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First-in-class indication expected for Remicade

Published on 18/01/06 at 11:38am

Schering-Plough expects its arthritis treatment Remicade to receive European approval to treat ulcerative colitis in early 2006.

If approved Remicade (infliximab) would be the first biologic, and the first in its TNF-blocker class, to gain this indication.

The TNF-blocker market is a highly competitive one with two other treatments competing with Remicade for sales - Wyeth and Amgen's Enbrel (etanercept) and Abbott's Humira (adalimumab).

All three manufacturers have followed similar strategies of pursuing multiple indications for their TNF-blocker drugs, but Schering-Plough is the only one to pursue an indication for UC.

US regulators approved Remicade to treat UC in September 2005 and Schering-Plough is backing up its European application with clinical trials of patients that have failed to improve using standard UC treatments. Over 700 patients who were unresponsive to at least one standard therapy - a steroid, GlaxoSmithKline's Imuran (azathioprine) or both together - were enrolled in the ACT 1 and ACT 2 clinical trials.

The trials then compared a group of these patients taking Remicade to a control group that just took a placebo. Against the control group about 60% of Remicade patients achieved mucosal healing - healing of the lining of the colon.

Lead investigator of the ACT 1 trial Paul Rutgeerts said: "Results achieved with Remicade in patients with UC were significantly better than results in patients receiving conventional therapy. These findings should raise our treatment expectation."

Remicade was the second TNF-blocker to come to market after Enbrel. The third and newest TNF-blocker on the market, Humira, was first approved in 2002. In 2004 Enbrel led the global market with sales of $2.5 billion, ahead of Remicade with $2 billion and Humira with $850 million.

Remicade received EU approval to treat moderate to severe plaque psoriasis in October 2005, adding to its other indications: Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

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