SOURCE: Biodel Inc.

Biodel Inc.

October 19, 2015 16:30 ET

Biodel Announces Data Presentations at the Diabetes Technology Society Conference

DANBURY, CT--(Marketwired - October 19, 2015) - Biodel Inc. (NASDAQ: BIOD) will present data from studies of its ultra-rapid-acting prandial/basal insulin and Glucagon Emergency Management (GEM) product candidates during the Diabetes Technology Society Conference to be held in Bethesda, MD from October 22 - 24, 2015.

The poster presentation (4:00 pm - 6:30 pm ET on Thursday, October 22, 2015) "Mixture of Insulin Monomers, Dimers and Hexamers Demonstrated by Sedimentation Velocity Analysis Supports Bi-Phasic Ultra-Rapid-Acting and Basal Profile of Concentrated Human Insulin Formulation BIOD-531" will detail the molecular mechanism for the unique, bi-phasic profile of BIOD-531, the Company's proprietary, potentially best-in-class, ultra-rapid acting prandial/basal insulin candidate.

The poster presentation (4:00 pm - 6:30 pm ET on Thursday, October 22, 2015) "Biodel's Glucagon Emergency Management (GEM) Auto-Reconstitution Device Demonstrates Superior Usability Compared to Marketed Glucagon Kits in Human Factors Study" will present data from formative Human Factors Studies which demonstrate clear-cut superiority of the GEM device with regard to ease-of-use, overall performance and reduction in dosing errors in comparison with the currently marketed glucagon kits.

The poster presentation (4:45 pm - 7:15 pm ET on Friday, October 23, 2015) "Pharmacokinetic and Pharmacodynamic Modeling Predict Concentrated Biphasic Insulin BIOD-531 Is Suitable for Twice or Three Times Daily Dosing with No Dose Accumulation" will present mathematical modeling of the pharmacokinetic and pharmacodynamic profiles of BIOD-531. These models predict that BIOD-531 is well suited for user-friendly dosing paradigms that are already commonly used in clinical practice.

The presentation abstracts can be accessed by members through the association's website, www.diabetestechnology.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 Biodel's product candidates, potential timing, design and outcomes of clinical trials and Biodel's ability to develop and commercialize its product candidates. Forward-looking statements represent Biodel's management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel's 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. Biodel'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 progress, timing or success of Biodel's research and development and clinical programs for Biodel's product candidates; Biodel's ability to conduct the development work necessary to finalize the formulation and design of Biodel's auto-reconstitution glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate; Biodel's ability to engage a strategic partner in the further development of Biodel's prandial ultra-rapid-acting insulin formulations, including BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient, and Biodel's insulin analog-based formulations; the success of Biodel's formulation development work to improve the stability of Biodel's newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations; the results of Biodel's real-time stability programs for Biodel's RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and Biodel's ability to accurately project long term stability on the basis of accelerated testing; Biodel's ability to accurately anticipate technical challenges that the company may face in the development of Biodel's ultra-rapid-acting RHI- and insulin analog-based product candidates or Biodel's glucagon rescue product candidates; Biodel's ability to secure approval by the FDA for Biodel's product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; Biodel's ability to enter into collaboration arrangements for the commercialization of Biodel's product candidates and the success or failure of any such collaborations into which the company enters, or Biodel's ability to commercialize its product candidates on its own; Biodel's ability to enforce Biodel's patents for Biodel's product candidates and Biodel's ability to secure additional patents for Biodel's product candidates; and other factors identified in our most recent annual report on Form 10-K for the fiscal year ended September 30, 2014 and other subsequent filings with the Securities and Exchange Commission. 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, Trout Group
    +1 (646) 378 2964