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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

, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages of 30 and 50, in the peak of their productive years.

About Ankylosing Spondylitis

Ankylosing spondylitis is a painful and progressive form of spinal arthritis, and symptoms of inflammatory back pain often first present in people under the age of 35 years. On the European continent, it is estimated that prevalence ranges from 0.2 to one percent of the entire population. It typically begins in the late teens and early 20s, and in severe cases can result in fusing of the spinal vertebrae and cause structural damage to hips and other joints. Often misdiagnosed as "just back pain" or undifferentiated arthritis, AS is a systemic inflammatory disease that, in addition to its effect on the spine, can affect internal organs, peripheral joints and vision.

About SIMPONI

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Upon approval in the European Union, SIMPONI will be the first once-monthly subcutaneous anti-TNF-alpha therapy for the treatment of moderate-to-severe, active RA, active and progressive PsA and severe, active AS, and will be available either through the SIMPONI SmartJect(TM) auto injector or a prefilled syringe. The approved dose for SIMPONI in the US and Canada is a 50 mg subcutaneous injection given once a month.

Important Safety Information

In Europe, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, oppo
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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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