Clear Regulatory Pathway of Amiket Identified
On January 24, 2012, EpiCept Corporation (OTC: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 (NYSE: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 (NYSE:MAA) for the European Union.
New Strategy May Maximize AmiKet™ Potential
On January 9, EpiCept (OTC: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.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.