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SIMPONI(TM) (golimumab) Receives European Approval as Once-Monthly Subcutaneous Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis with Novel SmartJect(TM) Autoinjector
Date:10/6/2009

HORSHAM, Pa. and KENILWORTH, N.J., Oct. 6 /PRNewswire/ -- Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the European Commission has approved SIMPONI(TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).

In the European Union, SIMPONI is approved as a 50 mg subcutaneous injection once a month and is indicated:

  • In combination with methotrexate, for the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
  • Alone or in combination with methotrexate, for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
  • For the treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.

Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen. Centocor Ortho Biotech, Janssen-Cilag and Xian-Janss
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SOURCE Schering-Plough Corporation
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