Germany will be the second country in the EU in which Ceplene will be commercially available, following the product’s launch in the UK in April, 2010. Ceplene is expected to be shipped in cartons of 14 vials (enough for 1 week’s therapy).
The launch is being conducted by Meda, as part of an exclusive commercialisation agreement for Ceplene signed by the two companies in January 2010.
Meda is an international specialty pharmaceutical company with products sold in 120 countries worldwide and a marketing organisation of about 1,200 people throughout Europe.
Ceplene is indicated for remission maintenance therapy and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML). Ceplene is used together with low dose Interleukin-2.
EpiCept claimed that in an international, multicenter, open-label, randomised Phase III study, Ceplene met its primary endpoint of prolonging leukemia-free survival for AML patients in remission.