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Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:4/13/2009

tant and convenient new treatment option to rheumatologists and their patients. SIMPONI expands our leading immunology franchise in meeting the needs of the rheumatology community."

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.

In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with RA, PsA and AS.

In June 2008, Centocor Ortho Biotech Inc. announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with active forms of RA, PsA and AS.

The approval of SIMPONI in Canada is based on data from five pivotal clinical trials: GO-BEFORE, GO-FORWARD, GO-AFTER, GO-REVEAL and GO-RAISE. Each trial found SIMPONI to be effective in reducing the signs and symptoms of RA, PsA and AS.

About Rheumatoid Arthritis

RA is a chronic and debilitating disease that affects approximately 4 million people in Canada. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, over time it can cause permanent joint deformity and severe disability. RA can occur at
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SOURCE Centocor Ortho Biotech Inc.; Schering-Plough Corporation
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