Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
announced today it has received notice of termination, effective as of
August 28, 2012, of its License and Collaboration Agreement with
Myrexis, Inc. Among the compounds that had been licensed to Myrexis
under the terminated agreement was EpiCept's anti-cancer drug candidate
Azixa®.
Azixa® is a vascular disruption agent discovered by EpiCept
that has demonstrated potent anti-cancer activity. Azixa® has
received orphan drug status in the U.S. for the treatment of
glioblastoma multiforme (GBM).
In February 2012, Myrexis suspended development activities of all its
preclinical and clinical programs in oncology and autoimmune diseases,
and in May 2012 stated that it is focused on the identification,
evaluation and acquisition of appropriate commercial-stage assets.
Accordingly, Myrexis has elected to terminate its efforts to develop and
commercialize any product, including Azixa®, in any major
market as such products and markets are defined in the License and
Collaboration agreement dated November 19, 2003. As a result of the
termination of the agreement, all rights and licenses granted under the
agreement by EpiCept to Myrexis have terminated and reverted to EpiCept.
"We are pleased to regain rights to Azixa® following
suspension of development efforts by Myrexis last September,” remarked
Robert Cook, interim President and CEO of EpiCept. "We will now seek to
exploit Azixa®’s potential with prospective partners.”
Azixa® was the subject of a two-arm Phase 2b trial in
patients newly diagnosed with GBM initiated in December 2010, but not
completed by Myrexis following its decision to suspend development in
September 2011.
EpiCept engaged SunTrust Robinson Humphrey in January 2012 to assist in
exploring strategic alternatives to maximize the commercial opportunity
of AmiKet™ for the treatment of chemotherapy-induced peripheral
neuropathy (CIPN) following taxane-based therapy. The engagement is
focused on the identification and implementation of a strategy designed
to optimize AmiKet™’s value for the Company’s stockholders, which
includes the evaluation of potential transactions involving the sale of
the Company. Azixa® has now been added to the Company’s
portfolio of products available for partnering or other development.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of
pharmaceutical products for the treatment of pain and cancer. The
Company's pain portfolio includes AmiKet™, a prescription topical
analgesic cream in late-stage clinical development designed to provide
effective long-term relief of pain associated with peripheral
neuropathies. The Company's product Ceplene®, when used
concomitantly with low-dose interleukin-2 (IL-2) is intended as
remission maintenance therapy in the treatment of acute myeloid leukemia
(AML) for adult patients who are in their first complete remission. The
Company sold all of its rights to Ceplene® in Europe and
certain Pacific Rim countries and a portion of its remaining Ceplene®
inventory to Meda AB. Ceplene® is licensed to MegaPharm Ltd.
to market and sell in Israel and EpiCept has retained its rights to
Ceplene® in all other countries, including countries in North
and South America. The Company has other oncology drug candidates 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.
Forward-Looking Statements
This news release and any oral statements made with respect to the
information contained in this news release contain 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 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 Azixa®
will not receive regulatory approval or achieve significant commercial
success, the risk that clinical trials for AmiKet™ or crolibulinTM will
not be successful, the risk that AmiKet™ or crolibulinTM 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 AmiKet™ on attractive terms, a timely
basis or at all, the risk that Ceplene® will not receive
regulatory approval or marketing authorization in the United States or
Canada, the risk that Ceplene® will not 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 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.
*Azixa is a registered trademark of Myrexis, Inc.
