Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that the European Commission has granted a full marketing
authorization in the form of a positive Commission Decision, for Ceplene®
(histamine dihydrochloride) for the remission maintenance and prevention
of relapse in adult patients with Acute Myeloid Leukemia (AML) in first
remission. Ceplene is to be administered in conjunction with low-dose
interleukin-2 (IL-2). The approval allows Ceplene to be marketed in the
27 member states of the European Union (EU), as well as in Iceland,
Liechtenstein and Norway.
"Today marks a significant and welcome
milestone for patients suffering from AML,”
stated Jack Talley, president and CEO of EpiCept. "Ceplene
is now the first approved therapy demonstrated to produce a clear
benefit in prolonging leukemia-free survival and preventing relapse
among AML patients. We are proud that this new therapeutic option will
be available to physicians and patients in 30 countries.”
The approval by the European Commission is based, in part, on the
results of the pivotal 320-patient Phase III trial for Ceplene in
conjunction with IL-2. The primary result of this trial was that
treatment with Ceplene/IL-2 significantly reduced the occurrence of
relapse among AML patients in complete remission. The improvement of
long-term leukemia-free survival in patients receiving Ceplene/IL-2
exceeded 50%. Moreover, Ceplene was well tolerated in this patient
population and conferred an acceptable risk benefit profile for AML
patients.
"The main challenge in AML treatment is to
protect patients in their first complete remission from relapse, as a
first relapse is associated with poor long-term survival. The
combination of Ceplene and IL-2 has been demonstrated to be a safe
therapy that improves leukemia-free survival by significantly reducing
the risk of recurrent leukemia. Therefore, the approval granted for
Ceplene is an important step forward in making the treatment available
to AML patients,” said Mats Brune, M.D.,
associate professor at Sahlgrenska University and principal investigator
of the Ceplene Phase III clinical trial.
"Ceplene improves the capacity of the patients’
immune cells to attack and destroy malignant cells,”
said Kristoffer Hellstrand, M.D., Ph.D., professor at the University of
Gothenburg, Sweden and the discoverer of the Ceplene technology. "Ceplene/IL-2
therapy is intended to eliminate residual AML cells, which are the cause
of relapse in AML patients.”
As a result of its designation as an Orphan Medical Product, EpiCept has
been granted 10 years of market exclusivity in the EU for Ceplene. As
part of receiving marketing authorization under Exceptional
Circumstances for Ceplene, EpiCept will perform two post-approval
clinical studies. One of the studies will seek to further elucidate the
clinical pharmacology of Ceplene by assessing certain biomarkers in AML
patients in first remission. The other study will assess the effect of
Ceplene/IL-2 on the development of minimal residual disease in the same
patient population. EpiCept is considering combining these studies into
a single clinical trial.
Mr. Talley continued: "Several potential
commercial partners with established sales infrastructures in hematology
and oncology in Europe have expressed interest in marketing Ceplene and
are in various stages of due diligence. We expect to share further
details on our commercialization strategy later this year.”
EpiCept has also advanced its efforts to gain approval for Ceplene as a
remission maintenance treatment for AML patients in North America. A
pre-New Drug Submission meeting with Health Canada has been scheduled
during the fourth quarter of 2008, and will be followed in the first
quarter of 2009 by a pre-New Drug Application meeting with the United
States Food and Drug Administration.
About Ceplene
Ceplene is EpiCept's proprietary product approved for the treatment of
AML. Ceplene is designed to protect lymphocytes responsible for
immune-mediated destruction of residual leukemic cells. Laboratory
research has demonstrated that Ceplene reduces formation of oxygen
radicals from phagocytes, inhibiting NADPH oxidase and protecting
IL-2-activated NK-cells and T-cells.
About Acute Myeloid Leukemia (AML)
AML is the most common type of leukemia in adults. There are
approximately 40,000 AML patients in the EU, with 16,000 new cases
occurring each year. Once diagnosed with AML, patients typically receive
induction and consolidation chemotherapy, with the majority achieving
complete remission. However, about 70-80% of patients who achieve first
remission will relapse, with the median time in remission before relapse
being only 12 months. Less than 15% of relapsed patients survive
long-term.
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 Ceplene will not be launched in
Europe in the first quarter 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 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 our ASAP technology will not yield any
successful product candidates, the risk that clinical trials for NP-1 or
EPC2407 will not be successful, the risk that NP-1 or EPC2407 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 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, the risk that we will not obtain
approval to market any of our product candidates other than Ceplene®,
the risk that the Company’s securities may be
delisted by The Nasdaq Capital Market or the OMX Nordic Exchange, 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; risks
associated with prior material weaknesses in our internal controls; 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.