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news.EpiCept has earned a $2m payment from Meda for the first commercial shipment of Ceplene (histamine dihydrochloride) to a major country in the EU, as defined in the agreement.
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The milestone payment is part of an exclusive commercial licensing agreement for Ceplene with Meda in Europe and certain Pacific Rim countries signed by the two companies in January, 2010.
Under the agreement, EpiCept is eligible to receive a $5m payment upon achievement of a regulatory milestone and up to $30m in sales-based milestones that commence upon attainment of at least $50m in annual sales. EpiCept also receives a double digit percent royalty on net sales in the covered territories.
Ceplene is EpiCept’s therapy approved in the EU with orphan drug status for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.
Ceplene is used together with low dose Interleukin-2. 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.