EpiCept Corporation Announces Health Canada Accepts Ceplene(R) Application for Review

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT | Quote | Chart | News | PowerRating) today
announced that Health Canada has accepted for review the Company's New
Drug Submission (NDS) for Ceplene(R) (histamine
dihydrochloride) for the remission maintenance of acute myeloid leukemia
(AML) patients in first complete remission. Health Canada's performance
target for the completion of review and a decision is within 300 days.

"We are pleased to have completed another key milestone in our North
American regulatory strategy for Ceplene(R)," stated Jack
Talley, President and Chief Executive Officer of EpiCept. "As the next
step in this process, we are focused on the filing of a New Drug
Application for Ceplene(R) with the U.S. Food and Drug
Administration for AML remission maintenance. As previously stated, we
intend to utilize the approval of Ceplene(R) in order to
establish a fully integrated specialty pharmaceutical company focused in
hematology in North America."

EpiCept also announced today that Israel's Ministry of Health has
accepted a marketing application for Ceplene(R) for the
remission maintenance of AML patients in first remission. The Company's
distribution and marketing partner for Ceplene(R) in Israel,
Megapharm Ltd., filed the application and will market Ceplene(R)
upon approval. A decision on this application is anticipated late next
year.

Ceplene(R) is approved in the European Union for the remission
maintenance and prevention of relapse in patients with AML in first
remission. The company is continuing negotiations with prospective
partners for the European marketing rights to Ceplene(R). In
June 2009 EpiCept launched a named patient program for Ceplene(R) in
partnership with IDIS under which physicians in all major global markets
excluding the U.S. can prescribe Ceplene(R).

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(R), which has been granted
full marketing authorization by the European Commission for the
remission maintenance and prevention of relapse in adult patients with
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(TM)
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, 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 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(R) will not
receive regulatory approval or marketing authorization in the United
States or Canada, the risk that Ceplene(R) will not be launched
or achieve significant commercial success, the risk that we are unable
to find a suitable marketing partner for Ceplene(R) on
attractive terms, a timely basis or at all, the risk that any required
post-approval clinical study for Ceplene(R) will not be
successful, the risk that we will not be able to maintain our final
regulatory approval or marketing authorization for Ceplene(R),
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 our securities may be delisted by The
Nasdaq Capital Market and that any appeal of the delisting determination
may not be successful, 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 we will not be able to
find a buyer for our ASAP technology, the risk that clinical trials for
EpiCept(TM) NP-1 or crinobulin will not be successful, the risk
that EpiCept(TM) NP-1 or crinobulin 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(TM)
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
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.

SOURCE: EpiCept Corporation

EpiCept Corporation: 
Robert W. Cook, 914-606-3500 
mail@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

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