Preferential action on DA reuptake transporter? Wouldnt that create addiction potential?
DOV Initiates Phase I Trial With DOV 102,677 for Depression
2005-02-24 07:30 (New York)
HACKENSACK, N.J., Feb. 24 /PRNewswire-FirstCall/ -- DOV Pharmaceutical,
Inc. (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. DOV 102,677 is the third of DOV's triple reuptake
inhibitors to enter the clinic. 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. The trial is being conducted under a U.S. investigational
new drug application (IND).
No currently marketed antidepressant inhibits the reuptake of all three
neurotransmitters linked to depression: serotonin, norepinephrine and
dopamine. 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.
DOV believes that such a "broad spectrum" antidepressant could represent a
breakthrough in the treatment of depression. Based upon preclinical studies,
DOV 102,677 has potential utility in the treatment of depression, attention
deficit disorder and obesity.
Dr. 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. 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. 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."
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. 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. Inc., or Merck, in September 2004. 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. Merck has rights of first offer and
refusal if the Company determines to commercialize DOV 102,677 for depression
or anxiety. 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. 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.
Dr. 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.
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 six product candidates undergoing clinical
development that address therapeutic indications with significant unmet needs.
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.
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.
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:
* 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.
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.
SOURCE DOV Pharmaceutical, Inc.
CONTACT:
Company - Barbara Duncan, Chief Financial Officer, DOV Pharmaceutical, Inc., +1-
201-968-0980; or Corporate Communications - Kathleen Eppolito, Scientia
Communications, Inc., +1-718-281-1809
-0- Feb/24/2005 12:30 GMT
DOV Initiates Phase I Trial With DOV 102,677 for Depression
2005-02-24 07:30 (New York)
HACKENSACK, N.J., Feb. 24 /PRNewswire-FirstCall/ -- DOV Pharmaceutical,
Inc. (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. DOV 102,677 is the third of DOV's triple reuptake
inhibitors to enter the clinic. 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. The trial is being conducted under a U.S. investigational
new drug application (IND).
No currently marketed antidepressant inhibits the reuptake of all three
neurotransmitters linked to depression: serotonin, norepinephrine and
dopamine. 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.
DOV believes that such a "broad spectrum" antidepressant could represent a
breakthrough in the treatment of depression. Based upon preclinical studies,
DOV 102,677 has potential utility in the treatment of depression, attention
deficit disorder and obesity.
Dr. 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. 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. 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."
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. 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. Inc., or Merck, in September 2004. 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. Merck has rights of first offer and
refusal if the Company determines to commercialize DOV 102,677 for depression
or anxiety. 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. 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.
Dr. 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.
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 six product candidates undergoing clinical
development that address therapeutic indications with significant unmet needs.
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.
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.
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:
* 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.
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.
SOURCE DOV Pharmaceutical, Inc.
CONTACT:
Company - Barbara Duncan, Chief Financial Officer, DOV Pharmaceutical, Inc., +1-
201-968-0980; or Corporate Communications - Kathleen Eppolito, Scientia
Communications, Inc., +1-718-281-1809
-0- Feb/24/2005 12:30 GMT
