EpiCept CorporationEpiCept Corporation announced that the US 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 leukaemia (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 Leukaemia-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 centred around haematology 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 leukaemic 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.

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.