EpiCept Reports Regulatory Progress on Ceplene(TM)


TARRYTOWN, New York, September 18 /PRNewswire/ --

- Application for AML Remission Maintenance Therapy

- Advances on Schedule Following Meeting with EMEA

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today reported
that the assessment of its European Union centralized marketing authorization
application for its lead oncology product Ceplene(TM) is advancing according
to the anticipated regulatory timetable following a meeting yesterday.
Ceplene (histamine dihydrochloride) has demonstrated important clinical
benefit in the maintenance of remission for patients with Acute Myeloid
Leukemia (AML).

(Logo: http://www.newscom.com/cgi-bin/prnh/20020513/NYM112LOGO )

EpiCept's Marketing Authorization Application (MAA) for Ceplene has
reached the next important step in its assessment by the Committee for Human
Medicinal Products (CHMP). Specifically, EpiCept submitted full responses to
the Day 120 Consolidated List of Questions. EpiCept's staff and expert
consultants met on September 17 with EMEA officials and CHMP representatives
to discuss these responses. Included with the Day 120 response documentation,
EpiCept has provided data on Ceplene's effect on quality of life and on long
term follow up of at least five years on leukemia-free survival for AML
patients.

"We are pleased to have reached the latest regulatory milestone for
Ceplene in the EU, and to be closer to our goal of providing hematologists
with the first remission maintenance immunotherapy for AML patients," stated
Jack Talley, President and Chief Executive Officer of EpiCept. "EpiCept
outlined to the EMEA and CHMP representatives how the data package for
Ceplene supports approval. We look forward to working with the regulators to
complete their assessment. We are enthusiastic about the potential of
Ceplene, which in our pivotal trial increased the long-term, disease-free
survival of AML patients by more than 50%. Importantly, this significant
therapeutic benefit was achieved with a remarkably well-tolerated,
self-administered immunotherapy."

EpiCept's MAA submission for Ceplene is being assessed under the EU
centralized procedure, and if approved, will provide a marketing
authorization valid in all EU member states, along with Iceland,
Liechtenstein and Norway. The European Commission has previously granted
orphan drug status to Ceplene for use in the treatment of AML. If the
application for Ceplene continues to follow usual EU regulatory timelines,
the next milestone on Ceplene's path to approval is expected to be the CHMP
Day 180 list of outstanding issues, which EpiCept expects will be received in
the fourth quarter of 2007. EpiCept expects this to be followed by a
recommendation regarding approvability from the CHMP and a final decision by
the European Commission during the first half of 2008.

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 Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults. There are
approximately 47,000 AML patients in the EU, with 14,000 new cases occurring
each year. For the majority of AML patients, the prospects for long-term
survival are disappointing. Once diagnosed with AML, patients are treated
with toxic chemotherapies. Although approximately 75% of patients achieve a
complete remission, the leukemia frequently recurs (a "relapse"), usually
within 1-2 years. Despite follow-up treatment that may include very toxic
chemotherapy or bone marrow transplantation, only 10% to 20% of patients
survive long term after relapse. There are currently no proven treatments for
maintaining long-term remission for AML patients.

About EpiCept Corporation

EpiCept is focused on unmet needs in the treatment of pain and cancer.
EpiCept has a staged portfolio of pharmaceutical product candidates with
several pain therapies in late-stage clinical trials, and a lead oncology
compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a
Phase III trial; a marketing authorization application for this compound has
been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its
research and development team in San Diego is pursuing a drug discovery
program focused on novel approaches to apoptosis.

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 Ceplene, if approved, will not achieve significant
commercial success, the risk that Myriad's development of Azixa(TM)(i) will
not be successful, 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 our ASAP technology will not yield any successful product
candidates, the risk that clinical trials for NP-1 will not be successful,
that NP-1 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 reliance on additional outside financing to meet its
capital requirements, 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

(i) Azixa is a registered trademark of Myriad Genetics, Inc.

Web site: http://www.epicept.com

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