TARRYTOWN, N.Y. - (Business Wire) Regulatory News: 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.”
About Ceplene®
Ceplene® 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®. In June 2009 EpiCept launched a named patient program for Ceplene® 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™ 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.
Forward-Looking Statements
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 our 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 United States or Canada, the risk that Ceplene® will not be launched 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 for Ceplene® will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®, the risks associated with the adequacy of our existing cash resources 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, the risk that our securities may be delisted by The Nasdaq Capital Market 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 EpiCeptTM NP-1 or crinobulin will not be successful, the risk that EpiCept™ NP-1 or crinobulin will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept™ NP-1 on attractive terms, a timely basis or at all, 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 product candidates, the risks associated with 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 our 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.
EPCT-GEN
*Azixa is a registered trademark of Myriad Genetics, Inc.
EpiCept Corporation:
Robert W. Cook, 914-606-3500
mail@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
