EpiCept's AmiKet™ Receives Fast Track Designation from FDA
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
announced today that AmiKet™ (amitriptyline 4%, ketamine 2% cream) has
been granted Fast Track designation by the U.S. Food and Drug
Administration (FDA). AmiKet™ is the Company's late-stage product for
the treatment of neuropathic pain associated with chemotherapy-induced
peripheral neuropathy (CIPN) in patients previously treated with
taxane-based chemotherapy.
The FDA's Fast Track program is designed to facilitate the development
and expedite the review of drugs intended to treat serious or
life-threatening conditions and address unmet medical needs. According
to the FDA, products with a Fast Track designation oftentimes receive
priority review, which may reduce the standard review time by half. The
Fast Track designation also allows for more frequent interactions with
the FDA during the drug development process.
"We believe the FDA Fast Track designation is confirmation of the
pressing need for therapies to treat neuropathic pain associated with
CIPN," said Jack Talley, President and Chief Executive Officer of
EpiCept. "We expect the receipt of this designation will prove to be
highly valuable in our current partnering efforts for AmiKet™."
EpiCept previously announced the engagement of SunTrust Robinson
Humphrey to assist in exploring strategic alternatives to maximize the
commercial opportunity of AmiKet™. The engagement will focus on the
identification and implementation of a strategy to optimize AmiKet's
value for the Company's stockholders.
About AmiKet™
AmiKet™ is a prescription, topical analgesic cream containing
amitriptyline 4% and ketamine 2% designed to provide relief from
neuropathic pain, which affects more than 15 million people in the U.S.
alone. In the first half of 2011, EpiCept announced positive results
from a National Cancer Institute-sponsored study evaluating the efficacy
and safety of AmiKet™ in chemotherapy-induced peripheral neuropathy
(CIPN), a painful condition that frequently occurs following systemic
chemotherapy and that may interrupt, delay or even prevent completion of
potentially curative chemotherapy regimens. A safe and effective
therapeutic option for neuropathic pain associated with CIPN would
address a significant unmet medical need.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of pain and cancer. The
Company's pain portfolio includes AmiKet™, a prescription topical
analgesic cream in late-stage clinical development designed to provide
effective long-term relief of pain associated with peripheral
neuropathies. The Company's lead oncology product is Ceplene®,
which has been granted full marketing authorization by the European
Commission for the remission maintenance and prevention of relapse in
adult patients with Acute Myeloid Leukemia (AML) in first remission. The
Company has other oncology drug candidates currently in clinical
development that were discovered using in-house technology and have been
shown to act as vascular disruption agents in a variety of solid tumors.
In January 2012, EpiCept engaged SunTrust Robinson Humphrey to assist
the Company in exploring strategic alternatives to maximize the
commercial opportunity of AmiKet™ for the treatment of CIPN following
taxane-based therapy. The engagement is focused on the identification
and implementation of a strategy designed to optimize AmiKet's value for
the Company's stockholders, which includes the evaluation of potential
transactions involving the sale of the Company.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
which express plans, anticipation, intent, contingency, goals, targets,
future development and are otherwise not statements of historical fact.
These statements are based on our current expectations and are subject
to risks and uncertainties that could cause actual results or
developments to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Factors that may cause actual results or developments to
differ materially include: the risk that we will not be able to find a
partner to help conduct the Phase III trials for AmiKet™ on attractive
terms, a timely basis or at all, the risk that Ceplene® will
not receive regulatory approval or marketing authorization in the United
States or Canada, the risk that Ceplene® will not achieve
significant commercial success, the risk that any required post-approval
clinical study for Ceplene® will not be successful, the risk
that we will not be able to maintain our final regulatory approval or
marketing authorization for Ceplene®, the risk that Azixa™
will not receive regulatory approval or achieve significant commercial
success, the risk that we will not receive any significant payments
under our agreement with Myrexis, the risk that clinical trials for
AmiKet™ or crolibulinTM will not be successful, the risk that
AmiKet™ or crolibulinTM will not receive regulatory approval
or achieve significant commercial success, the risk that the development
of our EP1013 product candidate will not be successful, the risk that
our other product candidates that appeared promising in early research
and clinical trials do not demonstrate safety and/or efficacy in
larger-scale or later-stage clinical trials, the risk that we will not
obtain approval to market any of our product candidates, the risks
associated with the adequacy of our existing cash resources and our
ability to continue as a going concern, the risks associated with our
ability to continue to meet our obligations under our existing debt
agreements, the risks associated with dependence upon key personnel, the
risks associated with reliance on collaborative partners and others for
further clinical trials, development, manufacturing and
commercialization of our product candidates; the cost, delays and
uncertainties associated with our scientific research, product
development, clinical trials and regulatory approval process; our
history of operating losses since our inception; the highly competitive
nature of our business; risks associated with litigation; and risks
associated with our ability to protect our intellectual property. These
factors and other material risks are more fully discussed in our
periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and
other filings with the U.S. Securities and Exchange Commission. You are
urged to carefully review and consider the disclosures found in our
filings which are available at www.sec.gov
or at www.epicept.com.
You are cautioned not to place undue reliance on any forward-looking
statements, any of which could turn out to be wrong due to inaccurate
assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
# # #
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein
Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
LHA
Kim
Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce
Voss, 310-691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: EpiCept Corporation
News Provided by Acquire Media
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