Healthcare Industry News: osteoporosis
News Release - March 24, 2009
Biodel to Submit New Drug Application for VIAject to FDAConference Call Tomorrow March 25 at 8:00 AM (ET)
DANBURY, Conn.--(HSMN NewsFeed)--Biodel Inc. (Nasdaq: BIOD ) announced today 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.
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 (EASD). 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® 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.”
Conference Call and Webcast Information
Biodel's senior management team will host a conference call on Wednesday, March 25, 2009 at 8:00 AM Eastern Time. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 877-741-4248 (United States) or 719-325-4752 (international). To access the call by live Webcast, please log on to the Investor section of Biodel's Web site at www.biodel.com. An archived version of the Webcast will be available at Biodel's Web site.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed using VIAdelTM technology, which reformulates existing FDA-approved peptide drugs. For further information regarding Biodel, please visit the company's website at www.Biodel.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to have our VIAject® NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject® and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology, particularly VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA’s findings regarding data anomalies observed in India in our Phase III clinical trial of VIAject® for patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended December 31, 2008. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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