EpiCept Receives Permission to File Ceplene® NDA

EpiCept Receives Permission to File Ceplene® NDA

No New Pivotal Clinical Data Required for Submission 

NDA Filing Expected Second Half of This Year 


TARRYTOWN, N.Y.--(BUSINESS WIRE)--  

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that
the U.S. Food and Drug Administration (FDA) indicated that the Company has the
necessary pivotal data to file a New Drug Application (NDA) for Ceplene®
(histamine dihydrochloride) in conjunction with interleukin-2 (IL-2) as a
remission maintenance treatment of acute myeloid leukemia (AML). At a pre-NDA
meeting held last week, the FDA provided guidance that it would accept the
clinical data along with other analyses, some of which had been submitted as
part of the Ceplene® Marketing Authorization Application (MAA), which was
approved in Europe in October 2008. 

At the pre-NDA meeting, the FDA requested that EpiCept provide additional
information to the submission package. The requested information includes
statistical data further supporting the incremental effectiveness of Ceplene®
given in conjunction with low-dose IL-2 and data showing the lack of significant
efficacy of IL-2 as a monotherapy for remission maintenance of AML. The FDA also
requested data supporting Leukemia-Free Survival (LFS) as an appropriate
endpoint in the pivotal Phase III study for Ceplene®, as compared with Overall
Survival. Much of the requested data already has been generated in connection
with the European MAA filing. 

“We are pleased with the outcome of the pre-NDA meeting. We will be turning our
immediate attention to assessing the requirements to submit the NDA in the
shortest timeframe possible so as to not deny this unique therapy to AML
patients. We are targeting filing the NDA in the second half of this year,”
stated Jack Talley, President and Chief Executive Officer of EpiCept. “This is
an important advance of our commercial strategy. Ceplene® is the first and only
approved immunotherapy shown to significantly prolong LFS and prevent relapse
among AML patients in first remission. We continue to make progress with our
partner selection process for Ceplene® in Europe, where the drug has full
marketing approval, and we will continue to diligently pursue regulatory
approval for this important therapy in North America. Our intent remains
steadfast that with the approval of Ceplene® in North America, we will build a
fully integrated commercial organization centered around hematology to market
Ceplene® and complementary products.” 

In December 2008, EpiCept announced that it had received permission from Health
Canada to proceed with a New Drug Submission (NDS) filing for Ceplene® for the
treatment of AML. The NDS filing is expected to occur prior to the NDA filing.
Decisions by regulators on both applications are expected in 2010. 

About Ceplene® 

Ceplene® is EpiCept's proprietary product approved in the European Union for
maintenance therapy for adult patients with AML in first remission. 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. In October 2008, Ceplene®
received full marketing approval in the European Union for maintenance therapy
and prevention of relapse in adult patients with AML in first remission. 

About Acute Myeloid Leukemia (AML) 

AML is the most common type of leukemia in adults. Once diagnosed with AML,
patients typically receive induction and consolidation chemotherapy, with the
majority achieving complete remission. However, about 70-80% of patients who
achieve first remission will relapse, with the median time in remission before
relapse being only 12 months. Less than 15% of relapsed patients survive
long-term. 

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
Ceplene®, a cytokine immunomodulator that recently received marketing
authorization in Europe for the remission maintenance of AML patients, and
several pain therapies in clinical development. Two oncology drug candidates
currently in clinical development that were discovered using in-house 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 U.S. or Canada, the risk that Ceplene® will not
be launched in Europe in the first half of 2009 or achieve significant
commercial success, the risk that we are unable to find a suitable marketing
partner for Ceplene® on attractive terms, a timely basis or at all, the risk
that any required post-approval clinical study will not be successful, the risk
that we will not be able to maintain our final regulatory approval or marketing
authorization, the risk that we may not realize our anticipated cost savings,
the risks associated with the adequacy of our existing cash resources, 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 us in default or that
our secured lender would seek to sell our assets, the risk that our securities
may be delisted by The Nasdaq Capital Market or the OMX Nordic Exchange and that
any appeal of the delisting determination may not be successful, the risk that
Myriad's development of Azixa™ 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 we will not be able to find a buyer for
our ASAP technology, the risk that clinical trials for NP-1, including our
current clinical trial in PHN, or EPC-2407 will not be successful, the risk 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 we will
not obtain approval to market any of our other product candidates, the risks
associated with our 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 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:
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