EpiCept, Meda enter into exclusive commercialization agreement for Ceplene

EpiCept CorporationJan 11 2010

“This agreement represents a significant milestone for EpiCept and welcome news for patients suffering from AML in Europe, who will now be able to readily access this life saving medicine once launched”

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that it has entered into an exclusive commercialization agreement for Ceplene^® (histamine dihydrochloride) with Meda AB, (OMX Nordic Exchange: MEDA-A-ST) a leading international specialty pharmaceutical company based in Stockholm. Ceplene is EpiCept’s novel therapy approved in the European Union with orphan drug status for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.

Meda is a leading international specialty pharmaceutical company with products sold in 120 countries worldwide. The company has its own sales organizations in the U.S. and more than 40 other countries, including a marketing organization of about 1,200 people throughout Europe. Meda’s annual sales is currently approximately $1.8 billion with several products in the cancer area, including Onsolis®, indicated for breakthrough pain in cancer patients.

Under the terms of the agreement, EpiCept will grant Meda the right to market Ceplene in Europe and several other countries including Japan, China, and Australia. EpiCept will receive a $3 million fee and an additional $2 million upon the first commercial launch of Ceplene in a major European market, which is expected later this year. Additional payments include a $5 million payment upon achievement of a regulatory milestone and up to $30 million in sales-based milestones that commence upon attainment of at least $50 million in annual sales. EpiCept will receive a double digit percent royalty on net sales in the covered territories and will be responsible for Ceplene’s commercial supply.

“This agreement represents a significant milestone for EpiCept and welcome news for patients suffering from AML in Europe, who will now be able to readily access this life saving medicine once launched,” remarked Jack Talley, president and CEO of EpiCept. “Meda's strengths and assets are exactly those that we sought from the start of our selection process, including vast marketing and distribution coverage throughout Europe and a deep knowledge of and relationships within the oncology space. From a corporate perspective, we believe this agreement provides us with the resources needed to continue our growth as a commercial enterprise with a host of near-term and long-term value drivers. It also will allow us to more fully focus on preparing our new drug application to the U.S. Food and Drug Administration for Ceplene later this year, and on expanding its use in other hematologic malignancies. We look forward to working closely with Meda in the commercialization of Ceplene.”