EpiCept Corporation Receives FDA Permission to Initiate AmiKet™ Phase III Clinical Development

EpiCept Corporation Receives FDA Permission to Initiate AmiKet™ Phase III
Clinical Development

 

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

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today
announced that at a meeting earlier this week with the U.S. Food and Drug
Administration (FDA), the Company was granted permission to initiate immediately
the Phase III clinical development of AmiKet™. AmiKet™ (4% amitriptyline, 2%
ketamine) is a prescription topical cream intended for the treatment of
chemotherapy-induced peripheral neuropathy (CIPN) following taxane-based
therapy.

Jack Talley, EpiCept President and CEO, commented, “The guidance we received
from the FDA during our End of Phase II meeting will permit a quick initiation
of AmiKet’s remaining clinical development required for a new drug application
(NDA). Every year, millions of cancer survivors suffer from the effects of their
chemotherapy, and no treatment is yet approved to treat CIPN. AmiKet™ represents
a potentially significant benefit to patients suffering from this painful
indication, and may address an unmet medical need that is well recognized.”

The FDA indicated that a CIPN treatment protocol submitted by the Company will
be reviewed expeditiously for a Special Protocol Assessment (SPA).

The Company has submitted its draft meeting minutes for FDA concurrence and upon
receipt of the FDA official meeting minutes will provide more details regarding
the clinical and non-clinical package required prior to an NDA filing.

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 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 cancer and pain. 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. 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.

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 crolibulinTMwill not be successful, the risk that AmiKet™
or crolibulinTMwill 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; 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=50115748&lan=en-U
S&anchor=www.sec.gov&index=1&md5=2a8e6e4fa071a756bdb66df0aef560f8) 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
0115748&lan=en-US&anchor=www.epicept.com&index=2&md5=cebe04f25d60142fbd1be4aa809
4eff8). 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

Contacts

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