CepleneTreatment for Acute Myeloid Leukemia
NDA for Ceplene Expected Second Half 2009
EpiCept Receives Permission to File Ceplene NDA
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Feb 2, 2009 - Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the U.S. Food and Drug Administration (FDA) indicated that the Company has the necessary pivotal data to file a New Drug Application (NDA) for Ceplene (histamine dihydrochloride) in conjunction with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia (AML). At a pre-NDA meeting held last week, the FDA provided guidance that it would accept the clinical data along with other analyses, some of which had been submitted as part of the Ceplene Marketing Authorization Application (MAA), which was approved in Europe in October 2008.
At the pre-NDA meeting, the FDA requested that EpiCept provide additional information to the submission package. The requested information includes statistical data further supporting the incremental effectiveness of Ceplene given in conjunction with low-dose IL-2 and data showing the lack of significant efficacy of IL-2 as a monotherapy for remission maintenance of AML. The FDA also requested data supporting Leukemia-Free Survival (LFS) as an appropriate endpoint in the pivotal Phase III study for Ceplene, as compared with Overall Survival. Much of the requested data already has been generated in connection with the European MAA filing.
"We are pleased with the outcome of the pre-NDA meeting. We will be turning our immediate attention to assessing the requirements to submit the NDA in the shortest timeframe possible so as to not deny this unique therapy to AML patients. We are targeting filing the NDA in the second half of this year," stated Jack Talley, President and Chief Executive Officer of EpiCept. "This is an important advance of our commercial strategy. Ceplene is the first and only approved immunotherapy shown to significantly prolong LFS and prevent relapse among AML patients in first remission. We continue to make progress with our partner selection process for Ceplene in Europe, where the drug has full marketing approval, and we will continue to diligently pursue regulatory approval for this important therapy in North America. Our intent remains steadfast that with the approval of Ceplene in North America, we will build a fully integrated commercial organization centered around hematology to market Ceplene and complementary products."
In December 2008, EpiCept announced that it had received permission from Health Canada to proceed with a New Drug Submission (NDS) filing for Ceplene for the treatment of AML. The NDS filing is expected to occur prior to the NDA filing. Decisions by regulators on both applications are expected in 2010.
Ceplene is EpiCept's proprietary product approved in the European Union for maintenance therapy for adult patients with AML in first remission. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells. In October 2008, Ceplene received full marketing approval in the European Union for maintenance therapy and prevention of relapse in adult patients with AML in first remission.
About Acute Myeloid Leukemia (AML)
AML is the most common type of leukemia in adults. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70-80% of patients who achieve first remission will relapse, with the median time in remission before relapse being only 12 months. Less than 15% of relapsed patients survive long-term.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and pain. The Company's broad portfolio of pharmaceutical product candidates includes Ceplene, a cytokine immunomodulator that recently received marketing authorization in Europe for the remission maintenance of AML patients, and several pain therapies in clinical development. Two oncology drug candidates currently in clinical development that were discovered using in-house technology have also been shown to act as vascular disruption agents in a variety of solid tumors.
This news release and any oral statements made with respect to the information contained in this news release, contains 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 EpiCept's 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 U.S. or Canada, the risk that Ceplene will not be launched in Europe in the first half of 2009 or achieve significant commercial success, the risk that we are unable to find a suitable marketing partner for Ceplene on attractive terms, a timely basis or at all, the risk that any required post-approval clinical study will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization, the risk that we may not realize our anticipated cost savings, the risks associated with the adequacy of our existing cash resources, our need to raise additional financing to continue to meet our capital needs 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 or that we may default on our loans or that our lenders may declare us in default or that our secured lender would seek to sell our assets, the risk that our securities may be delisted by The Nasdaq Capital Market or the OMX Nordic Exchange and that any appeal of the delisting determination may not be successful, the risk that Myriad's development of Azixa™ will not be successful, 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 we will not be able to find a buyer for our ASAP technology, the risk that clinical trials for NP-1, including our current clinical trial in PHN, or EPC-2407 will not be successful, the risk that NP-1 or EPC-2407 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 other product candidates, the risks associated with our 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 EpiCept's 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: February 2009
- EpiCept Corporation Receives Refusal to File Letter from US FDA on Ceplene New Drug Application - August 23, 2010
- EpiCept Files New Drug Application for Ceplene in AML - June 29, 2010