Nov 9 2009
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Health Canada has accepted for review the Company’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.
"We are pleased to have completed another key milestone in our North American regulatory strategy for Ceplene®," stated Jack Talley, President and Chief Executive Officer of EpiCept. "As the next step in this process, we are focused on the filing of a New Drug Application for Ceplene® with the U.S. Food and Drug Administration 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."
EpiCept also announced today 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 Ltd., filed the application and will market Ceplene® upon approval. A decision on this application is anticipated late next year.
Ceplene® is approved in the European Union 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®. In June 2009 EpiCept launched a named patient program for Ceplene® in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene®.