Biodel Announces Publications Demonstrating Superior Metabolic Profile of VIAject Compared to the Rapid-acting Analog Humalog and Regular Human Insulin in Healthy Volunteers and Compared to Regular Human Insulin in Patients with Type 1 Diabetes
In the Phase I glucose clamp study (Steiner et al., Diabetologia, 2008), ten healthy volunteers received subcutaneous injections of VIAject(TM) ultra rapid-acting insulin, insulin lispro (Humalog(R)) or regular human insulin on separate days. The study showed that VIAject(TM) was absorbed and produced its metabolic effect faster than both regular human insulin and insulin lispro (Humalog(R)) at the same dose.
In a Phase II glucose clamp study (Hompesch et al., J. of Diabetes Science and Technology, July 2008), fourteen patients with type 1 diabetes were randomly assigned to receive two sequences of three subcutaneous injections of 0.1 IU/kg of VIAject(TM) or regular human insulin on separate days. Patients receiving VIAject(TM) had an earlier onset of action and shorter time to maximal plasma insulin concentration when compared to regular human insulin, confirming previous findings in healthy volunteers that VIAject(TM) is absorbed more quickly and has a more rapid onset of action and clearance than regular human insulin.
"We welcome the publication of these earlier findings. These data led to the pivotal Phase III clinical trials assessing efficacy and safety in patients with Type1 and Type 2 diabetes," stated Dr. Solomon Steiner, chief executive officer and chairman of Biodel. "The last patients recently completed these pivotal Phase III trials and we look forward to analyzing and reporting these data."
VIAject(TM) is an ultra rapid-acting injectable human insulin intended for meal-time use by patients with Type 1 or Type 2 diabetes. In Phase I and Phase II clinical trials, VIAject(TM) has been shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs. As a result, VIAject(TM) may be safer, require a lower dose and promote weight loss when compared to currently marketed meal-time insulins. VIAject(TM) has been tested in two pivotal Phase III clinical trials, which compared the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The company's lead product candidate, VIAject(TM), is an ultra rapid-acting injectable meal-time insulin in development for use by patients with type 1 or type 2 diabetes. VIAject(TM) has been tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM) a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. 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. 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 our 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; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure additional patents for VIAject(TM) and our other product candidates; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2008. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
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Seth Lewis, 617-583-1308
Posted: July 2008