EpiCept Announces Opinion by European Regulatory Authority on Ceplene(R)

EpiCept Announces Opinion by European Regulatory Authority on Ceplene(R)

    TARRYTOWN, N.Y.--(BUSINESS WIRE)--March 20, 2008--Regulatory News:

    EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that the European Committee for Medicinal Products for Human
Use (CHMP), the scientific committee of the European Medicines Agency
(EMEA), has issued, as expected following the trend vote announced
last month, a negative opinion regarding the marketing authorization
application (MAA) for Ceplene(R) (histamine dihydrochloride) for the
remission maintenance and prevention of relapse of patients with Acute
Myeloid Leukemia (AML) in first remission. Ceplene is designated as an
orphan medicinal product in the European Union with respect to this
indication.

    In reaching this opinion, the CHMP stated that further data are
required to support the results from EpiCept's Phase III clinical
study of Ceplene. The CHMP indicated that data from the single pivotal
AML trial was not adequately statistically compelling. Specifically,
the CHMP seeks additional mechanistic data on Ceplene to elucidate
further the pharmacological rationale for the proposed use of
Ceplene(R) in conjunction with interleukin-2. The company believes
that sufficient pre-clinical mechanistic data has already been
supplied to the CHMP. EpiCept also believes that additional
mechanistic clinical data could be generated post-approval.
Importantly, based on input from the CHMP, EpiCept believes we will be
able to obtain approval without having to conduct an additional
confirmatory Phase III trial.

    There were no major safety concerns with the application. A
divergent opinion from the co-rapporteur indicated that the results of
the pivotal study were sufficiently robust to support full marketing
authorization in part due to the public health need for AML treatment.

    In accordance with the rules governing the European Centralized
procedure, EpiCept has already requested a re-examination of this
opinion through the appeal procedure. No formal decision will be taken
by the European Commission, as the European licensing authority, until
the appeal procedure has been completed. EpiCept intends to submit a
document setting out the "Detailed Grounds for Re-Examination" within
60 days of receipt of the negative opinion and expects its appeal
proceeding to take place in the third quarter of this year."While not surprising in light of the negative trend vote
announced last month, we are nonetheless disappointed at the opinion
reached by the CHMP," remarked Jack Talley, President and CEO of
EpiCept. "We believe the strength of the clinical data provided in our
application has amply demonstrated the benefits of Ceplene in
prolonging leukemia free survival and preventing relapse in AML
patients when used in conjunction with low-dose interleukin-2 (IL-2),
the only therapy ever to produce this degree of therapeutic benefit.
Ceplene's Phase III clinical trial results showed that it achieved a
greater than 50 percent improvement in long-term prognosis, in essence
conferring in excess of an extra year of life to these seriously-ill
patients. We remain optimistic that we will be successful in the
re-examination of our application and we will continue to be steadfast
in our efforts to bring this desperately needed therapy to AML
patients in Europe."

    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 14,000 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 pain and
cancer. 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 is
approaching a decision 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 our need to raise additional financing to continue to
meet our capital needs and our ability to continue as a going concern,
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; risks associated with prior material
weaknesses in our internal controls; 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.


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