EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced that the Israeli Ministry of Health has approved the marketing application for Ceplene®, indicated for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Megapharm Ltd. is EpiCept's partner in Israel and upon Ministry of Health approval of labeling and other technical matters the company is expected to launch Ceplene® in the first quarter of 2011.
EpiCept also anticipates that new marketing applications for Ceplene® will be filed in several non-EU European and Pacific Rim countries in early 2011 by its marketing partner Meda AB.
Jack Talley, EpiCept President and CEO commented: "We are delighted that with this approval doctors in Israel will be able to prescribe Ceplene® for their patients who are in first AML remission. Some of these doctors have worked with us for many years to help obtain marketing approval in the European Union, so we are especially gratified that their efforts will allow them to use Ceplene® in their own medical practices. We also look forward to further expanding the number of countries in which Ceplene® is available through the new marketing applications expected to be filed by Meda next year."
About Ceplene
Ceplene® is approved in the European Union and is indicated for remission maintenance therapy and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML), one of four types of leukemia. Ceplene® is used together with low dose Interleukin-2. The prevalence for AML in the EU is about 41,000 patients and over 16,000 new cases are diagnosed every year. While current induction and consolidation treatments are successful in inducing complete remission for the majority of AML patients, this remission is generally short-lived. After achieving complete remission most patients will suffer a relapse within one year. In an international, multicenter, open-label, randomized Phase III study, Ceplene® met its primary endpoint of prolonging leukemia-free survival for AML patients in remission. The difference between the treated and control group was highly statistically significant (p