EpiCept Corporation has announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene® (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.
“The filing of the NDS for Ceplene® with Health Canada is a another key milestone for EpiCept and an important step in our North American regulatory strategy for this innovative new therapy,” stated Jack Talley, President and Chief Executive Officer of EpiCept. “We anticipate that we will also be in the position to file a New Drug Application with the U.S. Food and Drug Administration towards the end of this year, contingent upon planned discussions with the FDA.”
Ceplene® is currently 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 several prospective partners for the European marketing rights to Ceplene®. In June 2009, EpiCept announced that it had launched a named patient program for Ceplene® in partnership with IDIS and under which physicians in all major global markets excluding the U.S. can prescribe Ceplene® to patients.