EpiCept Announces Ceplene® Approved for Marketing in Israel

EpiCept Announces Ceplene® Approved for Marketing in Israel

Additional Marketing Approval Applications Anticipated in 2011

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today announced that the Israeli Ministry of Health has approved the
marketing application for Ceplene®, indicated for remission maintenance
and prevention of relapse in adult patients with Acute Myeloid Leukemia
(AML) in first remission. Megapharm Ltd. is EpiCept's partner in Israel
and upon Ministry of Health approval of labeling and other technical
matters the company is expected to launch Ceplene® in the first quarter
of 2011.

EpiCept also anticipates that new marketing applications for Ceplene®
will be filed in several non-EU European and Pacific Rim countries in
early 2011 by its marketing partner Meda AB.

Jack Talley, EpiCept President and CEO commented: “We are delighted that
with this approval doctors in Israel will be able to prescribe Ceplene®
for their patients who are in first AML remission. Some of these doctors
have worked with us for many years to help obtain marketing approval in
the European Union, so we are especially gratified that their efforts
will allow them to use Ceplene® in their own medical practices. We also
look forward to further expanding the number of countries in which
Ceplene® is available through the new marketing applications expected to
be filed by Meda next year.”

About Ceplene

Ceplene® is approved in the European Union and is indicated for
remission maintenance therapy and prevention of relapse in adult
patients with Acute Myeloid Leukemia (AML), one of four types of
leukemia. Ceplene® is used together with low dose Interleukin-2. The
prevalence for AML in the EU is about 41,000 patients and over 16,000
new cases are diagnosed every year. While current induction and
consolidation treatments are successful in inducing complete remission
for the majority of AML patients, this remission is generally
short-lived. After achieving complete remission most patients will
suffer a relapse within one year. In an international, multicenter,
open-label, randomized Phase III study, Ceplene® met its primary
endpoint of prolonging leukemia-free survival for AML patients in
remission. The difference between the treated and control group was
highly statistically significant (p<0.008). A recently-completed subset
analysis of patients that were treated aggressively with consolidation
therapy before being randomized into the Phase III trial demonstrated a
difference in overall patient survival in favor of Ceplene®/IL-2 versus
standard of care (p-value = 0.07, with a median overall benefit of 36
months), suggesting that statistically significant improved overall
survival could be achieved in an adequately powered clinical trial.

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 product is Ceplene®, approved in the EU for the remission
maintenance and prevention of relapse in adult patients with Acute
Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial
is scheduled to commence in 2011. The Company has two 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 EpiCept™ NP-1, 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
that 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, 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 future financing will not successfully close or that the
proceeds thereof will be materially less than anticipated, 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 EpiCept™ NP-1 or
crolibulinTM will not be successful, the risk that EpiCept™ NP-1 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 EpiCept™ NP-1 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; the risk that
our securities may be delisted from Nasdaq; 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.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3o
DMTEzM2pvaWgxBHBvcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15
t064n6f%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlin
k%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526esheet%3D6170045%25
26lan%3Den_US%2526anchor%3Dwww.sec.gov%2526index%3D2%2526md5%3D61ec7b720
44301e411e3335754ee5c07&esheet=6552131&lan=en-US&anchor=www.sec.gov&inde
x=1&md5=746b8170b283a2c3e3f4b1755decef59) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http
%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3
DX3oDMTE2OGhhcWs4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2F
SIG%3D1659oglun%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3D
smartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.epicept.com%2526esheet%
3D6170045%2526lan%3Den_US%2526anchor%3Dwww.epicept.com%2526index%3D3%252
6md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6552131&lan=en-US&anchor=
www.epicept.com&index=2&md5=f2d694df7dd54216db582a2fcddb5fd3). 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 (rcook@epicept.com)
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com (gregory.kelley@fkhealth.com)
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com (kgolodetz@lhai.com)
or
Bruce Voss, 310-691-7100
bvoss@lhai.com (bvoss@lhai.com)