SymBio and Eisai to Launch Symbenda® (Bendamustine Hydrochloride) in Singapore for the Treatment of Low-grade Non-Hodgkin's Lymphoma and Chronic Lymphatic Leukemia

SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President & CEO: Fuminori Yoshida, “SymBio”) and Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that Eisai's Singapore subsidiary Eisai (Singapore) Pte. Ltd. launched bendamustine hydrochloride (“bendamustine”) in Singapore under the brand name Symbenda® as a treatment for low-grade non-Hodgkins lymphoma and chronic lymphatic leukemia.

Bendamustine is the subject of a license agreement concluded between the two companies in May 2009, in which SymBio granted Eisai the exclusive rights to develop and market the agent in Singapore and South Korea. A regulatory application seeking approval of bendamustine was submitted to the Singapore health authorities (Health Sciences Authority: HSA) by SymBio on December 24, 2008 and was approved on January 20, 2010. The product will be marketed by Eisai (Singapore) Pte. Ltd.

Approximately 300 people in Singapore are newly diagnosed with non-Hodgkin's lymphoma each year. It is well-known that many low-grade non-Hodgkin's lymphoma patients are prone to repeated relapse after responding to initial treatment, making further treatment difficult despite extended overall survival.

Bendamustine has been used for many years in Germany as a treatment for non-Hodgkin's lymphoma, multiple myeloma and chronic lymphatic leukemia. It is also available in the United States, where it was approved by the U.S. Food and Drug Administration in March 2008 for the treatment for chronic lymphatic leukemia and in October the same year for the treatment of relapsed indolent B-cell non-Hodgkin's lymphoma. In Japan, SymBio submitted a Marketing Authorization Application to the Japanese Ministry of Health, Labour and Welfare seeking approval of bendamustine for the treatment of recurrent or refractory low-grade non-Hodgkin's' lymphoma and mantle cell lymphoma. On August 30, 2010, the Pharmaceutical Affairs Committee of the Ministry's Pharmaceutical Affairs and Food Sanitation Council recommended bendamustine for final approval. If approved, Eisai will market the drug exclusively in Japan.

By launching bendamustine in Singapore, SymBio and Eisai seek to provide a new treatment option for low-grade non-Hodgkin's lymphoma and chronic lymphatic leukemia, thereby making further contributions to improving the quality of life of patients living with these diseases.