Centocor, Inc (HORSHAM, Pennsylvania) and Schering-Plough Corp (KENILWORTH, New Jersey) announced that a Marketing Authorization Application has been submitted to the European Medicines Agency requesting the approval of golimumab (CNTO 148), a next-generation human anti-TNFα monoclonal antibody, as a monthly subcutaneous treatment and as an intravenous infusion therapy for adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNFα. Pending regulatory approval in the EU, Schering will assume exclusive marketing rights for the agent in Europe.

Golimumab is currently in the most comprehensive phase III development program to date for an anti-TNFα biologic therapy. Primary endpoint study findings from the ‘Golimumab—A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody’ (GO-REVEAL) trial and the ‘Golimumab—A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks’ (GO-RAISE) trial were reported at the annual American College of Rheumatology meeting in November 2007. Phase III study findings evaluating the efficacy and safety of the agent in the treatment of >1400 adults with moderate-to-severe RA will be presented at the annual European League Against Rheumatism congress in June 2008.

Centocor discovered golimumab and has exclusive marketing rights to the agent in the US. Pending regulatory approval, Schering will assume exclusive marketing rights outside the US except in Japan, Indonesia, and Taiwan, where the agent will be comarketed by Mitsubishi Tanabe Pharma Corp and Janssen Pharmaceutical Kabushiki Kaisha. The agent will be exclusively marketed in Hong Kong by Janssen-Cilag, and in China by Xian-Janssen Pharmaceutical Ltd.