DANBURY, Conn., Sept. 21 /PRNewswire/ -- In a platform presentation at the 46th annual meeting of the European Association for the Study of Diabetes (EASD) in Stockholm, investigators for Biodel Inc. (Nasdaq: BIOD) today presented the results of a clinical study evaluating a new pH-neutral formulation of Linjeta™ (VIAject®). Dr. Tim Heise (Profil Institute for Metabolic Research, Neuss, Germany) and colleagues reported that the new pH-neutral, 100 IU/ml formulation of Linjeta™ was bioequivalent to the previously studied pH-4, 25 IU/ml formulation of Linjeta™, and had faster absorption and onset of action than insulin lispro. These findings were also presented by Dr. Heise in June at the 70th scientific sessions of the American Diabetes Association in Orlando, Florida.
Linjeta™ is Biodel's more-ultra-rapid-acting insulin formulation that is currently under review by the U.S. Food and Drug Administration. The purpose of this study was to demonstrate the bioequivalence of the two formulations of Linjeta™, compare the pharmacokinetic and pharmacodynamic characteristics of pH-neutral, 100 IU/ml Linjeta™ and insulin lispro in 43 patients with Type 1 diabetes. The trial was conducted as a randomized, double-blind crossover study. There were no serious adverse events or discontinuations because of treatment-emergent adverse events; headache was the most frequent adverse event reported (8 patients). Additional studies are planned to evaluate the impact of Linjeta™ on glucose control.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. Biodel's product candidates are developed using VIAdel™ technology, which reformulates existing FDA-approved peptide drugs. Biodel's new drug application for Linjeta™, its most advanced product candidate, has been accepted for review by the FDA with a Prescription Drug User Fee Act action date of October 30, 2010. Earlier-stage product candidates include VIAtab™, a sublingual tablet formulation of insulin, a line of basal insulins and a stabilized formulation of glucagon. For further information regarding Biodel, please visit the company's website at www.biodel.com. Contact:The Trout Group LLCSeth D. Lewis, +1-646-378-2952Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, our ability to secure FDA approval for Linjeta(TM) and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology, particularly Linjeta(TM) the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of Linjeta(TM) for patients with Type 1 diabetes; the possibility that patients taking Linjeta(TM) may experience more injection site discomfort than they experience with competing products; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended June 30, 2010. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
|SOURCE Biodel Inc.|
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