New findings demonstrating pharmacoeconomic benefits of Ceplene released

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene® (histamine dihydrochloride) for the remission maintenance of Acute Myeloid Leukemia (AML) patients in first remission. These data are being presented in two separate poster presentations on October 25 and 27, 2009 in Paris, France at the Twelfth Annual European Congress of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).

Researchers from Applied Healthcare Resource Management Inc. engaged by EpiCept analyzed data from the pivotal Phase III clinical trial for Ceplene® to determine the incremental cost effectiveness of Ceplene® with low-dose interleukin-2 (IL-2) versus current standard of care for remission maintenance of AML patients in first complete remission. The focus of the researchers was on the economic impact on the healthcare system in the United Kingdom. The United Kingdom represents approximately 13% of the population of the European Union.

According to the researchers, the expected cost to the U.K. healthcare system to administer Ceplene® to all eligible AML patients is approximately £24.1 million per year. The estimated annual savings due to decreased relapse events ranges from £2.5 to £3.5 million. As such, the study concluded that the budget impact to adopt the use of Ceplene® plus low-dose IL-2 for AML is well within the established per-patient reimbursement threshold for a new drug. The analysis assumes that all eligible patients are treated; if fewer patients are treated, then the net budget impact would be less.

The pharmacoeconomic benefit of Ceplene® may have been underestimated in this model, as a monetary value was not assigned to the quality of life improvement that is associated with fewer relapses.

“As the only therapy approved in Europe to maintain first remission in AML patients, we believe Ceplene® can play a unique role in addressing this deadly disease,” remarked Jack Talley, President and CEO of EpiCept. “We commissioned this study to further validate the commercial potential of Ceplene® to prospective partners, and guide the pricing and reimbursement rationale for this innovative medicine.”


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