Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that it has filed a New Drug Submission (NDS) with Health
Canada for Ceplene® (histamine dihydrochloride) for the
treatment of acute myeloid leukemia (AML) patients in first complete
remission. Health Canada typically accepts or refuses an NDS and
designates review status within forty-five days of filing. If accepted,
the customary timeframe for completion of review and an approval
decision is within one year.
"The filing of the NDS for Ceplene® with Health Canada is a
another key milestone for EpiCept and an important step in our North
American regulatory strategy for this innovative new therapy,” stated
Jack Talley, President and Chief Executive Officer of EpiCept. "We
anticipate that we will also be in the position to file a New Drug
Application with the U.S. Food and Drug Administration towards the end
of this year, contingent upon planned discussions with the FDA.”
Ceplene® is currently 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 announced that it had launched a named patient
program for Ceplene® in partnership with IDIS and under which
physicians in all major global markets excluding the U.S. can prescribe
Ceplene® to patients.
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 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 EpiCeptTM 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 AzixaTM will not be successful,
the risk that AzixaTM 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 EpiCeptTM
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 EpiCeptTM
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.