- Selected by ADA for late breaking presentation of Biodel's proprietary ultra-rapid-acting analog formulations
- Presentation of data for new class of concentrated ultra-rapid-acting insulin designed to address insulin resistant patients and patients who use prandial and basal insulin premixes
DANBURY, Conn., June 17, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) will present data from human and animal studies with its ultra-rapid-acting prandial insulin product candidates during the 73rd Scientific Sessions of the American Diabetes Association being held at the McCormick Place Convention Center in Chicago, Illinois from June 21 to June 25. The data to be presented demonstrate significant progress in the development of both recombinant human insulin-based and insulin analog-based formulations with ultra-rapid-acting profiles. The presentations are:
Late Breaking Poster Presentation: "Formulations BIOD-238 and BIOD-250 Associated With Faster Absorption and Declines From Peak Concentrations Compared to Humalog®" will be presented by Alan Krasner, M.D. (Biodel Inc.) on Sunday Jun 23, 2013, 12:00 p.m. - 2:00 p.m. CDT, #44-LB in category 01-C Clinical Therapeutics/New Technology – Insulins.
Poster Presentation: "BIOD-530/531 U-400 Concentrated Recombinant Human Insulin: Pharmacokinetic and Pharmacodynamic Profiles in Diabetic Swine Compared to U-500 regular human insulin and U-100 Insulin Lispro" will be presented by Roderike Pohl, Ph.D. (Biodel Inc.) on Saturday, June 22, 2013, 11:30 a.m. - 1:30 p.m. CDT, # 918-P in category 01-C Clinical Therapeutics/New Technology – Insulins.
Biodel's chief medical officer Dr. Alan Krasner stated: "We will present clinical data on BIOD-238 and BIOD-250, which demonstrate significantly more "rapid in" and "rapid out" pharmacokinetic profiles relative to Humalog® and could address an unmet medical need for prandial insulins with profiles more closely resembling normal physiology. Dr. Pohl will present the evaluation of concentrated insulin candidate BIOD-531 in the diabetic swine model, which showed an early absorption profile similar to or superior to that of Humalog® and superior to Humulin® R U-500. BIOD-531has been selected for Phase 1 clinical study as it could address an unmet medical need for the growing population of severely insulin resistant type 2 diabetes patients who require greater than 200 units of insulin daily and for whom no rapid-acting or ultra-rapid-acting concentrated insulins currently exist."
The presentation abstracts can 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 more information, please visit 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 and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; our ability to successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; 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 or a stable glucagon presentation; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a stable glucagon presentation; 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, 2013. 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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