SymBio and Eisai to Launch Symbenda® (Bendamustine Hydrochloride) in Singapore for the Treatment of Low-grade Non-Hodgkins Lymphoma and Chronic Lymphatic Leukemia
SymBio Pharmaceuticals Limited
Eisai Co., Ltd.
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-Hodgkins lymphoma each year. It is well-known that many low-grade non-Hodgkins 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-Hodgkins 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-Hodgkins 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-Hodgkins lymphoma and mantle cell lymphoma. On August 30, 2010, the Pharmaceutical Affairs Committee of the Ministrys 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-Hodgkins lymphoma and chronic lymphatic leukemia, thereby making further contributions to improving the quality of life of patients living with these diseases.
[ Please see the following notes for further information on bendamustine hydrochloride, SymBio and Eisai ]
< Notes to editors >
1. About Bendamustine Hydrochloride
SymBio Pharmaceuticals Limited acquired the exclusive rights to develop and market bendamustine hydrochloride in Japan, China, South Korea, Taiwan and Singapore from Astellas Deutschland GmbH (Headquarters: Munich, Germany, formerly Astellas Pharma GmbH). Bendamustine was originally synthesized by German (formerly ‘East German’) pharmaceutical company Jenapharm and is currently marketed in Germany under the brand name of Ribomustin as a treatment for non-Hodgkins lymphoma, multiple myeloma and chronic lymphocytic leukemia. In the United States, the product has been approved by the U.S. Food and Drug Administration and is currently prescribed under the brand name Treanda® for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma
2. About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Limited was established in March 2005 by Fuminori Yoshida, who previously served as 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 the 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 www.symbiosis.co.jp/en/index.html
3. About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (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, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.co.jp/index-e.html