The orphan drug designation follows adoption of a positive opinion by the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products.
Orphan drug designation in the EU may provide several benefits for Ceplene (histamine dihydrochloride), including ten years marketing exclusivity throughout Europe in acute myeloid leukemia, reduced fees, and access to EU research funding grants.
“The granting of orphan drug status of Ceplene for the treatment of acute myeloid leukemia patients in complete remission recognizes the need for new therapeutic options. This is a positive event for our efforts to seek a partner to continue Ceplene development in Europe and the US,” commented Larry Stambaugh, president and CEO of Maxim.
Maxim has completed a phase III study of Ceplene plus IL-2 (Proleukin) in patients with acute myeloid leukemia, in which the treatment group met the primary endpoint of the trial, leukemia-free survival.