SymBio Pharmaceuticals Limited and Eisai Co., Ltd. Conclude License Agreement for Bendamustine Hydrochloride (SyB L-0501) in Korea and Singapore

SymBio Pharmaceuticals Limited
Eisai Co., Ltd.

SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President and CEO: Fuminori Yoshida, “SymBio”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO, Haruo Naito, “Eisai”) announced today that the companies have concluded an exclusive license agreement on development and marketing for SyB L-0501 (bendamustine hydrochloride, “Bendamustine”). Under this agreement, SymBio shall grant exclusive development and marketing rights for Bendamustine to Eisai in both Korea and Singapore.

The estimated annual number of newly diagnosed patients with non-Hodgkin's lymphoma in Korea and Singapore is approximately 2300 and 300 patients, respectively. It is well-known that a large number of these patients are prone to relapse after responding to initial treatment, making further treatment difficult despite a long overall survival period.

Through this partnership, SymBio will accelerate expansion of its pharmaceutical business in Asia Pacific with Bendamustine as its first product in the region. Eisai, for its part, will work to begin its full-scale business deployment in the oncology area in Asia, including Korea and Singapore, with the addition of Bendamustine to its extensive in-house anticancer pipeline of products.

Bendamustine has been on the market in Germany for a number of years where it has been approved for use in non-Hodgkin's lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Bendamustine is being marketed in the United States as well after the US FDA (Food and Drug Administration) approved for the treatment of chronic lymphocytic leukemia in March 2008 and the treatment of patients with relapsed indolent B-cell non-Hodgkin's lymphoma in October of the same year. In Japan, SymBio has completed its Phase Ⅱ study for indolent non-Hodgkin's lymphoma and Mantle cell lymphoma, with confirmation by an Independent Review Meeting that all the cases were “evaluable” in March of this year. SymBio and Eisai are currently advancing preparation towards the filing of the NDA for Bendamustine with the Japanese regulatory authorities by the end of fiscal year 2009.

In a collaborative effort to address unmet medical needs, SymBio and Eisai will work in tandem to expedite the development of Bendamustine so that it will be available for use by patients and healthcare professionals in Korea and Singapore as early as possible.

[Please refer to the following notes for product and company profiles]


< Notes to Editors >

1. Bendamustine hydrochloride

SymBio Pharmaceuticals Limited has acquired exclusive rights for the development and commercialization of bendamustine hydrochloride in Japan, China, Korea, Taiwan and Singapore from Astellas Pharma GmbH (currently Astellas Deutschland GmbH, Munich, Germany). This agent was originally synthesized by Jenapharm, a German (formerly ‘East German’) pharmaceutical company, and is currently being used in Germany for the treatment of non-Hodgkins lymphoma, multiple myeloma and chronic lymphocytic leukemia under the trade name of Ribomustin®. In the US, it has been approved by the FDA and is on the market for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma under the trademark of TREANDA®.

2. SymBio Pharmaceuticals Limited

SymBio Pharmaceuticals Limited was established in March 2005 by Fuminori Yoshida, who previously served as both Corporate Vice President of Amgen Ltd. and President of Amgen Japan. The companys underlying corporate philosophy is “delivering hope to patients in need,” and the company aims to address the unmet medical needs of patients in Japan and Asia Pacific region by cultivating a mutually beneficial or symbiotic relationship among key players in the healthcare industry (i.e. physicians, scientists, investors, government, and patients). For more information about SymBio Pharmaceuticals Limited, please visit

3. Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human healthcare (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, including oncotherapy and supportive-care treatments; and immunology and vascular disease. Through a global network of research facilities, manufacturing sites and marketing affiliates, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit Window)