EpiCept’s Ceplene Product Receives Marketing Auth. by European Commission

EpiCept Corporation (NASDAQ: EPCT and OTCQX: EPCT) is a pharmaceutical company that specializes in treating unmet medical needs in cancer therapy and pain management through its innovative technologies. The Company possesses a cancer product, Ceplene, approved in the European Union along with three other products, which stand as major clinical trial candidates: Amiket, Crobulin, and Azixa.


The European Commission has approved Ceplene for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In a Phase III clinical study of 320 patients, Ceplene met its primary endpoint of increased leukemia-free survival among AML patients in remission. The product has been granted orphan drug status for the treatment of AML by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

There are approximately 12,000 new cases of AML and 9,000 deaths caused by this cancer each year in the U.S. There are approximately 47,000 AML patients in the EU, with 16,400 new cases occurring each year. There are currently no other effective medical-based remission therapies for AML patients.

Financial Results

EpiCept Corporation announced operating and financial results for the three and nine months ended September 30, 2011, and provided an update with respect to the Company’s key business initiatives.

“During the third quarter of 2011, our R&D efforts were increasingly focused on regulatory matters regarding AmiKet and Ceplene,” stated Jack Talley, President and Chief Executive Officer of EpiCept. “Following the receipt in June of the U.S. Food and Drug Administration’s initial comments on our proposed Special Protocol Assessment (SPA) for Ceplene, in September we reported on the outcome of the meeting the Company held with the FDA to better understand the Agency’s position regarding the data required to re-file a new drug application (NDA)… We are critically reviewing both programs and, in light of all the available information, will determine soon which program should be pursued as our lead opportunity.” For the full release, please click here.

EpiCept will be presenting its products and technologies at OneMedForum SF 2012, on January 9 – 12.

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