EpiCept’s AmiKet™ Receives Fast Track Designation from FDA

  EpiCept’s AmiKet™ Receives Fast Track Designation from FDA

Business Wire

TARRYTOWN, N.Y. -- April 10, 2012

RegulatoryNews:

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced
today that AmiKet™ (amitriptyline 4%, ketamine 2% cream) has been granted Fast
Track designation by the U.S. Food and Drug Administration (FDA). AmiKet™ is
the Company’s late-stage product for the treatment of neuropathic pain
associated with chemotherapy-induced peripheral neuropathy (CIPN) in patients
previously treated with taxane-based chemotherapy.

The FDA's Fast Track program is designed to facilitate the development and
expedite the review of drugs intended to treat serious or life-threatening
conditions and address unmet medical needs. According to the FDA, products
with a Fast Track designation oftentimes receive priority review, which may
reduce the standard review time by half. The Fast Track designation also
allows for more frequent interactions with the FDA during the drug development
process.

“We believe the FDA Fast Track designation is confirmation of the pressing
need for therapies to treat neuropathic pain associated with CIPN,” said Jack
Talley, President and Chief Executive Officer of EpiCept. “We expect the
receipt of this designation will prove to be highly valuable in our current
partnering efforts for AmiKet™.”

EpiCept previously announced the engagement of SunTrust Robinson Humphrey to
assist in exploring strategic alternatives to maximize the commercial
opportunity of AmiKet™. The engagement will focus on the identification and
implementation of a strategy to optimize AmiKet's value for the Company's
stockholders.

About AmiKet™

AmiKet™ is a prescription, topical analgesic cream containing amitriptyline 4%
and ketamine 2% designed to provide relief from neuropathic pain, which
affects more than 15 million people in the U.S. alone. In the first half of
2011, EpiCept announced positive results from a National Cancer
Institute-sponsored study evaluating the efficacy and safety of AmiKet™ in
chemotherapy-induced peripheral neuropathy (CIPN), a painful condition that
frequently occurs following systemic chemotherapy and that may interrupt,
delay or even prevent completion of potentially curative chemotherapy
regimens. A safe and effective therapeutic option for neuropathic pain
associated with CIPN would address a significant unmet medical need.

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 lead oncology 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 other 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.

In January 2012, EpiCept engaged SunTrust Robinson Humphrey to assist the
Company in exploring strategic alternatives to maximize the commercial
opportunity of AmiKet™ for the treatment of 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.

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 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 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 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 Myrexis, the risk that clinical trials for AmiKet™ or
crolibulin^TM will not be successful, the risk that AmiKet™ or crolibulin^TM
will not receive regulatory approval or achieve significant commercial
success, the risk that the development of our EP1013 product candidate will
not be successful, 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 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 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.

EPCT-GEN

                                    # # #

Contact:

EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
LHA
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
@LHA_IR_PR
 
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