EpiCept Corporation Receives Finalized FDA Guidance for AmiKet™ Phase III CIPN Program and Regulatory Strategy

EpiCept Corporation Receives Finalized FDA Guidance for AmiKet™ Phase III CIPN
Program and Regulatory Strategy

Clear Pathway for NDA Filing Identified; Fast Track Application Encouraged

TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))-- Regulatory
News:

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today
announced that it received further encouraging guidance for the Phase III
clinical and nonclinical development and subsequent New Drug Application (NDA)
filing of AmiKet™ (amitriptyline 4%, ketamine 2%) in the treatment of
chemotherapy- induced peripheral neuropathy (CIPN) based on the issuance of the
final minutes of the Company’s meeting with the U.S. Food and Drug
Administration (FDA) in December 2011. AmiKet™ is a prescription topical cream
intended for the treatment of peripheral neuropathic pain. In the final meeting
minutes recently received by EpiCept, the FDA acknowledged that painful symptoms
due to CIPN represent a significant unmet medical need and encouraged EpiCept to
apply for Fast Track designation. Further, the FDA waived several expensive and
time consuming non-clinical toxicology studies, and indicated that a single
four-arm factorial trial might suffice for regulatory approval if combined with
other pivotal data in another neuropathy such as diabetic peripheral neuropathy.

The key element of the proposed Phase III clinical program is a 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. EpiCept intends to submit the protocol
for this trial to the FDA via a Special Protocol Assessment (SPA). An additional
two-arm efficacy study in another painful peripheral neuropathy may be performed
as an alternative strategy to a second factorial-designed trial for the NDA
filing, which could potentially lead to a broader label in the treatment of
peripheral neuropathic pain. In addition to the positive outcome previously
reported for AmiKet™ in CIPN, 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 very pleased that the
meeting minutes confirmed our belief that the FDA’s requirements for the
clinical and nonclinical programs to support an AmiKet™ NDA filing are
achievable. We consider this a very positive outcome that will likely benefit
AmiKet’s market opportunity and time to NDA filing. Further, we believe this
will facilitate SunTrust Robinson Humphrey’s efforts to identify potential
acquirers or strategic partners to advance AmiKet™ towards approval and
commercialization in the United States. This program may also facilitate the
filing of a marketing authorization application (MAA) for the European Union.”

The meeting minutes included a summary of the nonclinical program requirements
to file an NDA, which notably included only a single dermal carcinogenicity
study. The dermal photo-irritation/toxicity assessment may be waived, provided
dermal photo-irritation is assessed in the clinical program. A COMET assay
(Single Cell Gel Electrophoresis to detect DNA damage) study is required prior
to initiation of the long-term open label clinical safety study.

Earlier this month, EpiCept announced that it had engaged 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 designed to optimize AmiKet’s
value for the Company’s shareholders.

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 cancer and pain. 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. 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.

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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cts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%25252F%2
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S&anchor=www.sec.gov&index=1&md5=bfb863761112a803be35af1c2b2a3142) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2
Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3DX3oDMTE2OGhhcWs
4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2FSIG%3D1659oglun%2F**http
%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%
25252F%25252Fwww.epicept.com%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dw
ww.epicept.com%2526index%3D3%2526md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=5
0141321&lan=en-US&anchor=www.epicept.com&index=2&md5=454563f949e4cda4b90d2a82614
ed562). 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