Regulatory News:
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.