EpiCept Files Re-Examination Documentation for Marketing Authorization of Ceplene(TM) in Europe

EpiCept Files Re-Examination Documentation for Marketing Authorization of
Ceplene(TM) in Europe

    TARRYTOWN, N.Y.--(BUSINESS WIRE)--May 27, 2008--Regulatory News:

    EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that it has submitted the documentation to support a
re-examination of its Marketing Authorization Application (MAA) in
Europe for Ceplene(TM) to the Committee for Medicinal Products for
Human Use (CHMP). Ceplene (histamine dihydrochloride) is intended for
the remission maintenance and prevention of relapse in patients with
Acute Myeloid Leukemia (AML) in first remission. The Company
anticipates that appeal proceedings in response to this filing will
take place in the third quarter of this year.

    During the last few months, EpiCept has received new written
support from key opinion leaders in hematology representing numerous
European countries, who have unanimously recommended the approval of
Ceplene in order to have immediate access to this therapy for their
patients. "We have met with many of Europe's leading hematologists and
have received overwhelming support for the approval of Ceplene in
Europe to address this critical unmet medical need for AML patients,"
said Stephane Allard, M.D., Chief Medical Officer of EpiCept.

    The comprehensive dossier detailing the grounds for re-examination
addresses the three remaining issues that formed the basis of the
negative opinion issued by the CHMP on March 19, 2008. EpiCept
believes that this dossier supplies ample and compelling evidence for
the approval of the MAA for Ceplene, and through this submissionaffirms to regulators that the MAA submitted:

    --  Provides a clear and strong pharmacological rationale for the
        use of Ceplene in conjunction with low dose interleukin-2 in
        this indication. Updated clinical pharmacological data have
        been added, which supplement the original MAA and are
        supported by rigorous and well-documented preclinical in vitro
        and in vivo studies, published in leading scientific journals.

    --  Includes updated data from our prior clinical trials that
        support Ceplene's pharmacologic rationale and mechanism of
        action. The data from the Phase III study have already clearly
        demonstrated the significant efficacy and the excellent safety
        of Ceplene in this indication;

    --  Presents statistically significant results through the
        inclusion of positive data from Ceplene's Phase II study and
        pivotal Phase III study. These data have undergone another
        independent statistical analysis performed by leading European
        biostatisticians who have validated the original analyses and
        have confirmed that the data are robust and that the results
        cannot be explained by chance.

    The Company also submitted in the dossier a signed consensus
statement from leading European AML experts from each of the major
European countries acknowledging the critical medical need for a safe
and effective remission maintenance therapy for AML patients and that
Ceplene when approved would be used in hematology clinical practice
for this disease. In addition, we submitted a signed consensus
statement from leading European biostatisticians attesting to the
consistency and robustness of the Phase III Ceplene data package."The approval of Ceplene, in conjunction with IL-2, would provide
AML patients in Europe with the first pharmaceutical therapy to
produce a clear benefit in prolonging leukemia free survival and
preventing relapse. Furthermore it is expected that an approval would
prevent relapse of this disease in nearly 1500 patients per year in
Europe, patients who have no other therapeutic alternative," remarked
Jack Talley, President and CEO of EpiCept. "We believe we have
completely addressed the concerns of the CHMP and are hopeful that the
CHMP appreciates the benefit-to-risk balance of Ceplene and grants a
marketing authorization for this important product."

    About Acute Myeloid Leukemia (AML)

    AML is the most common type of leukemia in adults. There are
approximately 40,000 AML patients in the EU, with 16,000 new cases
occurring each year. Once diagnosed with AML, patients are typically
treated with induction chemotherapy and consolidation therapy, with
the majority achieving complete remission. However, about 75-80% of
patients who achieve first remission will relapse, with the median
time in remission before relapse being only 12 months with current
treatments. Less than 5% of relapsed patients survive long term.

    About Ceplene

    Ceplene is EpiCept's registration-stage compound for the treatment
of AML. Ceplene is designed to protect lymphocytes responsible for
immune-mediated destruction of residual leukemic cells. Laboratory
research has demonstrated that Ceplene reduces formation of oxygen
radicals from phagocytes, inhibiting NADPH oxidase and protecting
IL-2-activated NK-cells and T-cells.

    About EpiCept Corporation

    EpiCept is focused on unmet needs in the treatment of cancer and
pain. The Company's broad portfolio of pharmaceutical product
candidates includes several pain therapies in clinical development and
a lead oncology compound for AML with demonstrated efficacy in a Phase
III trial; a marketing authorization application for this compound
recently received a negative opinion and is being re-examined in
Europe. In addition, EpiCept's ASAP technology, a proprietary live
cell high-throughput caspase-3 screening technology, can efficiently
identify new cancer drug candidates and molecular targets that
selectively induce apoptosis in cancer cells. Two oncology drug
candidates currently in clinical development that were discovered
using this technology have also 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, contains 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 EpiCept's 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 our appeal
of the negative opinion regarding the MAA for Ceplene(R) will not be
successful and that Ceplene(R) will not receive regulatory approval or
marketing authorization in the EU, the risk that Ceplene(R), if
approved, will not achieve significant commercial success, the risks
associated with the adequacy of our existing cash resources and our
need to raise additional financing to continue to meet our capital
needs 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 or that we may default on our loans or
that our lenders may declare the Company in default or that our
secured lender would seek to sell our assets, the risks that we may
not be able to extend the maturity of our euro-denominated loan, the
risk that the Company's securities may be delisted by The Nasdaq
Capital Market and that any appeal of the delisting determination may
not be successful, the risk that Myriad's development of Azixa(TM)
will not be successful, the risk that Azixa(TM) 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 our
ASAP technology will not yield any successful product candidates, the
risk that clinical trials for NP-1 or EPC2407 will not be successful,
the risk that NP-1 or EPC2407 will not receive regulatory approval or
achieve significant commercial success, 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 EpiCept's periodic reports,
including its 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 EpiCept's
filings which are available at www.sec.gov or at www.epicept.com. 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.

    EPCT-GEN*Azixa is a registered trademark of Myriad Genetics, Inc.


EpiCept Corporation
             Robert W. Cook, (914) 606-3500
             rcook@epicept.com
             or
             Media:
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             Greg Kelley, (617) 577-8110
             gregory.kelley@fkhealth.com
             or
             Investors:
             Lippert/Heilshorn & Associates
             Kim Sutton Golodetz, (212) 838-3777
             kgolodetz@lhai.com
             or
             Bruce Voss, (310) 691-7100
             bvoss@lhai.com