EpiCept is pleased to announce that Ceplene® (histamine dihydrochloride) is now available to patients with acute myeloid leukemia (AML) worldwide, with the exception of the United States, via a “Named Patient Program.”

A Named Patient Program is a compassionate use drug supply program through which patients can be prescribed investigational or approved drugs prior to their commercial launch through a legal and ethical channel.

The initiation of this program follows the recent approval of Ceplene in Europe by the European Medicines Evaluation Agency (EMEA). As authorized by the EMEA, Ceplene is indicated as maintenance therapy for adult patients with AML in first remission (CR1) concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.

Licensed healtcare professionals in areas outside of the United States who are treating AML patients and who are interested in Ceplene should contact our international partner:

MEDA Pharma GmbH & Co KG
Supply Chain Services
Tel: +49 6172 888 2742
Fax: +49 6172 888 2799
Email: claudia.bien@medapharma.de