Health Canada Accepts EpiCept’s Ceplene Application For Review

The Health Canada has accepted for review EpiCept’s New Drug Submission (NDS) for Ceplene (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission. Health Canada’s performance target for the completion of review and a decision is within 300 days.

Ceplene is approved in the EU for the remission maintenance and prevention of relapse in patients with AML in first remission. The company is continuing negotiations with prospective partners for the European marketing rights to Ceplene.

The company also announced that Israel’s Ministry of Health has accepted a marketing application for Ceplene for the remission maintenance of AML patients in first remission. The company’s distribution and marketing partner for Ceplene in Israel, Megapharm has filed the application and will market Ceplene upon approval. A decision on this application is anticipated late next year.

Jack Talley, president and CEO of EpiCept, said: “We are pleased to have completed another key milestone in our North American regulatory strategy for Ceplene, as the next step in this process, we are focused on the filing of a New Drug Application for Ceplene with the FDA for AML remission maintenance. As previously stated, we intend to utilize the approval of Ceplene in order to establish a fully integrated specialty pharmaceutical company focused in hematology in North America.”