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news.The Israeli Ministry of Health has approved EpiCept's marketing application for Ceplene, indicated for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.
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Megapharm 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.
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.
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.
EpiCept president and CEO Jack Talley said that they 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," Talley said.
"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."