SOURCE: Biodel, Inc.

Biodel, Inc.

May 28, 2015 16:00 ET

Biodel to Present Data on Concentrated Ultra-Rapid-Acting/Basal Insulin and Glucagon at the 75th American Diabetes Association Scientific Sessions

DANBURY, CT--(Marketwired - May 28, 2015) - Biodel Inc. (NASDAQ: BIOD)

  • Four abstracts describing BIOD-531, the proprietary ultra-rapid-acting/basal insulin formulation, accepted for poster presentation (including one late-breaker) or publication.
  • Results from pilot study of Biodel's lyophilized glucagon formulation intended for use in auto-reconstitution device accepted as late-breaker poster presentation.

Biodel Inc. (NASDAQ: BIOD) will present data from human and animal studies with its ultra-rapid-acting/basal insulin and glucagon product candidates during the 75th Scientific Sessions of the American Diabetes Association being held at the Boston Convention and Exhibition Center in Boston, Massachusetts from June 5 - 9, 2015.

Dr. Alan Krasner, Biodel's Chief Medical Officer, stated: "We are pleased to report the results from two clinical studies demonstrating the superior prandial glucose control that can be achieved with subcutaneous injection of BIOD-531 vs. marketed prandial/basal insulins in two distinct population of patients with type 2 diabetes. The pharmacokinetic and pharmacodynamic profiles of BIOD-531 when delivered by insulin pump bolus appear to be distinct from the profiles when given by injection in the diabetic swine model. These data and the results of a pilot clinical trial showing similarity of Biodel's lyophilized glucagon formulation to marketed glucagon formulations will be presented."

Biodel presentations and published abstracts include:

Poster Presentation/Audio Tour: Postmeal Glycemia following U-400 Ultra-Rapid-Acting/Basal Insulin BIOD-531 vs. Premixed and U-500 Insulins in Patients with Type 2 Diabetes (#977-P) will be presented on Saturday, June 6, 2015, in the Poster Session entitled Clinical Therapeutics/New Technology -- Insulins scheduled for 11:30 am - 1:30 pm ET. The poster will also be showcased in the Guided Audio Tour entitled Working to Improve Mealtime Insulin Therapy on Sunday, June 7, 2015 from 1:00 - 2:00 pm ET.

Poster Presentation: Ultra-Rapid-Acting Concentrated Insulin BIOD-531 Suitability for Continuous Subcutaneous Insulin Infusion (CSII) Therapy (1016-P) will be presented on Saturday, June 6, 2015, in the Poster Session entitled Clinical Therapeutics/New Technology -- Insulins scheduled for 11:30 am - 1:30 pm ET.

Late Breaking Poster Presentation: Ultra-Rapid-Acting/Basal Concentrated Insulin BIOD-531 Demonstrates Superior Postprandial Glucose Control and Potential for Flexible Post-meal Dosing Compared with Marketed Prandial/Basal Insulins in Insulin-Resistant Patients with Type 2 Diabetes (92-LB) will be presented on Sunday, June 7, 2015, in the Poster Session entitled Clinical Therapeutics/New Technology -- Insulins scheduled for 12:00 - 2:00 pm ET.

Late Breaking Poster Presentation: Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of BIOD-961 Compared with Marketed Glucagons (2-LB) will be presented on Sunday, June 7, 2015, in the Poster Session entitled Complications-Hypoglycemia scheduled for 12:00 - 2:00 pm ET.

Published Abstract: Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling Predict Similar Dosing Frequencies for U-400 Ultra Rapid-Acting Insulin BIOD-531 Vs. Marketed Prandial-Basal Insulins will be published as #2531-PO in category 01-B Clinical Therapeutics/New Technology -- Insulins.

The presentation abstracts can be accessed by registered meeting attendees through the association's website at 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. 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