EpiCept Corporation Engages SunTrust Robinson Humphrey to Advise on Strategy to Maximize AmiKet™ Potential

EpiCept Corporation Engages SunTrust Robinson Humphrey to Advise on Strategy to
Maximize AmiKet™ Potential

 

TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))-- Regulatory
News:

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today
announced that it has engaged SunTrust Robinson Humphrey to assist in exploring
strategic alternatives to maximize the commercial opportunity of AmiKet™, the
Company’s prescription topical cream intended for the treatment of
chemotherapy-induced peripheral neuropathy (CIPN) following taxane-based
therapy. The engagement will focus on the identification and implementation of a
strategy designed to optimize AmiKet’s value for the Company’s shareholders.

Jack Talley, EpiCept’s President and CEO, stated, “EpiCept is committed to
optimizing the value of our assets. We are initiating a formal process with
SunTrust Robinson Humphrey to assist us in this effort, and specifically to
maximize the value of AmiKet™. We believe that the engagement will result in a
greater level of market appreciation for the consistently positive clinical
results we have achieved in a variety of neuropathic pain indications including
recent positive data in CIPN, the significant market potential we have
identified in an indication that is woefully underserved, and the recent
favorable End-of-Phase II meeting with the FDA. A successful outcome of this
engagement will enable the product to move forward quickly through its final
stage of clinical and regulatory development and we have instructed SunTrust
Robinson Humphrey to explore all possible avenues to help us achieve this goal.”

In December 2011, EpiCept announced that at a recent meeting with the U.S. Food
and Drug Administration (FDA) the Company was given permission to commence Phase
III clinical development of AmiKet™ for the treatment of CIPN, and that a
Special Protocol Assessment (SPA) would be available upon formal submission and
agreement as to the Phase III trial protocol.

During the fourth quarter of 2011, a U.S. market evaluation of the CIPN
opportunity was completed by an independent market assessment firm engaged by
EpiCept. Among the study’s conclusions was that peak annual revenue for AmiKet™
treating CIPN in the U.S. alone could exceed $400 million through a specialty
pharmaceutical sales force of less than 150 targeting the top six deciles of
prescribing oncologists, pain specialists and neurologists. The study determined
that the number of cases of malignant cancer diagnoses of breast, prostate, lung
and ovarian cancers currently exceeds 3.5 million, and estimated that 90% of all
prostate and ovarian cancer patients, 75% of all breast cancer patients and more
than 60% of all lung cancer patients are treated with taxanes, either alone or
in combination with other chemotherapeutic drugs. Based on physician interviews,
expert opinions and a review of the medical literature, the study concluded that
a significant percentage of this group develops some form of CIPN.

About AmiKet™

AmiKet™ is a prescription, topical analgesic cream containing 4% amitriptyline
and 2% ketamine 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 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 cancer and pain. 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.

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 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 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 we will not receive any significant payments
under our agreement with Myrexis, the risk that the development of our other
apoptosis product candidates will not be successful, 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 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; the risk that our securities may be delisted from
Nasdaq OMX Stockholm; 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fus.
lrd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3oDMTEzM2pvaWgxBHB
vcwMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15t064n6f%2F**http%253A%2F
cts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%25252F%2
5252Fwww.sec.gov%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dwww.sec.gov%2
526index%3D2%2526md5%3D61ec7b72044301e411e3335754ee5c07&esheet=50126055&lan=en-U
S&anchor=www.sec.gov&index=1&md5=b8c94f84aeef094903fe1f8ee3c5c412) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2
Fus.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3DX3oDMTE2OGhhcWs
4BHBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2FSIG%3D1659oglun%2F**http
%253A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%
25252F%25252Fwww.epicept.com%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dw
ww.epicept.com%2526index%3D3%2526md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=5
0126055&lan=en-US&anchor=www.epicept.com&index=2&md5=04692175dacc3c04e0ae8bfd6f1
e5039). 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

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