DANBURY, Conn., June 5, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) will present data from animal and human studies with its ultra-rapid-acting prandial insulin product candidates during the 72nd Scientific Sessions of the American Diabetes Association being held in Philadelphia, PA from June 8 to June 12. The data to be presented demonstrates significant progress in the development of recombinant human insulin based formulations with ultra-rapid-acting profiles. The presentations are:
- Poster: “Pharmacokinetic and Pharmacodynamic Comparison of New Ultra-Rapid-Acting Insulin Formulations in Diabetic Miniature Swine” will be presented by Roderike Pohl, Ph.D. (Biodel Inc.) on June 10 from 12:00 p.m. to 2:00 p.m. EDT #920-P, Poster Category 01-B/C Clinical Therapeutics/New Technology - Insulin Delivery Systems
- Oral: “Evaluations of Modified Ultra-Rapid-Acting Linjeta Formulations BIOD-105 and BIOD-107 in Patients with Type 1 Diabetes” will be presented by Jessica Castle, M.D. (Oregon Health and Science University) on June 11 at 5:30 p.m. EDT. #350-OR, Oral Session on Insulin Analogs
Biodel’s chief medical officer Dr. Alan Krasner stated: “Dr. Pohl will present the evaluation of BIOD-123 and BIOD-125 in the diabetic swine model, which showed an absorption profile superior to that of insulin lispro. Dr. Castle will present clinical data on BIOD-105 and BIOD-107 and will also show recently obtained clinical data for BIOD-123 and BIOD-125, which confirm the ultra-rapid absorption profile observed in the swine. Further, measurement of local injection site discomfort for BIOD-123 and BIOD-125 in the clinical trial indicated that pain scores were comparable to those associated with insulin lispro. We look forward to sharing these data with the scientific community as we prepare to initiate Phase 2 clinical trials for BIOD-123 in patients with type 1 diabetes in 3Q12.”
The abstracts can also be accessed by registered meeting attendees through the association’s web site, www.diabetes.org.
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, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the “rapid-acting” mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes; our ability advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the quarter ended March 31, 2012. 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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Contact: Seth D. Lewis, +1-646-378-2952
SOURCE Biodel Inc.
