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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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"With this approval, Schering-Plough can now bring SIMPONI, one of the five stars in our development pipeline, to market in Europe," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, SIMPONI will provide an important and convenient new treatment option to rheumatologists and their patients. SIMPONI expands upon our leading immunology franchise in meeting the needs of the rheumatology community."

SIMPONI is the first and only once-monthly subcutaneous anti-tumor necrosis factor (TNF)-alpha therapy approved in Europe for the simultaneous treatment of RA, PsA, and AS. SIMPONI is available in two device forms, either through the SmartJect(TM), a novel autoinjector designed to meet the needs of arthritis patients, or as a prefilled syringe.

"SIMPONI has been shown to significantly reduce the signs and symptoms and improve physical function of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, three debilitating rheumatic diseases," said Iain B. McInnes, MD, PhD, FRCP, Professor of Experimental Medicine, University of Glasgow, study investigator. "With this approval, rheumatologists and patients now have an effective once-monthly subcutaneous anti-TNF therapy for the treatment of these rheumatic diseases."

The Commission Decision follows a positive opinion adopted on June 25, 2009, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) and results in marketing authorization with unified labeling that is valid in the current EU 27 member states as well as in Iceland and Norway. In April 2009, SIMPONI(TM) (golimumab) was approved by the U.S. Food and Drug Administration (FDA) and Health Canada for the treatment of moderately to severely active RA, active PsA and active AS.

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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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