Key Developments: Biodel Inc. (BIOD.O)
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Latest Key Developments
Biodel Inc Submits VIAject New Drug Application To FDA For Treatment Of Diabetes
Biodel Inc announced 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 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.
Biodel Inc Announces Completion of Two Pivotal Trials
Biodel Inc announced that its two pivotal Phase III VIAject clinical trials are now complete, with the last study patient visit on July 14, 2008. Results of the full trial will be released either at Biodel's poster presentation at the European Association for the Study of Diabetes (EASD) on September 9, 2008, or at a later appropriate scientific forum. Biodel also announced that two abstracts containing interim data from its VIAject Phase III clinical trials was posted on the Website for the 44th Annual Meeting of the EASD. The abstracts disclosed results of a January 2008 preliminary interim analysis of the secondary endpoints of dose, weight, and mild and moderate hypoglycemic events for the VIAject Phase III clinical trials.
Biodel Inc Announces Pricing Of Public Offering
Biodel Inc announced the pricing of the underwritten public offering of 3,810,000 shares of its common stock at a price to the public of $15.50 per share. Of the shares being sold in the offering, 3,260,000 shares are being issued and sold by the Company and 550,000 shares are being sold by certain stockholders of the Company. The Company expects to receive net proceeds from the offering of approximately $46.4 million, after deducting underwriting discounts and commissions, and estimated offering expenses. The Company will not receive any proceeds from the sale of shares by the selling stockholders. In addition, the selling stockholders have granted the underwriters a 30 day option to purchase up to an additional 571,500 shares of common stock to cover over-allotments, if any. Morgan Stanley & Co. Incorporated is acting as the sole book-runner manager and J.P. Morgan Securities Inc. is acting as co-lead manager for this offering. Leerink Swann LLC and Natixis Bleichroeder Inc. are acting as co-managers.
Biodel Inc Files To Offer 3.8 Million Shares-Reuters
Reuters reported that Biodel Inc has filed with the U.S. Securities and Exchange Commission to sell 3.8 million shares of its common stock. The Company is offering 3.26 million shares and 550,000 shares by certain selling stockholders. The selling stockholders have granted the underwriters the right to purchase up to an additional 571,500 shares of Biodel's shares to cover over-allotments. Net proceeds from the sale of shares by the Company, expected to fetch about $70.9 million, will be used to fund clinical development of certain formulations and clinical trials, and other purposes.
Biodel Inc Announces Appointment Of Gerard Michel As CFO
Biodel Inc announced that Gerard Michel has been appointed as the Company's Chief Financial Officer (CFO), Vice President of Corporate Development and Treasurer, effective November 20, 2007. The Company also announced that F. Scott Reding, the Company's Chief Financial Officer, is resigning to pursue other interests.
Biodel shares up on diabetes drug marketing application
(Reuters) - Biodel Inc shares rose as much as 27 percent Thursday, a day after the company filed for marketing approval for its experimental diabetes drug VIAject.
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