Healthcare Industry News: Ceplene
News Release - September 18, 2007
EpiCept Reports Regulatory Progress on Ceplene(TM)Application for AML Remission Maintenance Therapy
Advances on Schedule Following Meeting with EMEA
TARRYTOWN, N.Y., Sept. 18 (HSMN NewsFeed) -- EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today reported that the assessment of its European Union centralized marketing authorization application for its lead oncology product Ceplene(TM) is advancing according to the anticipated regulatory timetable following a meeting yesterday. Ceplene (histamine dihydrochloride) has demonstrated important clinical benefit in the maintenance of remission for patients with Acute Myeloid Leukemia (AML).
EpiCept's Marketing Authorization Application (MAA) for Ceplene has reached the next important step in its assessment by the Committee for Human Medicinal Products (CHMP). Specifically, EpiCept submitted full responses to the Day 120 Consolidated List of Questions. EpiCept's staff and expert consultants met on September 17 with EMEA officials and CHMP representatives to discuss these responses. Included with the Day 120 response documentation, EpiCept has provided data on Ceplene's effect on quality of life and on long term follow up of at least five years on leukemia-free survival for AML patients.
"We are pleased to have reached the latest regulatory milestone for Ceplene in the EU, and to be closer to our goal of providing hematologists with the first remission maintenance immunotherapy for AML patients," stated Jack Talley, President and Chief Executive Officer of EpiCept. "EpiCept outlined to the EMEA and CHMP representatives how the data package for Ceplene supports approval. We look forward to working with the regulators to complete their assessment. We are enthusiastic about the potential of Ceplene, which in our pivotal trial increased the long-term, disease-free survival of AML patients by more than 50%. Importantly, this significant therapeutic benefit was achieved with a remarkably well-tolerated, self-administered immunotherapy."
EpiCept's MAA submission for Ceplene is being assessed under the EU centralized procedure, and if approved, will provide a marketing authorization valid in all EU member states, along with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML. If the application for Ceplene continues to follow usual EU regulatory timelines, the next milestone on Ceplene's path to approval is expected to be the CHMP Day 180 list of outstanding issues, which EpiCept expects will be received in the fourth quarter of 2007. EpiCept expects this to be followed by a recommendation regarding approvability from the CHMP and a final decision by the European Commission during the first half of 2008.
Ceplene is EpiCept's registration-stage compound for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic 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.
About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults. There are approximately 47,000 AML patients in the EU, with 14,000 new cases occurring each year. For the majority of AML patients, the prospects for long-term survival are disappointing. Once diagnosed with AML, patients are treated with toxic chemotherapies. Although approximately 75% of patients achieve a complete remission, the leukemia frequently recurs (a "relapse"), usually within 1-2 years. Despite follow-up treatment that may include very toxic chemotherapy or bone marrow transplantation, only 10% to 20% of patients survive long term after relapse. There are currently no proven treatments for maintaining long-term remission for AML patients.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of pain and cancer. EpiCept has a staged portfolio of pharmaceutical product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, or AML) with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound has been submitted in Europe. EpiCept is based in Tarrytown, N.Y., and its research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
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 EpiCept's 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 EU or that Ceplene, if approved, will not achieve significant commercial success, the risk that Myriad's development of Azixa(TM)* 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 our ASAP technology will not yield any successful product candidates, the risk that clinical trials for NP-1 will not be successful, that NP-1 will not receive regulatory approval or achieve significant commercial success, 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 EpiCept will not obtain approval to market any of its product candidates, the risks associated with reliance on additional outside financing to meet its capital requirements, 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; competition; litigation; risks associated with prior material weaknesses in our internal controls; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in EpiCept's periodic reports, including its 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 EpiCept's 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.
*Azixa is a registered trademark of Myriad Genetics, Inc.
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