“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.”