EpiCept Corporation Receives Scientific Advice from European Medicines Agency for AmiKet™ CIPN Program
Requirements Are Consistent with FDA Guidance
TARRYTOWN, N.Y.--(BUSINESS WIRE)--
Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
today announced that it has received formal scientific advice from the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) for the clinical and nonclinical development and
subsequent Marketing Authorization Approval (MAA) filing of AmiKet™
(amitriptyline 4%, ketamine 2%) for the treatment of
chemotherapy-induced peripheral neuropathy (CIPN). AmiKet™ is a topical
cream intended for the treatment of peripheral neuropathic pain. In
general the CHMP's requirements are closely aligned with the recent
guidance given EpiCept by the U.S. Food and Drug Administration (FDA).
In its written advice the CHMP recommended that the proposed clinical
program consist of a single 12-week, four-arm, factorial-designed trial
in CIPN that would seek to demonstrate AmiKet™'s superiority compared
with placebo and with each of the component drugs of AmiKet™,
amitriptyline and ketamine. An additional two-arm efficacy study in CIPN
or another neuropathy is required to complete the clinical requirements
of the application. The advice provided a summary of the additional
nonclinical program requirements to file an MAA, which included a 90-day
dermal toxicity study in a non-rodent species, a dermal phototoxicity
study in a rodent and an ocular toxicity study.
EpiCept has reported statistically significant positive results in the
treatment of pain from post-herpetic neuralgia in several Phase II
studies, the non-inferiority of AmiKet™ compared with gabapentin in
another placebo-controlled study and a positive trend in the treatment
of pain in a diabetic neuropathy Phase II study.
Jack Talley, EpiCept President and CEO, commented, "We are particularly
pleased that the guidance we received from the CHMP is consistent with
the guidance we received from the FDA a few months ago. We are now able
to design a Phase III development program that will fulfill the
requirements of filing both the New Drug Application (NDA) in the U.S.
and the MAA in Europe, which will possibly reduce costs and shorten the
development timetable. Further, we believe receipt of the CHMP advice
will facilitate SunTrust Robinson Humphrey's efforts to conclude a
strategic transaction to move AmiKet™ into its final phase of
development."
In January 2012 EpiCept announced that it had engaged SunTrust Robinson
Humphrey, Inc. to assist in exploring strategic alternatives to maximize
the commercial opportunity of AmiKet™. The engagement is focused on the
identification and implementation of a strategy designed to optimize
AmiKet's value for the Company's shareholders.
About AmiKet™
AmiKet™ is a 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 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 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.
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 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 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
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 the
development of our other apoptosis product candidates will not be
successful, 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 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 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 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
Source: EpiCept Corporation
News Provided by Acquire Media
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