FOR IMMEDIATE RELEASE
May 18, 2009
SymBio Pharmaceuticals Limited
Eisai Co. Ltd.
SymBio Pharmaceuticals Limited and Eisai Co., Ltd. Conclude License Agreementfor Bendamustine Hydrochloride (SyB L-0501) in Korea and Singapore
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 andmarketing 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 toinitial treatment, making further treatment difficult despite a long overall survival period.
Through this partnership, SymBio will accelerate expansion of its pharmaceutical businessin 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 receiving US
FDA (Food and Drug Administration) approval 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, withconfirmation by an Independent Review Meeting that all the cases were “evaluable” in Marchof this year. SymBio and Eisai are currently advancing preparation towards the filing of theNDA 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 intandem 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]
Contacts
SymBio Pharmaceuticals Limited
Tatsuya Yoneyama, Business Development
Phone: +81-3-5472-1123

Eisai Co.、 Ltd.
Public Relations
Phone: +81-3-3817-5120

<Note to Editor>
1. Bendamustine hydrochlorideSymBio

Pharmaceuticals

Limitedhas

acquiredexclusive

rightsforthedevelopment

andcommercialization 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-Hodgkin’s 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 andrelapsed 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, whopreviously served as both Corporate Vice President of Amgen Ltd. and President of Amgen Japan. The
company’s 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 amutually 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 www.symbiosis.co.jp/en/index.html
3. Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human healthcare (hhc) company that discovers, develops andmarkets 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 participatesin all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please
visit www.eisai.co.jp/index-e.html