EpiCept Announces Fulfillment of Ceplene's Third European Post-Approval Commitment

EpiCept Announces Fulfillment of Ceplene's Third European Post-Approval
Commitment

EMA Agrees Confirmatory Trial Not Needed or Feasible

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

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT)
today provided an update on the post-approval commitments requested by
the European Medicines Agency (EMA) as part of its marketing
authorization for Ceplene® (histamine dihydrochloride). Ceplene is
approved in the EU for remission maintenance and prevention of relapse
in adults with Acute Myeloid Leukemia (AML) in first complete remission.
The EMA has notified EpiCept that it has accepted the conclusion of a
panel of prominent hematologists convened by the Company that it is not
feasible to conduct, in conjunction with cooperative groups in Europe
and/or the United States, a confirmatory Phase III study to evaluate the
safety and efficacy of Ceplene with low-dose interleukin-2 (IL-2) versus
a comparator arm of either no treatment or IL-2 alone. As a result, the
EMA now considers this post-approval commitment fulfilled.

In reaching its decision, the EMA accepted the consensus opinion of the
panel, which concluded, in part, that robust data on the safety and
efficacy of Ceplene in conjunction with low-dose IL-2 have already been
collected. A new clinical study of Ceplene/IL-2 in remission maintenance
for AML versus a comparator without demonstrated efficacy would raise
ethical and practical issues in obtaining required study approvals from
institutional ethics committees and institutional review boards.

EpiCept is continuing enrollment in its post-approval clinical trial
studying the effects of remission maintenance therapy with Ceplene/IL-2
on minimal residual disease (MRD) in adult patients with AML in first
complete remission. This open-label, multicenter study is also assessing
the quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2
by monitoring T-cell and natural killer cell phenotypes and their
functionality after the first and third treatment cycles. The study will
enroll up to 150 patients at approximately 30 centers across Europe with
sites in Sweden, Belgium, France, the U.K., Spain and Italy.

Commenting on the EMA's decision, Jack Talley, President and Chief
Executive Officer of EpiCept, said, “We are pleased that EMA officials
have agreed that obtaining data from a new confirmatory study versus a
comparator with unproven efficacy was not feasible. We intend to inform
other regulatory authorities, including Health Canada and the FDA, of
the EMA's conclusion during their respective reviews of the Ceplene
application for marketing approval. We expect to complete the
post-approval trial with Ceplene in 2011 and remain on track with our
plans to submit a New Drug Application to the U.S. Food and Drug
Administration during the current quarter.”

About Ceplene

Ceplene is indicated for remission maintenance therapy and prevention of
relapse in adult patients with Acute Myeloid Leukemia (AML). Ceplene is
used together with low dose Interleukin-2. AML is one of four major
types of leukemia. Approximately 16,000 new cases of AML are diagnosed
in Europe 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 statistically significant (p<0.008).

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, 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 two 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
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 Myriad, 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 crolibulin 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; 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&div=lhfhjagj
ii&url=http%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba
9_%3B_ylu%3DX3oDMTEzM2pvaWgxBHBvcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2Vj
Z292%2FSIG%3D15t064n6f%2F**http%253A%2Fcts.businesswire.com%2Fct%2FCT%25
3Fid%3Dsmartlink%2526url%3Dhttp%25253A%25252F%25252Fwww.sec.gov%2526eshe
et%3D6170045%2526lan%3Den_US%2526anchor%3Dwww.sec.gov%2526index%3D2%2526
md5%3D61ec7b72044301e411e3335754ee5c07&esheet=6310064&lan=en_US&anchor=w
ww.sec.gov&index=1&md5=acb377f26d0a9f2eea0aca3f3f46917a) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&div=lhfh
jagjii&url=http%3A%2F%2Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNN
fjba9_%3B_ylu%3DX3oDMTE2OGhhcWs4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3
ZXBpY2VwdGNv%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%3Dwww.epicept.com%25
26index%3D3%2526md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=6310064&la
n=en_US&anchor=www.epicept.com&index=2&md5=e8387a70093e51da1dd6a617b88d0
e3d). 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 Myriad Genetics, 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)