Meda paid $3 million for exclusive rights to leukemia drug Ceplene from EpiCept, covering Europe, Australia, and certain Asian markets including Japan and China. In October 2008, Ceplene was approved in the EU for remission maintenance therapy and prevention of relapse in adult patients with acute myeloid leukemia (AML). It is currently under review at the FDA, Health Canada, and other regulatory agencies, EpiCept reports.
Once Ceplene is launched, EpiCept is entitled to another $2 million fee and $5 million as a regulatory milestone. Sales-based milestones of $10 million and $20 million will be due once Ceplene reaches annual sales of $50 million and $100 million, respectively. EpiCept will also receive a double-digit royalty on net sales.
Epicept reported in December 2009 that it would initiate a Phase I/II study to evaluate the effects of Ceplene and low-dose interleukin-2 (IL-2) in combination with Gleevec on the eradication of minimal residual disease in adult patients with chronic myeloid leukemia. A study to examine the effects of Ceplene/IL-2 in combination with Vidaza in the treatment of patients with higher risk myelodsyplastic syndromes, a bone marrow disease that can progress to AML, is also in the works.