Biodel Reports Research Progress in Poster Session on Short-Acting Insulins at 46th EASD Annual Meeting
DANBURY, Conn., Sept. 23 /PRNewswire/ — Biodel Inc. (Nasdaq: BIOD) today reported recent findings from the company’s diabetes drug research program during a poster session on short-acting insulins at the 46th annual meeting of the European Association for the Study of Diabetes in Stockholm.
In the first poster presentation, “Biocompatibility of the ultra-rapid insulin VIAjectÃ‚® (Linjeta(TM)) with continuous insulin infusion sets,” Dr. Frank Flacke of Biodel reported that Linjeta(TM) was pharmacologically stable under conditions simulating continuous subcutaneous insulin infusion. Linjeta(TM) is Biodel’s more-rapid-acting insulin formulation currently under review by the U.S. Food and Drug Administration. The study found that after a four-day infusion simulation, the composition, degradation products and molecular weight of Linjeta(TM) were comparable to a reference sample stored under similar conditions. The investigators concluded that Linjeta(TM) was compatible with several commercially available insulin pump infusion sets and a viable candidate for pump delivery.
In the second poster presentation, “Pharmacokinetics of novel formulations of insulin analogs providing a more rapid onset of action in the diabetic swine model,” Dr. Roderike Pohl and colleagues from Biodel reported that reformulations of three insulin analogs – insulin lispro, insulin aspart and insulin glulisine – with excipients used in Linjeta(TM) increased their rates of absorption and elimination in eight miniature diabetic swine. The authors concluded that these rapid-acting insulin analogs may be reformulated to enable their faster absorption, more precise mealtime administration and better use in controlling post-prandial blood glucose.
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(TM) technology, which reformulates existing FDA-approved peptide drugs. Biodel’s new drug application for its most advanced product candidate, Linjeta(TM), 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(TM), 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.
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.
CONTACT: Seth Lewis, +1-646-378-2952
SOURCE Biodel Inc.