Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announces the
release of new findings demonstrating the pharmacoeconomic benefits of
Ceplene® (histamine dihydrochloride) for the remission
maintenance of Acute Myeloid Leukemia (AML) patients in first remission.
These data are being presented in two separate poster presentations on
October 25 and 27, 2009 in Paris, France at the Twelfth Annual European
Congress of the International Society of Pharmacoeconomics and Outcomes
Research (ISPOR).
Researchers from Applied Healthcare Resource Management Inc. engaged by
EpiCept analyzed data from the pivotal Phase III clinical trial for
Ceplene® to determine the incremental cost effectiveness of
Ceplene® with low-dose interleukin-2 (IL-2) versus current
standard of care for remission maintenance of AML patients in first
complete remission. The focus of the researchers was on the economic
impact on the healthcare system in the United Kingdom. The United
Kingdom represents approximately 13% of the population of the European
Union.
According to the researchers, the expected cost to the U.K. healthcare
system to administer Ceplene® to all eligible AML patients is
approximately £24.1 million per year. The estimated annual savings due
to decreased relapse events ranges from £2.5 to £3.5 million. As such,
the study concluded that the budget impact to adopt the use of Ceplene®
plus low-dose IL-2 for AML is well within the established per-patient
reimbursement threshold for a new drug. The analysis assumes that all
eligible patients are treated; if fewer patients are treated, then the
net budget impact would be less.
The pharmacoeconomic benefit of Ceplene® may have been
underestimated in this model, as a monetary value was not assigned to
the quality of life improvement that is associated with fewer relapses.
"As the only therapy approved in Europe to maintain first remission in
AML patients, we believe Ceplene® can play a unique role in
addressing this deadly disease,” remarked Jack Talley, President and CEO
of EpiCept. "We commissioned this study to further validate the
commercial potential of Ceplene® to prospective partners, and
guide the pricing and reimbursement rationale for this innovative
medicine.”
About Ceplene®
Ceplene® is approved in the European Union for the remission
maintenance and prevention of relapse in patients with AML in first
remission. EpiCept 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
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.