DANBURY, Conn., Sept. 18 /PRNewswire-FirstCall/-- Biodel Inc. today announced additional clinical data from its VIAject(TM) program at the 43rd Scientific Sessions of the European Association for the Study of Diabetes (EASD).
VIAject(TM) Phase II meal study data was disclosed in an oral presentation at EASD entitled, “Pharmacokinetics and pharmacodynamics of insulin VIAject(TM), insulin lispro and regular human insulin when injected subcutaneously immediately before a meal in patients with Type 1 diabetes.” The VIAject (TM) Phase II meal study results demonstrated statistically significant and clinically relevant improved glycemic control compared to regular human insulin (Humulin(R) R) and lispro (Humalog(R)).
“We are pleased that VIAject(TM) continues to yield improved pharmacokinetic and pharmacodynamic data when compared to both Humulin(R) R and Humalog(R),” commented Dr. Solomon Steiner, Chairman and CEO of Biodel. “These differences translate into better glycemic control and fewer hypoglycemic events which we continue to track in our ongoing Phase III VIAject(TM) clinical trials.”
“The absorption of VIAject(TM), especially after the first 30 minutes, is much more rapid when compared to regular insulin and lispro,” elaborated Dr. Lutz Heinemann, CEO of Profil Institute for Metabolic Research in Neuss, Germany. “Improvements in pharmacokinetic and pharmacodynamic parameters may translate into improved postprandial metabolic control, resulting in a safer treatment option for the diabetic population.”
In the Phase II meal study of VIAject(TM), subjects received either VIAject(TM), Humulin(R) R (regular recombinant human insulin) or Humalog(R) (rapid acting insulin analog) in conjunction with a standardized meal. Plasma insulin and blood glucose levels were monitored throughout the study. Administration of VIAject(TM) resulted in statistically significantly faster insulin absorption than Humulin(R) R and Humalog(R) and lower plasma insulin levels than both after three hours. The data showed that VIAject(TM) provides better postprandial blood glucose control with less hyperglycemia in the first three hours after the meal and less risk of hypoglycemia in the next five hours as compared to Humulin(R) R and Humalog(R). Further data is available in the investor relations section of Biodel’s website under “Calendar of Events” at http://www.biodel.com.
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 a rapid-acting injectable meal-time insulin for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) is currently being tested in two pivotal Phase III clinical trials. Biodel’s pipeline also includes VIAtab(TM), a sublingual tablet formulation of insulin in Phase I clinical trials and two osteoporosis
product candidates in pre-clinical studies. For further information regarding Biodel, please visit the Company’s website.
Safe Harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other then statements of historical facts, including statements regarding our strategy, future operations, 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, Drugs 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 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 June 30, 2007. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
Biodel Inc.
CONTACT: Media, Carney Noensie, cnoensie@burnsmc.com, or Investors, ClayA. Kramer, ckramer@burnsmc.com, both of Burns McClellan, Inc.,+1-212-213-0006, for Biodel Inc.
Web site: http://www.biodel.com//
