DANBURY, CT -- (Marketwired) -- 10/12/15 -- Biodel Inc. (NASDAQ: BIOD) today announced that the United States Food and Drug Administration (FDA) has removed the partial clinical hold for Biodel's previously initiated Phase 2b Study 3-250, a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes comparing the use of BIOD-531 to Humalog® Mix 75/25. The correspondence from the FDA clears the use ofBiodel's investigational U-400 syringes in the clinical trial. Additionally, in the fourth calendar quarter of 2015, the Company will begin a Phase 2a standardized meal challenge study and independent market analysis to determine whether the target diabetes populations and market segments for BIOD-531 can be further expanded.
The Phase 2a standardized meal challenge study will evaluate the hypothesis that treatment with BIOD-531 can reduce the injection burden and achieve glucose control at least as effective as that with separate basal and prandial insulins in patients with type 2 diabetes. The market analysis will assess the optimal target patient populations and commercial opportunity for BIOD-531, including patients who are on intensive basal/prandial insulin therapy. In anticipation of this potential expanded market opportunity, the Company has decided to continue Study 3-250 to allow completion of patients currently in the trial while deferring recruitment of new patients until the optimal target population(s) have been selected following review of top-line data from the new Phase 2a meal study and the results of the market analysis in the first calendar quarter of 2016.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are pleased that the FDA has cleared our investigational U-400 syringes for use in an outpatient Phase 2b study and look forward to new data which will further inform later stage multi-dose clinical trials with the optimal patient population and comparators early next year."
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.
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'smanagement's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel'sstrategy, 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'sproduct 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.
Clayton Robertson, The Trout Group
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