EXHIBIT 99.1
FOR IMMEDIATE RELEASE
Contact:
DOV Pharmaceutical, Inc.
(201) 968-0980
Barbara Duncan Alan Beckhard
Chief Financial Officer Manager, Investor Relations and Corporate
Communications
DOV Pharmaceutical, Inc. Places Ocinaplon Phase III Clinical Trial On Hold
Hackensack, NJ, August 25, 2005. DOV Pharmaceutical, Inc (NASDAQ: DOVP)
announced today that it has suspended further dosing in the ongoing phase III
clinical trial of ocinaplon, its novel anti-anxiety agent. This double-blind
study had been intended to treat up to 373 healthy subjects and patients with
generalized anxiety disorder with 60 mg/day of ocinaplon or placebo for four
weeks. Approximately 200 subjects and patients have been randomized to
treatment.
The recent occurrence of enzyme elevations in liver function tests (LFTs) for
one subject in this trial were of sufficient concern that DOV, in consultation
with the independent data monitoring committee, decided to suspend the trial.
This will enable DOV to unblind the study results and fully evaluate the safety
findings from all subjects in the clinical trial. The data from the one subject
could be an outlier or could represent a consistent adverse effect of the study
drug. Several other subjects had elevations of LFTs but not to a degree
sufficient to stop dosing. DOV has notified the U.S. Food and Drug
Administration (FDA) of its actions and will provide the results of these
interim analyses to the FDA.
DOV will continue to monitor the subjects and patients currently enrolled in the
clinical trial and, upon full analysis and completion of its review, make a
decision to continue with ocinaplon or select a back-up compound. DOV will
consult with the FDA prior to any decision to resume dosing at the current level
or with a reduced dosage regimen. This process is likely to take several months.
"While committed to moving forward with the development of ocinaplon, DOV is,
first and foremost, dedicated to ensuring the safety of all participants in our
clinical trials," said Dr. Warren Stern, Senior Vice President of Drug
Development at DOV. "In addition to ocinaplon, DOV's active and ongoing GABA
modulator program for the treatment of anxiety includes several late-stage
preclinical candidates that could substitute for ocinaplon if required."
* * *
DOV will host a conference call on August 26, 2005 at 7:30 a.m. ET. The audio
Web cast can be accessed at http://www.dovpharm.com under Investor Relations and
will remain archived on the Web site for 90 days. The dial-in numbers for the
live teleconference are as follows: (Toll Free) 1-877-407-8031 and
(International): 1-201-689-8031. A full replay of the conference call will be
available through September 2, 2005. The replay can be accessed by dialing:
(Toll Free) 1-877-660-6853 and (International): 1-201-612-7415 and entering
account # 286 and conference ID# 167030.
* * *
DOV is a biopharmaceutical company focused on the discovery, acquisition,
development and commercialization of novel drug candidates for central nervous
system and other disorders, including cardiovascular, that involve alterations
in neuronal processing. Our product candidates address some of the largest
pharmaceutical markets in the world including insomnia, pain, anxiety and
depression. Our partner Neurocrine has filed two NDAs for the use of DOV's
compound indiplon for the treatment of insomnia.
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. 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:
o demonstrate the safety and efficacy of product candidates at each
stage of development;
o meet our development schedule for our product candidates, including
with respect to clinical trial initiation, enrollment and
completion;
o develop an acceptable development plan under and otherwise achieve
the results contemplated by the recent amendment to the existing
license agreement with Merck;
o meet applicable regulatory standards and receive required regulatory
approvals on our anticipated time schedule or at all;
o meet obligations and required milestones under our license and other
agreements;
o obtain and maintain collaborations as required with pharmaceutical
partners;
o obtain substantial additional funds;
o obtain and maintain all necessary patents or licenses; and
o 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)
regulatory approval for our product candidates may not be received or may be
delayed, and (vi) performance of our licensees and collaborative partners on
whom our success depends may not fulfill their obligations to us. 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, 2005. 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.