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Friday, July 25, 2008

EPCT - Epicept up 200% Pre Market Drug Approval

Today ECPT - Epicept is up over 200% on approval of Ceplene, one of their drugs.

Ceplene(R) Receives Positive European Opinion for Approval From CHMP

Marketing Authorization Normally Anticipated within 67 Days in the EU
Conference Call to be Held July 28 at 9:00 a.m. Eastern Time

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion regarding the marketing authorization for Ceplene® (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU
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