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Biodel Announces Accelerated Development Plan for Ultra-Rapid-Acting Insulins: Initiate Phase 2 in 2011; Phase 3 Pivotal Trials in 20126:59 am ET 03/14/2011 - PR NewswireDANBURY, Conn., Mar. 14, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins. Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes. This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog® each on separate occasions. This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®. In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year.
If this Phase 1 study is successful, Biodel now anticipates initiating a Phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011. The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials-- one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes. Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials. Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog® as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing. In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles. If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.
"We look forward to obtaining initial clinical data for BIOD-105 and BIOD-107," said Dr. Alan Krasner, Chief Medical Officer of Biodel. "Based on pharmacokinetic data obtained in the diabetic swine model, these formulations appear to be very rapidly absorbed, similar to rates of absorption seen with the previously studied Linjeta™ formulations. Based on last year's clinical data from related formulations BIOD-102 and BIOD-103, we anticipate improved injection site tolerability with BIOD-105 and BIOD-107. We were very pleased with our end of review meeting with the FDA in which they confirmed study details including the use of Humalog® as a comparator in future clinical trials. The FDA also confirmed that data from the development program for the new formulations would be classified as a Class 2 resubmission with a 6 month review time."
"We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra-rapid-acting human insulin drug candidates," said Dr. Errol De Souza, president and CEO of Biodel. "By achieving our candidate selection milestone and receiving constructive feedback from the FDA during our end of review meeting, we have accelerated the clinical development program of these formulations and plan to initiate Phase 1 clinical testing this month and could initiate Phase 3 testing before the end of 2012."
Biodel now expects to complete the Phase 1 study and launch Phase 2 testing in the third and fourth calendar quarters of 2011, respectively.
Dr. De Souza will address these accelerated time lines and other updates in a presentation at the Roth 23rd Annual OC Growth Stock ConferenceWednesday, March 16th at 1:00 p.m. Pacific Time (4:00 p.m. Eastern Time). Interested parties may access the presentation in the investor relations section of Biodel's website at www.biodel.com which will link to a live webcast to be archived for 14 days.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. 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. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. 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 respond to the complete response letter regarding our new drug application for Linjeta™ in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta™ 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; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the possibility that patients taking Linjeta™ may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; 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 most recent annual report on Form 10-Q for the quarter ended December 31, 2010. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
