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
|SOURCE Centocor Ortho Biotech Inc.; Schering-Plough Corporation|
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