Anti-TNF blockbuster garners positive Phase III data

Schering-Plough, Johnson & Johnson and Medarex unveiled positive new data from two late-stage studies of golimumab, an experimental anti-TNF therapy designed to treat conditions related to rheumatoid arthritis. The data on reducing symptoms of psoriatic arthritis and ankylosing spondylitis was presented at the American College of Rheumatology meeting in Boston. Golimumab works by blocking tumor necrosis factor (TNF), an inflammatory protein. If approved, golimumab would join the ranks of such anti-TNF blockbusters as Enbrel, Humira and J&J's own Remicade. And the companies say they'll be well positioned to compete. Golimumab requires injections only once a month, compared to higher frequencies for those existing drugs.

Slightly more than half of the psoriatic arthritis patients taking a 50 mg dose reported a reduction of symptoms of 20 percent or more compared to 9 percent of the volunteers receiving a placebo. About 60 percent of the patients taking either the 50 mg or 100 mg dose of the drug reported a 20 percent or greater reduction in symptoms for ankylosing spondylitis after 14 weeks. Late-stage data on rheumatoid arthritis is expected next year, and J&J is planning NDAs on all three indications for 2008.

"The availability of treatments that target TNF-alpha have dramatically changed rheumatologists' approach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."

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