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New Anti-TNF Golimumab Significantly Reduced Signs and Symptoms of Ankylosing Spondylitis According to Phase 3 Study Findings
Date:11/7/2007

our percent of patients receiving golimumab 50 mg and six percent of patients receiving golimumab 100 mg experiencing a serious adverse event. Seven percent of patients receiving placebo experienced serious adverse events. Adverse events were reported in 80 percent of patients receiving golimumab and 77 percent of patients receiving placebo, with an increased incidence of infections, primarily upper respiratory infections, in patients treated with golimumab. Antibodies to golimumab were detected in four percent of patients through week 24.

About Golimumab

Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF- alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.

Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Schering-Plough has exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.

About Ankylosing Spondylitis

AS is a painful and progressive form of spinal arthritis, and symptoms of inflammatory back pain often first present in people under the age of 35 years. It typically begins in the late teens and early twenties and in severe cases can result in fusing of the spinal vertebrae and cause structural dam
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SOURCE Centocor, Inc.
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