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

Canadian Approval Is World's First Regulatory Approval for SIMPONI

HORSHAM, Pa. and KENILWORTH, N.J., April 13 /PRNewswire-FirstCall/ Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that Health Canada has granted approval of SIMPONI (TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). With this approval in Canada, SIMPONI, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms in adult patients with moderately to severely active RA; reducing signs and symptoms in adult patients with moderately to severely active PsA, alone or in combination with MTX; and reducing signs and symptoms in adult patients with active AS who have had an inadequate response to conventional therapies. SIMPONI is the first biologic therapy to be approved concurrently in three distinct rheumatologic diseases. Schering-Plough anticipates that the medication will become available in Canada in the second half of 2009.

"This first approval marks a major milestone in the clinical development program for SIMPONI," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. "More importantly, the approval of SIMPONI expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly."

"This is the first approval for SIMPONI, one of the five stars in our late-stage pipeline," said Thomas P. Koestler, Ph.D., executive vice president, Schering-Plough Corporation and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, SIMPONI will provide an impor
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SOURCE Centocor Ortho Biotech Inc.; Schering-Plough Corporation
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