, levels from baseline. HbA1c is a measure of average blood glucose level and an indication of how well patients are controlling their blood glucose. Based on the initial analyses, both clinical trials met the primary endpoint of non-inferior mean change in HbA1c over six months of treatment.
Biodel Inc Files To Sell 8.5 Million Common Shares-DJ
Dow Jones reported that Biodel Inc has filed with the Securities and Exchange Commission to sell up to 8.5 million common shares from time to time, including three million shares for selling stockholders. Biodel Inc plans to use the net proceeds from the offering for general corporate purposes, including sales and marketing expenses, clinical trial costs, research and development expenses, general and administrative expenses, and potential acquisitions.
Biodel Inc Announces Publications Demonstrating Superior Metabolic Profile Of VIAject
Biodel Inc announced the publication of positive findings from studies demonstrating the superior metabolic profile of VIAject ultra rapid-acting insulin compared to the rapid-acting analog, Humalog, and regular human insulin in healthy volunteers and compared to regular human insulin in patients with type 1 diabetes. In the Phase I glucose clamp study (Steiner et al., Diabetologia, 2008), ten healthy volunteers received subcutaneous injections of VIAject ultra rapid-acting insulin, insulin lispro (Humalog) or regular human insulin on separate days. The study showed that VIAject was absorbed and produced its metabolic effect faster than both regular human insulin and insulin lispro (Humalog) at the same dose. In a Phase II glucose clamp study (Hompesch et al., J. of Diabetes Science and Technology, July 2008), fourteen patients with type 1 diabetes were randomly assigned to receive two sequences of three subcutaneous injections of 0.1 IU/kg of VIAject or regular human insulin on separate days. Patients receiving VIAject had an earlier onset of action and shorter time to maximal plasma insulin concentration when compared to regular human insulin, confirming previous findings in healthy volunteers that VIAject is absorbed more quickly and has a more rapid onset of action and clearance than regular human insulin.
