EpiCept Announces Non-Binding Opinion by European Regulatory Authority on Ceplene Marketing Application

EpiCept Announces Non-Binding Opinion by European Regulatory Authority on
Ceplene Marketing Application

Final Opinion from EMEA Expected Next Month

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

    EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that the Company recently presented at the Oral Explanation
meeting to the European Committee for Medicinal Products for Human Use
(CHMP), the scientific committee of the European Medicines Agency
(EMEA), regarding the remaining outstanding issues on the marketing
authorization application (MAA) for Ceplene(R) (histamine
dihydrochloride), which is intended to be indicated for the
maintenance of remission and prevention of relapse of patients with
Acute Myeloid Leukemia (AML) in first remission. Ceplene was
designated as an orphan medicinal product in the European Union on
April 11, 2005 in respect of this indication.

    A non-binding trend vote taken after the Oral Explanation
indicated that a slight majority of the votes by CHMP members was not
in favor of recommending a positive opinion. The majority view of the
CHMP considered that the data presented in the application, while
supportive of the product's efficacy and safety in AML, the indication
for which approval was sought, should be confirmed by further clinical
data from an additional, replicate study. Discussions by CHMP members
of the MAA noted findings from a 2003 study of Ceplene/IL-2 (at a
higher dose) in malignant melanoma (a metastatic solid tumor disease
with a high tumor burden), in which Ceplene failed to meet its primary
endpoints. By contrast, AML patients in first remission have a
microscopically and cytogenetically undetectable tumor burden (minimal
residual disease) and are ideal candidates for Ceplene/IL-2
immunotherapy."We are disappointed with the results of this non-binding trend
vote by the CHMP, which we believe are inconsistent with the strength
of the data we submitted on Ceplene for AML," remarked Jack Talley,
President and CEO of EpiCept. "We are particularly disappointed that
AML patients, for whom this treatment is intended, may be denied the
opportunity to extend their disease-free survival as currently no
approved treatment is available which will maintain remission in these
patients. We believe our application for this Orphan Drug adequately
demonstrated the benefits of Ceplene in prolonging leukemia free
survival when used in conjunction with low-dose interleukin-2 (IL-2).
The MAA is supported by data sufficient for approval under the
regulations, specifically, approval based on a single pivotal trial
where the drug if approved would satisfy a significant unmet medical
need. As we head towards a final vote on the MAA next month, we are
assessing potential options to gain approval and, if the final opinion
is negative, whether that decision should be appealed."

    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 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 Ceplene
will not receive regulatory approval or marketing authorization in the
EU or that any appeal of an adverse decision in the EU will not be
successful, the risk that Ceplene, 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 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 EPC 2407 will
not be successful, that NP-1 or EPC 2407 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 EpiCept
will not obtain approval to market any of its 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; competition;
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
             or
             Media:
             Feinstein Kean Healthcare
             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