DANBURY, Conn., Sept. 27 /PRNewswire-FirstCall/ -- Biodel Inc. today announced the receipt of a notice of issuance from the United States Patent and Trademark Office (USPTO) for the Company’s patent encompassing VIAject(TM) and VIAtab(TM), Biodel’s two product candidates in clinical trials. The notice of issuance provides that U.S. Patent No. 7,279,457 will issue on October 9, 2007. The patent will expire in January 2026.
“This patent validates Biodel’s proprietary rights in our VIAdel(TM) technology and will protect our company’s current clinical stage product candidates, VIAject(TM) and VIAtab(TM),” stated Dr. Solomon S. Steiner, Chairman and CEO of Biodel. “In addition, this patent represents a significant milestone in our strategy to build our intellectual property portfolio.”
About VIAject(TM) and VIAtab(TM)
VIAject(TM) is a 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) is currently being tested in two pivotal Phase III clinical trials, which are comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.
VIAtab(TM) is a sublingual tablet formulation of insulin, currently in Phase I clinical trials. VIAtab(TM) demonstrated encouraging safety and pharmacokinetic profiles in Phase I clinical testing.
About VIAdel(TM) Technology
VIAdel(TM) technology allows for a more effective delivery of endocrine therapeutics as well as increased efficacy and safety. This patented technology is applicable to a wide range of peptides, proteins and other macromolecules. Biodel’s lead product candidates, VIAject(TM) and VIAtab(TM) for diabetes, utilize VIAdel(TM) technology. Additionally, Biodel is developing other therapies, such as VIAmass(TM) and VIAcal(TM), to treat osteoporosis. All of Biodel’s proprietary technologies and products have been developed in-house.
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 in development 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 at http://www.biodel.com.
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, 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 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.
BIOD-G
Biodel Inc.
CONTACT: Investors, Clay A. Kramer, ckramer@burnsmc.com; Media, CarneyNoensie, cnoensie@burnsmc.com, both of Burns McClellan, Inc.,+1-212-213-0006, for Biodel Inc.
Web site: http://www.biodel.com/
