Sep 3 2009
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Ceplene® (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union. One report, issued by the U.K. publication Mednous, said that Ceplene® was one of 12 products “expected to confer major public health benefits,” while the European Medicines Agency (EMEA), in its summary of the annual report for 2008, stated, “Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include: the first medicine for use as a maintenance treatment in adults with acute myeloid leukemia…”
“We are gratified that Ceplene® has been recognized for its importance in providing a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients in first remission,” stated Jack Talley, President and Chief Executive Officer of EpiCept. “We believe that Ceplene® is poised to make a major contribution to the management of this deadly disease. As such, we are making it available on a named patient basis essentially worldwide, with the exception of the United States. In the United States we are continuing our preparation of a New Drug Application or NDA for submission to the FDA."
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 several 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®.