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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

ice President, Clinical R&D, Centocor Research & Development, Inc. "We are optimistic that SIMPONI will be a welcome addition as a new anti-TNF treatment option for rheumatologists, and adults living with these inflammatory conditions who are seeking an effective and convenient therapy."

Upon receipt of the corresponding Commission Decision, SIMPONI will be 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 will be 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.

The CHMP recommendation serves as the basis for a European Commission approval decision. A Commission approval of this application will result in Marketing Authorization with unified labeling that will be valid in all European Union Member States.

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.

"This positive opinion is an important step toward an approval as SIMPONI has the potential to benefit a broad range of patients in Europe by offering once-monthly subcutaneous treatment administered through an autoinjector device designed specifically with arthritis patients in mind," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "Schering-Plough continues to pride itself on being a leading provider of rheumatic disease therapies within the European rheumatology community."

The efficacy and safety of SIMPONI have been studied in a comprehensive Phase 3 development program that included more than 2,000 patients living with moderately to severely active RA, active PsA and active AS. In
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SOURCE Schering-Plough Corporation; Centocor Ortho Biotech Inc.
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