SAN FRANCISCO (Thomson Financial) - EpiCept Corp. said Thursday the European
Medicines Agency's scientific committee has issued a negative opinion on its
marketing authorization application for Ceplene for the remission maintenance
and prevention of relapse of patients with acute myeloid leukemia.
The European Committee for Medicinal Products for Human Use's opinion was
expected following the trend vote announced last month, the Tarrytown,
N.Y.-based specialty pharmaceutical company said.
The committee has asked for further data to support the results from the
Phase III clinical study of Ceplene, EpiCept said.
Based on input from the committee, the company said it believes it will be
able to obtain approval without having to conduct an additional confirmatory
Phase III trial.
EpiCept noted that there were no major safety concerns with the application.
Ceplene is designated as an orphan medicinal product in the European Union for
this indication.
The company said it has already requested a re-examination of the opinion
through the appeal procedure, and expects the appeal proceeding to take place in
the third quarter of this year.
Shares of EpiCept were down 21 cents, or about 28%, at 55 cents.
Katherine Hunt
kh/vj
COPYRIGHT
Copyright Thomson Financial News Limited 2007. All rights reserved.
The copying, republication or redistribution of Thomson Financial News Content,
including by framing or similar means, is expressly prohibited without the prior
written consent of Thomson Financial News.
|