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SIMPONI(TM) (golimumab) Receives European Approval as Once-Monthly Subcutaneous Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis with Novel SmartJect(TM) Autoinjector
Date:10/6/2009

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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. SIMPONI is the first once monthly subcutaneous therapy approved in the U.S., European Union and Canada for the treatment of three rheumatic conditions: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The approved dose for SIMPONI in the U.S., European Union and Canada is a 50 mg subcutaneous injection given once a month either through the SIMPONI SmartJect(TM) auto injector or a prefilled syringe.

Important Safety Information

In the European Union, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients. Serious infections, including sepsis, pneumonia, tuberculosis, invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI. Some of the
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SOURCE Schering-Plough Corporation
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1. SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
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3. 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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