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SymBio Launches TREAKISYM® in Japan

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SymBio Pharmaceuticals Limited has announced the launch of TREAKISYM® in Japan for the treatment of refractory/relapsed low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. This marks the achievement of a major corporate milestone in SymBio’s history, transforming the company into a biopharmaceutical company with solid product revenue in 2011.

In August, 2008, SymBio concluded a license agreement with Eisai Co., Ltd. for the co-development and commercialization of TREAKISYM in Japan. In accordance with the agreement, Eisai has assembled a team of dedicated oncology-focused liaisons to oversee each major market area in Japan along with 1,400 medical reps to promote and detail TREAKISYM®.

TREAKISYM® is the first oncology drug in-licensed by SymBio (December, 2005) for development and commercialization in Japan and other key Asia Pacific markets. The Ministry of Health, Labour and Welfare (MHLW) approved the company’s New Drug Application for TREAKISYM® on October 27th this year.

Flawless execution and nimbleness has enabled SymBio to shorten time to market for TREAKISYM®, only requiring 4 years from first patient enrolled to market approval. This short development timeline to market approval has enabled SymBio to markedly reduce the drug lag between the US launch of TREANDA® and Japan launch of TREAKISYM® to two years, and to almost zero drug lag between the European and Japan launches.

Fuminori Yoshida, President and CEO of SymBio, said, “I am extremely pleased that as a result of the dedication and commitment invested by our people at SymBio, we have succeeded in significantly shortening the drug lag between the launch of bendamustine in Japan and other countries to deliver this much-needed cancer drug to patients as early as possible. The availability of this drug in Japan will greatly help non-Hodgkin's lymphoma and mantle cell lymphoma patients who have suffered needlessly due to the lack of effective treatment. This major achievement embodies the culmination of our efforts since the company’s inception in 2005 with the corporate mission of addressing the unmet medical needs of patients.”

As part of ongoing label expansion plans and through its collaboration with Eisai for future development, SymBio initiated two additional phase 2 studies in 2010 for TREAKISYM®; enrollment is currently underway for a Japan-Korea joint phase 2 trial of bendamustine in combination with rituximab for the treatment of refractory and relapsed aggressive NHL, and as first-line treatment in a phase 2 trial in untreated multiple myeloma patients.

SymBio will continue to expand the use of TREAKISYM® in the hematology space as nimbly as possible in order to address the unmet medical needs of patients as its business presence in Asia Pacific continues to gain momentum, and key pieces of the company’s strategic development and commercialization plan fall into place upon the completion of important milestones.