Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced
today that it is discontinuing all drug discovery activities and
implementing an approximate 65% reduction in its workforce. EpiCept will
direct its resources toward the registration of Ceplene® in
North America and clinical development programs. When complete, these
actions are expected to reduce annual expenses by at least $5.5 million.
"This is a difficult decision and is largely attributable to the current
financing environment, but in taking these actions we will help ensure
that EpiCept has the resources to execute our development strategies for
our most advanced opportunities," stated Jack Talley, President and
Chief Executive Officer of EpiCept. "We are currently focused on
partnering Ceplene® in Europe and pursuing regulatory
approval of Ceplene in the U.S. and Canada. In addition, we look forward
to advancing our other drug candidates through key clinical trials, such
as our Phase 1b development program for EPC 2407 in patients with
advanced solid tumors and lymphomas."
Under the workforce reduction plan, most of the affected positions will
be eliminated immediately and the remainder will be eliminated over the
next three to six months. The Company expects to incur a one-time charge
during the first quarter of 2009 of approximately $2.5 million in
connection with the closing of the San Diego facility. EpiCept plans to
offer the proprietary ASAP drug discovery technology for sale or
partnering to an interested party.
Mr. Talley continued, "We greatly appreciate the dedication and
significant contributions of the employees affected by this decision,
particularly those who were with Maxim during the initial development of
Ceplene."
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and pain.
The Company's broad portfolio of pharmaceutical product candidates
includes Ceplene®, a cytokine immunomodulator that recently
received marketing authorization in Europe for the remission maintenance
of AML patients, and several pain therapies in clinical development. In
addition, EpiCept's ASAP technology, a proprietary live cell
high-throughput caspase-3 screening technology, can efficiently identify
new cancer drug candidates and molecular targets that selectively induce
apoptosis in cancer cells. Two oncology drug candidates currently in
clinical development that were discovered using this technology have
also been shown to act as vascular disruption agents in a variety of
solid tumors.
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 EpiCept's 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 we may not realize our
anticipated cost savings, the risks associated with the adequacy of our
existing cash resources, our need to raise additional financing to
continue to meet our capital needs 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 or that we may
default on our loans or that our lenders may declare the Company in
default or that our secured lender would seek to sell our assets, the
risk that the Company's securities may be delisted by The Nasdaq Capital
Market or the OMX Nordic Exchange and that any appeal of the delisting
determination may not be successful, the risk that Ceplene®
will not receive regulatory approval or marketing authorization in the
U.S. or Canada, the risk that Ceplene® will not be launched
in Europe in the first 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 will not
be successful, the risk that EpiCept will not be able to maintain its
final regulatory approval or marketing authorization, 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 NP-1, including our current clinical
trial in PHN, or EPC-2407 will not be successful, the risk that NP-1 or
EPC-2407 will not receive regulatory approval or achieve significant
commercial success, 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 other product candidates, the risks associated with our
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 EpiCept's periodic reports, including its 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 EpiCept's 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.