EXHIBIT 99.1
For Immediate Release
Contact:
(Company) (Corporate Communications)
Barbara Duncan Kathleen Eppolito
Chief Financial Officer Scientia Communications, Inc.
DOV Pharmaceutical, Inc. (718) 281-1809
(201) 968-0980
DOV INITIATES PHASE III LONG TERM SAFETY CLINICAL TRIAL FOR
BICIFADINE, ITS NOVEL ANALGESIC
Hackensack, NJ, December 15, 2004. DOV Pharmaceutical, Inc. (Nasdaq: DOVP)
announced today that it has initiated a pivotal, Phase III, U.S. multi-center
clinical trial to evaluate the long-term safety of bicifadine in patients with
chronic lower back pain. DOV is currently conducting three of the seven planned
Phase III clinical trials with bicifadine according to the clinical program
accepted by the Food and Drug Administration, or FDA, at DOV's end of Phase II
meeting for the treatment of acute pain and chronic lower back pain.
This clinical trial will enroll approximately 1,550 patients with chronic lower
back pain, 1,050 of whom will be entered directly into this study and randomized
to receive either 400 mg of bicifadine b.i.d. or any appropriate pharmacological
analgesic treatment selected by the investigator. In addition, the clinical
trial will enroll approximately 500 patients who will have completed 12 weeks of
treatment in either the ongoing Phase III chronic lower back pain clinical trial
or the confirmatory Phase III chronic lower back pain clinical trial currently
planned for the second half of 2005. Such patients will receive 400 mg of
bicifadine b.i.d. The primary objective of this clinical trial is to evaluate
the safety of bicifadine for up to one year in patients with chronic lower back
pain. This trial is expected to be conducted in approximately 150 centers in the
U.S.
In March 2004, DOV and the FDA reached agreement on a plan for the balance of
the Phase III bicifadine program necessary to submit an NDA for both acute pain
and chronic lower back pain. As part of the NDA package for one or the other
indication, the plan requires DOV to conduct a long-term safety clinical trial.
The Phase III trial announced today is designed to meet this portion of the
overall NDA plan.
Dr. Warren Stern, DOV's senior vice president of drug development, stated, "This
study of up to 12 months of dosing with bicifadine is significant in that it is
intended to provide evidence regarding the safety of bicifadine required by the
FDA as part of the clinical information required in an NDA. From the patient's
perspective, this study provides the opportunity to receive long term therapy
for his or her chronic lower back pain with a new medication. From a commercial
perspective, this trial will provide information related to the pharmacoeconomic
impact of bicifadine, information that plays a key role in the acceptance of new
treatments by the formulary committees of health management organizations."
About Bicifadine
Bicifadine is a chemically distinct molecule with a unique profile of
pharmacological activity. It is not a narcotic and, in preclinical studies, has
been shown not to act at any opiate receptor. In animal models, bicifadine does
not demonstrate abuse, addiction or dependence potential.
Drugs for the treatment of pain, or analgesics, have historically been placed
into one of two general categories:
o narcotics, e.g., morphine, codeine, Demerol and Percodan; and
o non-narcotic prostaglandin inhibitors, e.g., aspirin, acetaminophen,
ibuprofen and COX-2 inhibitors.
While drugs in both of these categories are regularly used in the treatment of
pain, their use has been limited because of various side effect profiles. In
addition, administering these drugs for extended durations has been problematic.
Although prostaglandin inhibitors have been used for the treatment of pain,
particularly pain associated with inflammation, their efficacy is often limited
to milder types of pain and they may display undesirable side effects relating
to the gastrointestinal tract and liver. Narcotics are also used to treat pain,
but tolerance develops rapidly and higher doses eventually lead to physical
dependence and additional side effects, including constipation and respiratory
depression. Therefore, we believe patients with moderate to severe pain will
benefit from the use of bicifadine. Based on clinical data to date patients are
expected to experience pain relief comparable to that associated with a narcotic
without the side effects normally associated with this class of drugs. According
to IMS, a market research organization, U. S. sales in 2002 of narcotic and
non-narcotic analgesics exceeded $5.7 billion.
About DOV
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. We have seven product candidates undergoing clinical
development that address therapeutic indications with significant unmet needs.
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 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 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) we may
not receive regulatory approval for our product candidates or approval may be
delayed and (vi) our success depends on the performance of our licensees and
collaborative partners who among other things 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, 2004. 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.