SOURCE: Biodel, Inc.

Biodel Inc.

September 15, 2014 07:00 ET

Biodel Announces Data Presentations at the 50th Annual Meeting of the EASD

DANBURY, CT--(Marketwired - September 15, 2014) -

  • Proprietary ultra-rapid-acting insulin formulation, BIOD-531, selected by EASD for an oral presentation
  • PK/PD profiles of BIOD-531 demonstrate more rapid absorption and similar basal coverage compared to marketed prandial/basal insulin products

Biodel Inc. (NASDAQ: BIOD) will present data from human and animal studies with its ultra-rapid-acting prandial insulin product candidates during the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) being held in Vienna, Austria from September 15-19, 2014. The data to be presented demonstrate significant progress in the development of recombinant human insulin-based formulations. The presentations are as follows:

Oral Presentation: A novel concentrated recombinant human insulin formulation with improved ultra-rapid action for continuous subcutaneous infusion therapy will be presented by Roderike Pohl, Ph.D. (Biodel Inc.) on Thursday, September 18, 2014, in the Oral Session entitled OP 25 Novel insulin formulations and combinations scheduled for 10:15-11:45 am CET (4:15-5:45 am EST). Abstract is available at http://www.easdvirtualmeeting.org/resources/15107.

Poster Presentation: Biphasic pharmacokinetic and pharmacodynamic profiles associated with concentrated insulin BIOD-531show rapid onset and basal duration of action will be presented by Linda Morrow, M.D. (Profil Institute for Clinical Research, Inc.) on Tuesday, September 16, 2014, at 2:15 pm CET (8:15 am EST) as Poster #937. http://www.easdvirtualmeeting.org/resources/16003.

Dr. Alan Krasner, Biodel's Chief Medical Officer, stated: "The pre-clinical and clinical data to be presented at EASD this year demonstrate the unique and attractive pharmacokinetic and pharmacodynamic profiles of BIOD-531. This formulation of recombinant human insulin has the potential to provide improved glucose control compared to marketed insulin products designed to provide both prandial and basal coverage in a single injection. Because BIOD-531 is a concentrated formulation (400 units/ml or U-400), this degree of control can be achieved with small volume injections."

The presentation abstracts can be accessed by members through the association's website, www.EASD.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. Biodel's product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available 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 and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; 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 December 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.

BIOD-G

Contact Information

  • CONTACT:
    John Graziano
    +1 (646) 378 2942