EpiCept Receives Orphan Drug Designation for EpiCept(TM) NP-1 in U.S.
TARRYTOWN, N.Y., Jan 27, 2010 (BUSINESS WIRE) -- Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a condition affecting less than 200,000 Americans. The designation offers a number of incentives to the treatment developer, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization. Funding for clinical studies, study design assistance, waiver of FDA user fees and tax credits are additional potential incentives.
"NP-1's orphan drug designation is another indication of the significant need that exists for new and more effective treatment options for patients suffering from PHN," remarked Jack Talley, President and Chief Executive Officer of EpiCept. "Our recent Phase IIb study of NP-1 in the PHN indication demonstrated that it has at least equivalent efficacy to the unit market leader, gabapentin, which we believe is a strong indicator of its future clinical and commercial potential. We believe this orphan drug designation is likely to shorten the time required to file a New Drug Application with the FDA, obtain an approval to treat patients suffering from PHN and thereafter to help patients suffering from other forms of neuropathic pain."
In January 2009, EpiCept reported positive results from a 360-patient Phase IIb trial of NP-1 in patients with PHN. In this trial NP-1 achieved statistically significant pain relief compared with placebo and was equivalent in pain relief to the market leader gabapentin. A trial in chemotherapy-induced peripheral neuropathy (CPN) is currently being conducted in collaboration with the National Cancer Institute (NCI)-funded Community Clinical Oncology Program. The results are anticipated by the end of 2010.
About EpiCept NP-1
EpiCept NP-1 is a prescription topical analgesic cream designed to provide effective, long-term relief from the pain of peripheral neuropathies. Peripheral neuropathies are medical conditions caused by damage to the nerves in the peripheral nervous system. The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. Peripheral neuropathies are associated with conditions that injure peripheral nerves, including herpes zoster, or shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral neuropathies can also be caused by trauma or may result from surgical procedures. EpiCept NP-1 Cream is a patented formulation containing two FDA-approved drugs, amitriptyline (a widely-used antidepressant) and ketamine (an NMDA antagonist that is used as an anesthetic).
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 product is Ceplene(R), 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 in first remission. The Company has two 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 EpiCeptTM NP-1, 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 clinical trials for EpiCeptTM NP-1 will not be successful, the risk that EpiCept(TM) NP-1 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 EpiCept(TM) NP-1 on attractive terms, a timely basis or at all, the risk that Ceplene will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene will not be launched or 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 our securities may be delisted by The Nasdaq Capital Market and that any appeal of the delisting determination may not be successful, the risk that Myriad's development of Azixa(TM) will not be successful, the risk that Azixa(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that we will not be able to find a buyer for our ASAP technology, the risk that clinical trials for crinobulin will not be successful, the risk that crinobulin will not receive regulatory approval or achieve significant commercial success, 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 or at www.epicept.com. 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.