August 2016

The anticancer agent Treakisym for Injection 100 mg (bendamustine hydrochloride, "Treakisym") has been approved in Japan for an additional indication of chronic lymphocytic leukaemia (CLL). Treakisym is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited.

Treakisym was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.

Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labour and Welfare's Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Chronic lymphocytic leukaemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukaemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, Treakisym has been designated as an orphan drug for chronic lymphocytic leukaemia in Japan.

Eisai positions oncology as a key therapeutic area and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of Treakisym as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.

Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly 'East German') pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukaemia. In the United States the product has been approved by the US Food and Drug Administration and is currently marketed under the brand name Treanda for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma. Eisai concluded an exclusive licensing agreement with SymBio in August 2008 concerning the joint development and marketing of Treakisym in Japan, which was followed by a subsequent agreement between the two companies in May 2009 concerning the development and marketing of the agent in Singapore and South Korea.

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