Monday, July 1, 2013

Orencia Subcutaneous formulation appproved in Japan

Ono Pharmaceutical Co., Ltd. and Bristol-Myers K.K. announced that ORENCIA® Subcutaneous Injection 125mg/mL Syringe1mL (generic name: abatacept (genetic recombination); “ORENCIA® SC”) was approved today by the Ministry of Health, Labour and Welfare to be manufactured and marketed with an indication for rheumatoid arthritis (limited to cases where existing treatments are inadequate).

ORENCIA® SC comes in a prefilled syringe with a needle cover, which is expected to reduce the risk
of infection as the cover prevents needle sticks. The preparation takes into account the safety of both
healthcare workers and rheumatoid arthritis patients. ORENCIA® SC can also be self-administered
by the patient if that is judged as appropriate by physicians. Along with the preparation for
intravenous infusion which is already on the market, the addition of a new formulation for
subcutaneous injection is believed to allow patients to receive treatment tailored to their lifestyle and
contribute to increased convenience

Collaboration between Ono and BMKK

Ono and BMY KK concluded an agreement to jointly promote ORENCIA® in September 21, 2011, and, commenced co-promotion on June 4, 2013. The two companies have also been co-developing
ORENCIA®. With ORENCIA® IV and ORENCIA® SC, we will further contribute to the treatment of rheumatoid arthritis.

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