Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today
announced that it has signed an agreement with IDIS, a private,
U.K.-based company, to administer a Named Patient Program for Ceplene®,
EpiCept’s proprietary therapy approved in the European Union for the
remission maintenance and prevention of relapse of patients with Acute
Myeloid Leukemia (AML) in first remission. Under this agreement, Ceplene
is now available on a named patient basis in Europe in advance of its
commercial launch later this year, as well as in the key worldwide
markets including South America, Japan, Australia, Israel and Canada.
"We are excited to partner with a recognized leader in named patient
programs, and to launch patient access to Ceplene in these global
markets,” remarked Jack Talley, President and CEO of EpiCept. "This
agreement provides EpiCept with near-term product revenue and the
opportunity for physician engagement and education on the proper use and
administration of the drug while we continue our thorough selection
process for a commercial partner for Ceplene in Europe. Importantly, the
agreement will provide AML patients in these markets with access to the
first therapy demonstrated to prevent relapse in this devastating
disease.”
A named patient program is a compassionate use drug supply program
through which physicians can prescribe patients with investigational or
approved drugs prior to their commercial launch through a legal and
ethical channel. Under the terms of the agreement, IDIS will be the
exclusive worldwide supplier of the named patient program administration
of Ceplene. Under this program Ceplene will be available in all major
markets worldwide except the United States.
In support of the Named Patient Program for Ceplene, EpiCept will have a
full scientific, medical and commercial presence at the 14th
Annual Meeting of the European Hematology Association, to be held June
4-7, 2009 in Berlin, Germany.
About Ceplene®
Ceplene®
is EpiCept's proprietary product
approved in the European Union for maintenance therapy for adult
patients with AML in first remission. 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. In October 2008, Ceplene
®received
full marketing approval in the European Union for maintenance therapy
and prevention of relapse in adult patients with AML in first remission.
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.
About IDIS
IDIS is the world leader in the development and implementation of Named
Patient Programs and has a proven track record of working in strategic
partnership with U.S.-based companies to bring new medicines to Europe
for the first time. IDIS supports its customers in over 100 countries
worldwide, supplying more than 400 different medicines per month and
responding to more than half a million requests on a named-patient basis
to medical professionals worldwide. Headquartered near central London,
IDIS has been a strategic partner to more than 40 pharmaceutical and
biotech companies. For more information on IDIS, please visit the
website www.idispharma.com
or contact John Lagus at NPP@idispharma.com.
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 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 risk that we will not have
sufficient authorized shares of stock to raise equity capital, 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 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
United States or Canada, 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 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.