EbpiCept Corporation
(Nasdaq and OMX Nordic Exchange: EPCT) reported that the assessment
of its European Union centralized marketing authorization application for
its lead oncology product Ceplene(TM) is advancing according to the
anticipated regulatory timetable following a meeting yesterday. Ceplene
(histamine dihydrochloride) has demonstrated important clinical benefit in
the maintenance of remission for patients with Acute Myeloid Leukemia
(AML).
EpiCept's Marketing Authorization Application (MAA) for Ceplene has
reached the next important step in its assessment by the Committee for
Human Medicinal Products (CHMP). Specifically, EpiCept submitted full
responses to the Day 120 Consolidated List of Questions. EpiCept's staff
and expert consultants met on September 17 with EMEA officials and CHMP
representatives to discuss these responses. Included with the Day 120
response documentation, EpiCept has provided data on Ceplene's effect on
quality of life and on long term follow up of at least five years on
leukemia-free survival for AML patients.
"We are pleased to have reached the latest regulatory milestone for
Ceplene in the EU, and to be closer to our goal of providing hematologists
with the first remission maintenance immunotherapy for AML patients,"
stated Jack Talley, President and Chief Executive Officer of EpiCept.
"EpiCept outlined to the EMEA and CHMP representatives how the data package
for Ceplene supports approval. We look forward to working with the
regulators to complete their assessment. We are enthusiastic about the
potential of Ceplene, which in our pivotal trial increased the long-term,
disease-free survival of AML patients by more than 50%. Importantly, this
significant therapeutic benefit was achieved with a remarkably
well-tolerated, self-administered immunotherapy."
EpiCept's MAA submission for Ceplene is being assessed under the EU
centralized procedure, and if approved, will provide a marketing
authorization valid in all EU member states, along with Iceland,
Liechtenstein and Norway. The European Commission has previously granted
orphan drug status to Ceplene for use in the treatment of AML. If the
application for Ceplene continues to follow usual EU regulatory timelines,
the next milestone on Ceplene's path to approval is expected to be the CHMP
Day 180 list of outstanding issues, which EpiCept expects will be received
in the fourth quarter of 2007. EpiCept expects this to be followed by a
recommendation regarding approvability from the CHMP and a final decision
by the European Commission during the first half of 2008.
About Ceplene
Ceplene is EpiCept's registration-stage compound 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 form of acute leukemia in adults. There are
approximately 47,000 AML patients in the EU, with 14,000 new cases
occurring each year. For the majority of AML patients, the prospects for
long-term survival are disappointing. Once diagnosed with AML, patients are
treated with toxic chemotherapies. Although approximately 75% of patients
achieve a complete remission, the leukemia frequently recurs (a "relapse"),
usually within 1-2 years. Despite follow-up treatment that may include very
toxic chemotherapy or bone marrow transplantation, only 10% to 20% of
patients survive long term after relapse. There are currently no proven
treatments for maintaining long-term remission for AML patients.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer.
EpiCept has a staged portfolio of pharmaceutical product candidates with
several pain therapies in late-stage clinical trials, and a lead oncology
compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in
a Phase III trial; a marketing authorization application for this compound
has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its
research and development team in San Diego is pursuing a drug discovery
program focused on novel approaches to apoptosis.
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 receive regulatory approval or marketing
authorization in the EU or that Ceplene, if approved, will not achieve
significant commercial success, the risk that Myriad's development of
Azixa(TM)* 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 will not be successful, that NP-1 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 EpiCept will not obtain approval to
market any of its product candidates, the risks associated with reliance on
additional outside financing to meet its capital requirements, 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; competition; 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 sec or at epicept.
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.
Azixa is a registered trademark of Myriad Genetics, Inc.
EpiCept Corporation
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