Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing S...( HORSHAM Pa. and KENILWORTH N.J. M...)

HORSHAM, Pa. and KENILWORTH, N.J., March 18 /PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-tumor necrosis factor (TNF)- alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval in the European Union, Schering-Plough Corporation (NYSE: SGP) will assume exclusive marketing rights for golimumab in Europe.

"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."

Phase 3 primary endpoint study findings from the Golimumab - A
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