EpiCept Files for AmiKet™ Fast Track Designation

EpiCept Files for AmiKet™ Fast Track Designation

 

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 filed for Fast Track designation for AmiKet™
(amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced
peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration (FDA).
AmiKet™ is a prescription topical cream under late stage clinical development by
EpiCept for the treatment of peripheral neuropathic pain.

Jack Talley, EpiCept President and CEO, commented, "Fast Track designation would
significantly accelerate the regulatory development of AmiKet™, and given the
encouragement we received from the FDA and their recognition that the pain
associated with CIPN represents a significant unmet medical need, we are
optimistic that this designation will be granted. In addition, a Fast Track
designation is likely to bolster our ongoing efforts to identify strategic
partners to conduct pivotal clinical and regulatory work necessary for eventual
approval and commercialization in the U.S. and the EU,” Mr. Talley concluded.

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.

On January 23, 2012, EpiCept announced receipt of finalized guidance from the
FDA for the Phase III clinical and nonclinical development and subsequent New
Drug Application (NDA) filing of AmiKet™. As part of this guidance the FDA
waived several expensive and time-consuming non-clinical toxicology studies, and
indicated that a single, four-arm factorial trial might suffice for regulatory
approval if combined with other pivotal data in another neuropathy such as
diabetic peripheral neuropathy. The key element of the proposed Phase III
clinical program is a 12-week, four-arm, factorial-designed trial in CIPN that
would seek to demonstrate AmiKet's superiority compared with placebo and with
each of the component drugs of AmiKet™, amitriptyline and ketamine.

EpiCept intends to submit the protocol for this trial to the FDA via a Special
Protocol Assessment (SPA). An additional two-arm efficacy study in another
painful peripheral neuropathy may be performed as an alternative strategy to a
second factorial-designed trial for the NDA filing, which could potentially lead
to a broader label for AmiKet™ in the treatment of peripheral neuropathic pain.
In addition to the positive outcome previously reported for AmiKet™ in CIPN,
EpiCept has reported statistically significant positive results in the treatment
of pain from post-herpetic neuralgia in several Phase II studies, the
non-inferiority of AmiKet™ compared with gabapentin in another
placebo-controlled study, and a positive trend in the treatment of pain in a
diabetic neuropathy Phase II study.

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
shareholders.

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 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; 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.
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S&anchor=www.sec.gov&index=1&md5=150ad067fbaa4da00955814097895be2) 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
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%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
0159288&lan=en-US&anchor=www.epicept.com&index=2&md5=fcf563d202c5e47b7e861514530
94f15). 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
@LHA_IR_PR