Following completion
of this clinical trial, we intend, in 2005, to
initiate two additional Phase I clinical trials and
a Phase II clinical trial
for DOV 102,677. Before licensing DOV 21,947 to Merck, DOV obtained an
IND and
completed four Phase I pharmacokinetic clinical trials, including a Phase Ib
clinical
trial of multiple doses of DOV 21,947. We have six product candidates undergoing clinical
development
that address therapeutic indications with significant unmet needs.
However, Neurocrine has announced
that these applications were not accepted by
the FDA due to technical difficulties in navigating
the electronic filing and
that it intends to refile the applications in the first half of 2005. 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.
News + World
Report listed Bascom Palmer Eye Institute as the number one hospital
in the country
for ophthalmology.misconceptions irresistible
Dr. Inc. Phase II study
for the treatment of patients diagnosed with pathological
gambling,
one of the designated ICDs. Research
is a top priority, with more than 1,300 ongoing
projects funded by
$196 million in external grants and contracts to UM faculty.
Somaxon cautions
you that statements included in this press
release that are not a description of historical facts
may be
forward-looking statements.shoplifter questionnaires
We
qualify all our forward-looking statements by these cautionary
statements. The license from the
University of Miami extends the scope of oral nalmefene's potential
uses. Each year, 35 million smokers make a
serious attempt to quit; 93 percent fail(1).prozac shoplifters
In
the
Merck transaction, DOV received a $35 million up-front licensing payment
with the opportunity to
receive an additional $300 million for achieving
clinical development, regulatory and approval milestones
and $120 million upon
achievement of targeted sales thresholds. patent on the use oral nalmefene
hydrochloride for
the treatment of nicotine dependence invented by Dr.nig.impulse honest
As announced in November
2004, Somaxon licensed the North American
rights to develop, manufacture and commercialize oral nalmefene
from
BioTie Therapies Corp.
According to the Centers for Disease Control and Prevention,
cigarette
smoking remains the leading preventable cause of death in
the United States, accounting for approximately
1 of every 5 deaths
(440,000 people) annually.
"In clinical studies, opiate antagonists have demonstrated
an
effect in treating substance abuse addictions, notably alcoholism. We intend to explore that
potential
in our clinical development program for oral nalmefene,"
said Ken Cohen, Somaxon President and CEO
. Actual results may differ
materially from those set forth in this release due to the risks and
uncertainties
inherent in Somaxon's business including, without
limitation, statements about: the progress and
timing of its clinical
trials; difficulties or delays in development, testing, obtaining
regulatory
approval, producing and marketing its products; unexpected
adverse side effects or inadequate therapeutic
efficacy of its product
candidates that could delay or prevent product development or
commercialization
, or that could result in recalls or product
liability claims; the scope and validity of patent protection
for its
product candidates; competition from other pharmaceutical or
biotechnology companies;
and its ability to obtain additional
financing to support its operations.compulsive harmful
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. Emerging
evidence suggests there may be a common
relationship between impulse
control disorders and substance abuse. The most advanced
clinical
program focuses on the evaluation of low-dose doxepin for the
treatment of insomnia, a condition
that, according to the National
Sleep Foundation's, Sleep in America Poll affects more than 50 million
Americans. Somaxon intends to initiate the first of two pivotal
Phase III clinical trials in 2005
for the use of oral nalmefene for
the treatment of pathological gambling.dsm ssri
In addition, our partner
, Neurocrine, in the fourth quarter of 2004 filed two
NDAs, the first for an immediate release formulation
and the second for a
modified release formulation of indiplon for the treatment of insomnia. 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.
There may be other factors that may materially affect our forward-looking
statements
and our future results.
(1) National Institute on Drug Abuse.nida.dsm honest
Both preclinical studies
and clinical trials indicate that a drug
inhibiting reuptake of all three such neurotransmitters
will produce more
rapid onset of action and greater efficacy than traditional antidepressants.potentially steal
S.
No currently marketed antidepressant inhibits the reuptake of all three
neurotransmitters
linked to depression: serotonin, norepinephrine and
dopamine.D.
About the University of Miami
Serving more than six million people as the only academic medical
center in South Florida
, the University of Miami Leonard M.gov/researchreports/nicotine/nicotine2.prozac shoplifter
Merck has rights of first
offer and
refusal if the Company determines to commercialize DOV 102,677 for depression
or anxiety
., a specialty pharmaceutical company
focused on developing and marketing products for the treatment
of
neuropsychiatric disorders, today announced that it has licensed the
rights to a U. Barbara
Mason
while at the University of Miami. In 2004, U.epidemiology antisocial
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.
Business
Editors/Health/Medical Writers
BIOWIRE2K
SAN DIEGO----
Company Intends To Initiate
Proof-of-Principle Study in 2005
Somaxon Pharmaceuticals Inc.S. Nicotine is a highly
addictive
substance that causes the release of several hormones that
act on various receptors in the brain
to cause euphoria, enhance mood
and performance, and lead to dependence.
"This license to the
University of Miami patent for the use of
oral nalmefene for the treatment of nicotine dependence
allows us to
expand our patent portfolio surrounding this compound.compulsive kleptomania
DOV 102,677 is the third of
DOV's triple reuptake
inhibitors to enter the clinic. For DOV 216,303, DOV
completed two Phase
I pharmacokinetic clinical trials and a Phase II multi-
centered, double-blind, safety, efficacy
and tolerability clinical trial that
compared DOV 216,303 to citalopram, a selective serotonin reuptake
inhibitor,
or SSRI, in patients with major depressive disorder. Miller
School of Medicine has
earned international acclaim for research,
clinical care, and biomedical innovations. Seven additional
UM School of
Medicine specialties were also listed among the nation's best: kidney
disease; hormonal
disorders; ear, nose and throat; geriatrics;
digestive disorders; neurology and neurosurgery; and
urology.harmful stealing
A Phase II trial with oral nalmefene II for the treatment of
pathological gambling was
completed by Somaxon's strategic partner,
BioTie Therapies. Pathological Gambling is a
growing
health concern that has been recognized by the Diagnostic and
Statistical Manual of Mental Disorders
, American Psychiatric
Association since 1980. All forward-looking statements
are qualified in
their entirety by this cautionary statement and
Somaxon undertakes no obligation to revise or update
this news release
to reflect events or circumstances after the date hereof.
shoplifter reuptake
Readers should not
, therefore, place undue
reliance on our forward-looking statements. Somaxon intends to initiate Phase
III
trials for this indication during 2005. Founded in 1952 as
Florida's first accredited medical
school, the University of Miami
provides the medical staff for the nationally renowned University
of
Miami/Jackson Memorial Medical Center.potentially steal
(Nasdaq: DOVP), a leader in triple reuptake inhibitor drug
discovery and
development, announced today that it has initiated the first Phase I clinical
trial
with DOV 102,677, believed to be a potent inhibitor of serotonin,
norepinephrine and dopamine reuptake
, with preferential action on the dopamine
transporter protein. 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. It is estimated that
in North America there
are approximately 3 million pathological gamblers.kleptomania honest
Arnold Lippa, DOV's CEO
, will cover the above information at his
corporate presentation scheduled for 12:00 noon today at
the BIO CEO
Conference 2005 at the Waldorf-Astoria in New York City. It is theorized that pathways
involving opioid receptors may play a role in the development and
reinforcement of both substance
-related and behavior-related
addictions including nicotine dependence. The product is currently in
Phase II clinical trials.ssri compulsive
We do not undertake any
obligation and do not intend to update any forward
-looking statement.potentially shoplifters
This clinical trial is a double-blind,
randomized, placebo controlled study to
evaluate the safety, pharmacokinetics
and pharmacodynamics of a range of escalating single doses
of DOV 102,677 in
healthy volunteers. investigational
new drug application (IND)."
DOV
's discovery efforts have yielded a growing library of novel triple
reuptake inhibitors and the Company
intends to bring at least one of these
compounds into clinical development annually. Oral nalmefene
has completed a U. Somaxon intends to initiate a proof-of-principle study this year
for the use of
oral nalmefene to decrease nicotine dependence. The Company
has several product candidates in development
.kleptomania shoplifter
HACKENSACK, N.
Dr.
www.Sites dealing with the mental health issue of impulsive and irresistible
acts of stealing and shoplifting, despite awareness of potentially self-harmful consequences.
misconceptions potentially
, DOV
Pharmaceutical,
Inc. The
Company anticipates that Phase III clinical trials evaluating low
doses
of doxepin for insomnia will begin in mid 2005.S.impulse epidemiology
The trial is being conducted under a U. 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 collaborations as required
with pharmaceutical partners;
* 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
. Opioid receptor antagonists
such as nalmefene help to interrupt neurochemical reward and
reinforcement
, leading to a reduction in craving. In
a study evaluating oral nalmefene for the treatment of alcoholism
it
was observed that patients administered the drug experienced a
spontaneous decline in the number
of cigarettes smoked.antisocial steal
DOV believes that such a "broad spectrum" antidepressant could represent a
breakthrough in the treatment of 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.
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. Nalmefene is a specific and
selective
opioid receptor antagonist. as a potential treatment for impulse control
disorders (ICDs). This clinical
observation was the basis for the patent and I am encouraged that
Somaxon intends to investigate
the potential of oral nalmefene to
treat the major health problem of nicotine dependence," commented
Barbara Mason, Ph. Professor of Neuropharmacology/Molecular and
Experimental Medicine at Scripps
Research Institute.
Pathological gambling and other ICDs represent a significant unmet
medical
need as there is no approved drug therapy to treat these
disorders.potentially harmful
DOV Initiates Phase I Trial With
DOV 102 677 for Depression
Phil Skolnick, DOV's Senior Vice President, Research and Chief
Scientific
Officer, stated, "DOV 102,677 is the second compound from our
internal preclinical discovery program
to enter the clinic, with DOV 21,947
the first., or Merck, in September 2004.Somaxon Pharmaceuticals
Licenses U.S. Rights to the Use of Oral Nalmefene from University of Miami for the Treatment of Nicotine
Dependence
epidemiology kleptomania
J. Based upon preclinical studies,
DOV 102,677 has potential utility in the treatment
of depression, attention
deficit disorder and obesity. We are excited to advance this compound into
the clinic because it
both underscores the robustness of our discovery programs and validates our
strategy of relying, in part, on our internal discovery effort to fuel our
pipeline. DOV 102
,677 is related to DOV
216,303 and DOV 21,947, the two clinical-stage triple reuptake inhibitors
licensed
to a subsidiary of Merck + Co. Pathological
gambling is designated as an Impulse Control Disorder
which also
includes pyromania, kleptomania, and intermittent explosive disorder. Other UM
centers
of excellence include the Diabetes Research Institute, the
UM/Sylvester Comprehensive Cancer Center
, and The Miami Project to
Cure Paralysis.epidemiology antisocial
S.
About Somaxon Pharmaceuticals
Headquartered
in San Diego, Somaxon Pharmaceuticals is a specialty
pharmaceutical company focused on developing
and commercializing
products for the treatment of neuropsychiatric disorders.
The Company also
has in-licensed the worldwide rights to the use
of acamprosate, a GABA-A agonist and NMDA antagonist
, for the
treatment of movement disorders and other conditions and is initiating
product development
work on this compound. The inclusion of forward-looking
statements should not be regarded as a representation
by Somaxon that
any of its plans will be achieved.html
impulse epidemiology
Working overtime to stay the Web's best reference!
-> Show SiteSeek's List of Web Sites For This Topic (Not Yet Peer Reviewed)
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)