SOURCE: Biodel, Inc.

Biodel, Inc.

September 14, 2015 18:55 ET

Biodel Announces Data Presentation at the 51st Annual Meeting of the EASD

DANBURY, CT--(Marketwired - September 14, 2015) - Biodel Inc. (NASDAQ: BIOD) announces an abstract describing a clinical standardized meal challenge study performed with BIOD-531, an ultra-rapid acting/basal insulin formulation, was selected for oral presentation at the 51st Annual Meeting of the European Association for the Study of Diabetes (EASD) being held in Stockholm, Sweden from September 14 - 18, 2015.

Dr. Linda Morrow, M.D. (Profil Institute for Clinical Research, Chula Vista, CA) will present BIOD-531 demonstrates superior prandial glucose control, post-meal dosing flexibility, and less insulin "stacking" compared to marketed prandial/basal insulins on Tuesday, September 15, 2015, in the Oral Session entitled OP 01 Insulin analogues: Is newer always better? scheduled for 10:45 AM - 12:15 PM CET (4:45 - 6:15 AM EDT).

Dr. Alan Krasner, Biodel's Chief Medical Officer, stated: "The results of this study performed in patients with type 1 or type 2 diabetes and severe insulin resistance are consistent with those seen in a previous standard meal challenge study performed in patients with type 2 diabetes and more moderate degrees of insulin resistance. In these studies, the unique biphasic profile of BIOD-531 has been shown to translate into improved postprandial control compared to marketed prandial/basal insulins in a wide spectrum of patients who use moderate to high doses of insulin."

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, 2014. 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:
    Clayton Robertson
    +1 (646) 378 2964