EpiCept Corporation Receives Scientific Advice from European Medicines Agency for AmiKet™ CIPN Program

  EpiCept Corporation Receives Scientific Advice from European Medicines
  Agency for AmiKet™ CIPN Program

                Requirements Are Consistent with FDA Guidance

Business Wire

TARRYTOWN, N.Y. -- June 04, 2012

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 crolibulin^TM will not be successful, the risk that AmiKet™ or
crolibulin^TM 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

Contact:

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
 
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