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SymBio Pharmaceuticals and Eisai Sign License Agreement for bendamustine hydrochloride (SyB L-0501)

TOKYO, Aug. 18, 2008--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 the license agreement for the co-development and commercialization of bendamustine hydrochloride in Japan, with exclusive rights retained by SymBio.

Based on this agreement, SymBio shall grant co-development and exclusive commercialization rights to Eisai and, in return, receive upfront and development milestone payments of up to 4 billion yen in total. In addition, the companies plan to move forward with the development of several target indications through co-development.

In Germany, bendamustine hydrochloride has been used extensively for the treatment of non-Hodgkin's lymphoma, multiple myeloma and chronic lymphocytic leukemia. The drug has been on the market in the United States since April of this year after receiving FDA approval in March 2008 for the treatment of chronic lymphocytic leukemia. In Japan, bendamustine hydrochloride is currently being investigated in patients with low-grade non-Hodgkin's lymphoma, and is in the pivotal stage of clinical development prior to submission for approval.

The estimated annual incidence of non-Hodgkin's lymphoma in Japan is approximately 15,000, and it is well-known that a large number of these patients are prone to relapse after responding to initial treatment, making further treatment difficult even though the overall survival period tends to be long.

By entering into this alliance with Eisai, which also focuses on oncology as one of its strategic therapeutic areas, SymBio aims to accelerate its business expansion efforts and maximize the market potential of bendamustine hydrochloride in Japan. Eisai, for its part, will further strengthen its full-scale business deployment in the oncology area in Japan with the addition of this drug to its extensive in-house anti-cancer pipeline products.

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


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Posted: August 2008