EpiCept’s AmiKet™ Receives Fast Track Designation from FDA


TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))--
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
crolibulinTMwill not be successful, the risk that AmiKet™ or crolibulinTMwill
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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
sec.gov&esheet=50232570&lan=en
-US&anchor=www.sec.gov&index=1&md5=571d3ed77498d38a79215b4cbcf9de54) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2
F 
www.epicept.com&esheet=50232570&lan=en
-US&anchor=www.epicept.com&index=2&md5=2b5f517044ce65de5d37c5f20f1a831f). 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

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