EpiCept's Ceplene® Highlighted in Two 2008 European Union Drug Approval Reports

EpiCept's Ceplene® Highlighted in Two 2008 European Union Drug Approval Reports 

TARRYTOWN, N.Y.--(BUSINESS WIRE)--EpiCept Corporation (Nasdaq and OMX Nordic
Exchange: EPCT) today announced that Ceplene® (histamine dihydrochloride) has
been highlighted in two separate reports issued recently reviewing 2008 drug
approvals in the European Union. One report, issued by the U.K. publication
Mednous, said that Ceplene® was one of 12 products “expected to confer major
public health benefits,” while the European Medicines Agency (EMEA), in its
summary of the annual report for 2008, stated, “Of the 66 medicines to receive a
positive opinion from the CHMP in 2008, those that are of particular note
include: the first medicine for use as a maintenance treatment in adults with
acute myeloid leukemia…” 

“We are gratified that Ceplene® has been recognized for its importance in
providing a clear benefit in prolonging leukemia-free survival and preventing
relapse among AML patients in first remission,” stated Jack Talley, President
and Chief Executive Officer of EpiCept. “We believe that Ceplene® is poised to
make a major contribution to the management of this deadly disease. As such, we
are making it available on a named patient basis essentially worldwide, with the
exception of the United States. In the United States we are continuing our
preparation of a New Drug Application or NDA for submission to the FDA." 

Ceplene® 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 several prospective partners for the European
marketing rights to Ceplene®. In June 2009 EpiCept launched a named patient
program for Ceplene® in partnership with IDIS under which physicians in all
major global markets excluding the U.S. can prescribe Ceplene®. 

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, 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® will not receive regulatory approval or
marketing authorization in the United States or Canada, the risk that Ceplene®
will not be launched in Europe in the second 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 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 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™ 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 EpiCeptTM NP-1 or crinobulin will
not be successful, the risk that EpiCept™ 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™ 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.

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