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SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:4/24/2009

d signs and symptoms of active psoriatic arthritis. Similarly, a Phase 3 study evaluating SIMPONI in the treatment of ankylosing spondylitis showed that SIMPONI 50 mg significantly improved signs and symptoms of active ankylosing spondylitis. Patients with psoriatic arthritis and ankylosing spondylitis experienced rapid and sustained improvements with continuous SIMPONI treatment.

"With the approval of SIMPONI, we enhance our commitment to delivering effective and innovative treatments to the millions of patients living with chronic inflammatory diseases while expanding our immunology portfolio," said Kim Taylor, President, Centocor Ortho Biotech Inc. "Importantly, as patient safety remains our top priority, we have collaborated with the FDA to develop a Risk Evaluation and Mitigation Strategy to help ensure the risks of ant-TNF therapy are appropriately managed by doctors prescribing and patients receiving SIMPONI."

"The approval of new and effective treatment options is always good news for the arthritis community, as not all patients respond the same to currently available treatment options," said Dr. John Hardin, Chief Scientific Officer for the Arthritis Foundation. "Anti-TNF agents have become an important advancement in the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, and each approval offers physicians and patients yet another option within this important class of therapy."

About Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis affect more than three million Americans collectively. RA is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information visit the '/>"/>

SOURCE Centocor Ortho Biotech Inc.
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