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Centocor, Schering-Plough Submit Golimumab MAA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Centocor, Inc. and Schering-Plough have submitted a Marketing Authorization Application (MAA) to the EMEA requesting the approval of golimumab (CNTO 148) as a monthly intravenous (IV) infusion therapy for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase III development programs for golimumab, an anti-tumor necrosis factor (TNF)- alpha monoclonal antibody, marks the first time that an MAA has been submitted for three unique disease states.

Schering-Plough will assume exclusive marketing rights for golimumab in Europe, pending approval in the EU
   
“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 R&D, Centocor, Inc. “We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008.”

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