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

Requirements Are Consistent with FDA Guidance
TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))-- 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 crolibulinTMwill not be successful, the risk that AmiKet™
or crolibulinTMwill 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fus.
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www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2
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-US&anchor=www.epicept.com&index=2&md5=df52562e5d170f468d828032bc026979). 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