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news.Meda has in-licensed exclusive rights to Ceplene (histamine dihydrochloride) from EpiCept. Meda’s rights cover Europe and several key markets in Asia including Japan, China and Australia.
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Ceplene is indicated for remission maintenance therapy and prevention of relapse in adult patients with acute myeloid leukemia (AML). In a multicenter 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 significant (p<0.008). Ceplene is approved by the European Commission as an orphan drug.
Anders Lonner, CEO of Meda, said: “Ceplene is a unique drug and we hope that Ceplene will be able to help patients that today have few alternatives. There is also a good fit with our pain product, Onsolis, indicated for breakthrough pain in cancer patients.”
Ceplene is also under investigation for additional indications such as myelodysplastic syndrome (MDS) and chronic myelogenous leukemia (CML).
In consideration of being granted the exclusive rights to Ceplene, Meda will pay EpiCept $3m upfront and an additional $2m upon launch. EpiCept is also eligible to receive $5m as a regulatory milestone. Sales-based milestones will be due once Ceplene reaches annual sales of $50m and $100m. The milestone payments for those sales levels are $10m and $20m, respectively. EpiCept will receive a royalty on net sales.