CepleneTreatment for Acute Myeloid Leukemia
NDA Submitted for Ceplene
EpiCept Files New Drug Application for Ceplene in AML
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Jun 29, 2010 - EpiCept Corporation announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission. Ceplene was approved for this indication by the European Commission in October 2008 and is currently available in the United Kingdom, Germany and Austria. Ceplene is expected to be available throughout most of the European Union within twelve months.
In its application, EpiCept requested priority review of the NDA. If granted, priority review should result in an FDA decision date in late December 2010. A decision with respect to the granting of priority review must be made within 45 days of the filing date. Ceplene has been granted orphan drug status in the United States, providing seven years' marketing exclusivity from the NDA approval date.
"This filing is a very important milestone in our strategy for Ceplene, and we are delighted to submit the NDA consistent with the timetable we publicly announced," stated Jack Talley, President and Chief Executive Officer of EpiCept. "There are an estimated 9,000 deaths caused by AML each year in the U.S. with no effective maintenance therapy currently available. We believe that Ceplene, if approved, would favorably impact the prognosis of patients with this lethal disease."
The NDA submission is supported by a robust body of evidence demonstrating a significant clinical benefit of Ceplene/IL-2 for remission maintenance in AML as compared with the standard-of-care, which is no treatment. The pivotal Phase III study was conducted in ten countries and included 320 randomized patients. The data demonstrated that patients with AML in complete remission who received up to 18 months of treatment with Ceplene plus low-dose IL-2 experienced a significantly longer period of leukemia-free survival (LFS) compared to the standard-of-care. The difference between the treated and control group was statistically significant (p<0.008). Ceplene is the only medical therapy shown to extend LFS in this deadly form of leukemia.
At the request of the FDA, EpiCept has included in its NDA the results of two meta-analyses to help isolate Ceplene's efficacy. The first analysis confirmed the lack of clinical efficacy of IL-2 monotherapy as remission maintenance for AML patients and the second demonstrated the contribution of Ceplene in this indication when given in conjunction with IL-2. These two meta-analyses were conducted by independent statisticians and support the conclusions of the pivotal Phase III trial.
If priority review is not granted, the FDA has up to 60 days to accept the filing for review and assign an FDA decision date. In addition to the NDA filing in the U.S., a New Drug Submission for Ceplene is currently under active review by Health Canada, which is expected to complete its review and provide a decision by the fourth quarter of 2010. Ceplene is also under review by the Israeli Ministry of Health. As noted earlier, Ceplene is approved in thirty countries in Europe.
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, 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 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 EpiCept™ 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.
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 Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that clinical trials for EpiCept NP-1 or crolibulinTM will not be successful, the risk that EpiCept NP-1 or crolibulin 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 NP-1 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 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
Contact: EpiCept Corporation:
Robert W. Cook, 914-606-3500
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100
Posted: June 2010
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