DOV Pharmaceutical Announces Phase III Trial Initiation For Its Novel, Non-Narcotic Analgesic


HACKENSACK, N.J., Dec. 20 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. (NasdaqOVP) today announced initiation of a Phase III clinical trial investigating bicifadine, the Company's novel, non-narcotic analgesic, in the treatment of moderate to severe post-surgical dental pain.

This confirmatory Phase III study is a double blind, placebo-controlled, pivotal trial that compares bicifadine and tramadol to placebo using as a primary endpoint measure the Summed Pain Relief and Intensity Difference (SPRID) score, a measurement tool that reflects the total analgesia produced over the entire test period.

"In August 2002, we announced positive phase II results for bicifadine, showing it to be an effective analgesic as compared to placebo, with an efficacy at least equivalent to codeine in reducing moderate to severe dental pain. We are very encouraged by the clinical study results to date for bicifadine and look forward to the findings from this phase III study," said Dr. Bernard Beer, President of DOV.

Bicifadine is a chemically distinct molecule with a unique profile of pharmacological activity. It has two primary biochemical actions. It enhances and prolongs the actions of norepinephrine and serotonin, neurotransmitters associated with analgesia, by inhibiting the transport proteins that terminate their physiological actions. In addition, bicifadine interferes with the ability of glutamate to stimulate calcium entry into neurons. This type of calcium blockage has also been associated with analgesia. Preclinical and clinical studies indicate that either of these actions, or a combination, may account for the analgesic properties of bicifadine.

Bicifadine has been shown not to act at any opiate receptor and therefore is not a narcotic. In animal models, bicifadine did not demonstrate abuse, addiction, or dependence potential. Bicifadine development prior to this study included seven Phase I clinical trials, and 15 Phase II clinical trials, involving over 1700 patients. DOV conducts a joint venture partnership with Elan Corporation plc (NYSE:ELN) to develop controlled release formulations of bicifadine for the treatment of pain.

DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system, cardiovascular and urological disorders. The Company has five product candidates in clinical trials addressing therapeutic indications with significant unmet needs. In addition to bicifadine for pain, those candidates address insomnia (indiplon, under license to Neurocrine and in Phase III development), anxiety (ocinaplon, joint ventured with Elan), angina and hypertension (joint development with Biovail) and depression (DOV 216-303, being developed in-house).

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, as amended, and Section 21E of the Securities Exchange Act. These forward-looking statements include statements of our expectations and intentions with respect to the progress of our clinical trial programs for bicifadine. 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 certain. 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;

-- 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 obligations and required milestones under our license and other

agreements;

-- obtain substantial additional funds;

-- obtain and maintain all necessary patents or licenses; and

-- produce drug candidates in commercial quantities at reasonable costs

and compete successfully against other products and companies.

Factors that may cause our actual results to differ materially from our forward-looking statements include (i) one or more of our product candidates could be shown to cause harmful side effects, (ii) one or more of our product candidates may not exhibit the expected therapeutic results, (iii) we or the FDA may suspend one or more of our clinical trials, (iv) patient recruitment may be slower than expected or patients may drop out of our clinical trials, (v) we may not receive regulatory approval for our product candidates or approval may be delayed, (vi) our success depends on the performance of our licensees and collaborative partners, who among other things may not fulfill their obligations to us and, (vii) recent securities class action litigation may cause us to become subject to liability or become a distraction to our management. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission, including those contained in our final prospectus dated April 24, 2002. We qualify all our forward-looking statements by these cautionary statements. There may be other factors that may materially affect our forward-looking statements and our future results. Readers should not, therefore, place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.