Amiket, Another Key Value Driver for EpiCept
Grant Zeng, CFA
Clear Regulatory Pathway of Amiket Identified
On January 24, 2012,
EpiCept Corporation (
EPCT
)
received further encouraging guidance for the Phase III clinical
and nonclinical development and subsequent New Drug Application
(NDA) filing of AmiKet™ in the treatment of chemotherapy- induced
peripheral neuropathy (CIPN) based on the issuance of the final
minutes of the Company's meeting with the FDA in December 2011.
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.
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.
In the final meeting minutes recently received by EpiCept, the FDA
acknowledged that painful symptoms due to CIPN represent a
significant unmet medical need and encouraged EpiCept to apply for
Fast Track designation. Further, 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 in the treatment of
peripheral neuropathic pain.
The meeting minutes included a summary of the nonclinical program
requirements to file an NDA, which notably included only a single
dermal carcinogenicity study. The dermal photo-irritation/toxicity
assessment may be waived, provided dermal photo-irritation is
assessed in the clinical program. A COMET assay (Single Cell Gel
Electrophoresis to detect DNA damage) study is required prior to
initiation of the long-term open label clinical safety study.
We think the minutes from the FDA meeting are very positive. The
FDA's requirements for the clinical and nonclinical programs to
support an AmiKet™ NDA filing are achievable. This is a very
favorable outcome that will likely benefit AmiKet's market
opportunity and time to NDA filing. Further, this will facilitate
SunTrust Robinson Humphrey's efforts to identify potential
acquirers or strategic partners to advance AmiKet™ towards approval
and commercialization in the United States. This program may also
facilitate the filing of a marketing authorization application (
MAA
) for the European Union.
New Strategy May Maximize AmiKet™ Potential
On January 9, EpiCept (
EPCT
) announced that it has engaged 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 designed to
optimize AmiKet's value for the Company's shareholders.
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.
A successful outcome of this engagement will enable the product to
move forward quickly through its final stage of clinical and
regulatory development. This will optimize AmiKet's value for the
Company's shareholders in our view.
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EPCT
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