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SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:6/26/2009

Phase 3 rheumatoid arthritis trials, SIMPONI was shown to be effective regardless of prior treatment experience, which included patients inadequately responding to methotrexate and patients previously treated with anti-TNF agents.

Centocor Ortho Biotech Inc. developed and discovered golimumab 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 golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China, where golimumab will be exclusively marketed by Xian-Janssen.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic and debilitating disease that affects more than three million people in Europe. 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 any age, but is most common in adults 30-50 years old and is two-to-three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation over time. The Arthritis Research Campaign estimates one in 50 people have psoriasis. Of these, about one in 14 will develop PsA. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees
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SOURCE Schering-Plough Corporation; Centocor Ortho Biotech Inc.
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1. New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients
2. Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
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