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EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results
Date:11/4/2007

bout the prospects for Ceplene's approval, and the application continues to be reviewed according to the expected timetable. We now await the next regulatory milestone, the CHMP's Day 180 Assessment Report and List of Outstanding Issues, which we expect to receive in late November. We will continue to work closely with the EMEA and the CHMP to address any outstanding issues so that the CHMP will be in a position to render a positive opinion."

EpiCept reported progress with several of its key product candidates during the third quarter and subsequent weeks, including:

Ceplene(TM) - a registration-stage compound for the treatment of Acute Myeloid Leukemia (AML), the most common type of leukemia in adults, currently undergoing regulatory review by the European Medicines Agency for the Evaluation of Medicinal Products (EMEA). During the third quarter EpiCept reported that the Marketing Authorization Application (MAA) for Ceplene is advancing according to the anticipated regulatory timetable. The company submitted its full responses to the Day 120 Consolidated List of Questions to the Committee for Human Medicinal Products (CHMP) and EpiCept's staff and consultants met with EMEA officials and CHMP representatives to discuss these responses on September 17, 2007. EpiCept expects to receive the CHMP's Day 180 Assessment Report and List of Outstanding Issues in late November 2007. The company continues to be optimistic about the prospects for approval for this product in the first half 2008. If the application for Ceplene continues to follow usual E.U. regulatory timelines, the likely regulatory milestone for Ceplene following receipt of the Day 180 List of Outstanding Issues will be the option, if required, for EpiCept to attend a Day 181 Oral Explanation with the CHMP to resolve any outstanding issues.

EpiCept NP-1 - a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies, which affect more tha
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SOURCE EpiCept Corporation
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