EpiCept Files New Drug Application for Ceplene in AML

EpiCept Files New Drug Application for Ceplene in AML

Priority Review Requested

TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced
today that it has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for Ceplene® (histamine
dihydrochloride). EpiCept is seeking approval for Ceplene, administered
concomitantly with low-dose interleukin-2 (IL-2), for the remission
maintenance and prevention of relapse in patients with Acute Myeloid
Leukemia (AML) in first complete remission. Ceplene was approved for
this indication by the European Commission in October 2008 and is
currently available in the United Kingdom, Germany and Austria. Ceplene
is expected to be available throughout most of the European Union within
twelve months.

In its application, EpiCept requested priority review of the NDA. If
granted, priority review should result in an FDA decision date in late
December 2010. A decision with respect to the granting of priority
review must be made within 45 days of the filing date. Ceplene has been
granted orphan drug status in the United States, providing seven years'
marketing exclusivity from the NDA approval date.

“This filing is a very important milestone in our strategy for Ceplene,
and we are delighted to submit the NDA consistent with the timetable we
publicly announced,” stated Jack Talley, President and Chief Executive
Officer of EpiCept. “There are an estimated 9,000 deaths caused by AML
each year in the U.S. with no effective maintenance therapy currently
available. We believe that Ceplene, if approved, would favorably impact
the prognosis of patients with this lethal disease.”

The NDA submissiow:\6343714e.htmln is supported by a robust body of
evidence demonstrating a significant clinical benefit of Ceplene/IL-2
for remission maintenance in AML as compared with the standard-of-care,
which is no treatment. The pivotal Phase III study was conducted in ten
countries and included 320 randomized patients. The data demonstrated
that patients with AML in complete remission who received up to 18
months of treatment with Ceplene plus low-dose IL-2 experienced a
significantly longer period of leukemia-free survival (LFS) compared to
the standard-of-care. The difference between the treated and control
group was statistically significant (p<0.008). Ceplene is the only
medical therapy shown to extend LFS in this deadly form of leukemia.

At the request of the FDA, EpiCept has included in its NDA the results
of two meta-analyses to help isolate Ceplene's efficacy. The first
analysis confirmed the lack of clinical efficacy of IL-2 monotherapy as
remission maintenance for AML patients and the second demonstrated the
contribution of Ceplene in this indication when given in conjunction
with IL-2. These two meta-analyses were conducted by independent
statisticians and support the conclusions of the pivotal Phase III
trial.

If priority review is not granted, the FDA has up to 60 days to accept
the filing for review and assign an FDA decision date. In addition to
the NDA filing in the U.S., a New Drug Submission for Ceplene is
currently under active review by Health Canada, which is expected to
complete its review and provide a decision by the fourth quarter of
2010. Ceplene is also under review by the Israeli Ministry of Health. As
noted earlier, Ceplene is approved in thirty countries in Europe.

About EpiCept Corporation

EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of cancer and pain. The
Company's lead product is Ceplene®, which has been granted full
marketing authorization by the European Commission for the remission
maintenance and prevention of relapse in adult patients with Acute
Myeloid Leukemia (AML) in first remission. The Company has two oncology
drug candidates currently in clinical development that were discovered
using in-house technology and have been shown to act as vascular
disruption agents in a variety of solid tumors. The Company's pain
portfolio includes EpiCept™ NP-1, a prescription topical analgesic cream
in late-stage clinical development designed to provide effective
long-term relief of pain associated with peripheral neuropathies.

Forward-Looking Statements

This news release and any oral statements made with respect to the
information contained in this news release contain 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 our 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 United States or
Canada, the risk that Ceplene will not achieve significant commercial
success, the risk that any required post-approval clinical study for
Ceplene will not be successful, the risk that we will not be able to
maintain our final regulatory approval or marketing authorization for
Ceplene, the risks associated with the adequacy of our existing cash
resources 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, 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 clinical trials
for EpiCept NP-1 or crolibulinTM will not be successful, the risk that
EpiCept NP-1 or crolibulin will not receive regulatory approval or
achieve significant commercial success, the risk that we will not be
able to find a partner to help conduct the Phase III trials for EpiCept
NP-1 on attractive terms, a timely basis or at all, 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 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 our filings which are available at
www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
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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 (rcook@epicept.com)
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com (gregory.kelley@fkhealth.com)
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com (kgolodetz@lhai.com)
or
Bruce Voss, 310-691-7100
bvoss@lhai.com (bvoss@lhai.com)