TARRYTOWN, N.Y., Oct 26, 2009 (BUSINESS WIRE) — Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene(R) (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(R) to determine the incremental cost effectiveness of Ceplene(R) 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 percent of the population of the European Union. According to the researchers, the expected cost to the U.K. healthcare system to administer Ceplene(R) to all eligible AML patients is approximately GBP24.1 million per year. The estimated annual savings due to decreased relapse events ranges from GBP2.5 to GBP3.5 million. As such, the study concluded that the budget impact to adopt the use of Ceplene(R) 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.” About Ceplene Ceplene(R) is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission. EpiCept is continuing negotiations with several prospective partners for the European marketing rights to Ceplene(R). In June 2009 EpiCept launched a named patient program for Ceplene(R) in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene. 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(TM) 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. EPCT-GEN *Azixa is a registered trademark of Myriad Genetics, Inc.
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(R) to determine the incremental cost effectiveness of Ceplene(R) 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 percent of the population of the European Union. According to the researchers, the expected cost to the U.K. healthcare system to administer Ceplene(R) to all eligible AML patients is approximately GBP24.1 million per year. The estimated annual savings due to decreased relapse events ranges from GBP2.5 to GBP3.5 million. As such, the study concluded that the budget impact to adopt the use of Ceplene(R) 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.” About Ceplene Ceplene(R) is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission. EpiCept is continuing negotiations with several prospective partners for the European marketing rights to Ceplene(R). In June 2009 EpiCept launched a named patient program for Ceplene(R) in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene. 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(TM) 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. EPCT-GEN *Azixa is a registered trademark of Myriad Genetics, Inc.