SOMERSET, N.J., July 26 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced today the completed assessment of results from the carcinogenicity studies for its novel analgesic, bicifadine. There were no meaningful signals of carcinogenicity detected after two years of testing in two species -- rats and mice. The Company believes these results are very positive, as this outcome from these two important safety studies will support the ability of DOV to file an NDA with the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide.
“While this package must also be reviewed by experts at U.S. and international regulatory agencies, both our internal experts and external team of consultants are pleased with the outcome of these studies,” said Dr. Joseph Tizzano, Senior Director of Toxicology at DOV. “The safety of bicifadine in these long-term carcinogenicity studies compares favorably to many drugs currently marketed to treat chronic pain conditions, including neuropathic pain.”
Carcinogenicity studies are required by the FDA and are a critical part of the NDA packages submitted to the Agency. Carcinogenicity studies are performed by administering maximum doses of a drug in two species (usually rats and mice) for a period of two years. This timeframe is accepted as analogous to administering the drug over a lifetime in humans.
“These carcinogenicity data underscore and reinforce the findings from our long-term safety database for bicifadine in humans,” said Dr. Warren Stern, Senior Vice President of Drug Development at DOV. “The data collected to-date indicate that bicifadine is very safe and well-tolerated, properties that in combination with its previously reported efficacy should enhance our ability to build a strategic partnership to develop and commercialize the drug.”
About DOV
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system disorders. The Company’s product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain and depression.
Cautionary Note
Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:
* demonstrate the safety and efficacy of product candidates at each stage of development; * develop and execute Phase II and III clinical programs for bicifadine, our novel analgesic, revised as necessary to take into account the drug’s recent failure to achieve statistically significant effect relative to placebo; * meet our development schedule for our product candidates, including with respect to clinical trial initiation, enrollment and completion; * meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all; * meet or require our partners to meet obligations and achieve milestones under our license and other agreements; * successfully execute the development plan under and otherwise achieve the results contemplated by the 2005 amendment to our license agreement with Merck; * obtain and maintain collaborations as required with pharmaceutical partners; * obtain substantial additional funds; * obtain and maintain all necessary patents, licenses and other intellectual property rights; and * produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.
You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2006 and our quarterly report on Form 10-Q filed on May 9, 2006. We qualify all our forward-looking statements by these cautionary statements. Readers should not place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
DOV Pharmaceutical, Inc.
CONTACT: Keri P. Mattox, Director, Investor Relations and CorporateCommunications, DOV Pharmaceutical, Inc., +1-732-907-3600
Web site: http://www.dovpharm.com/
