Centocor, Inc, has announced that the Committee for Medicinal Products for Human Use, part of the European Union's European Medicines Agency (EMEA), has recommended the approval of an expanded indication for Remicade® (infliximab) to include treatment of moderate to severely active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy or who are intolerant of or have medical contraindications to such therapies.

Centocor, which developed Remicade, has exclusive marketing rights to the drug in the US. If EMEA grants marketing authorization, Remicade would be the first biologic therapy approved to treat moderately to severely active UC in the 25 member states of the European Union, as well as Iceland and Norway.

Remicade is a chimeric IgG1 anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody composed of human constant and murine variable regions, and is the only anti-TNF biologic administered by intravenous infusion.

Centocor, in partnership with Schering-Plough, is also developing golimumab (CNTO 148), a fully human anti-TNF-α IgG1 monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-α. Golimumab, which is currently being investigated for administration by either subcutaneous injection or intravenous infusion, has demonstrated promise in a phase II clinical study for the treatment of rheumatoid arthritis.

Schering-Plough markets Remicade in all countries outside of the US, except in Japan and other East Asian countries, where Tanabe Seiyaku, Ltd, markets the drug, and in the People's Republic of China, where Xian-Janssen owns the marketing rights.

Schering-Plough reported that sales of Remicade increased 26% to $900,000 million in 2005. Separately, Johnson & Johnson reported that worldwide sales (including all markets) of Remicade surpassed $2.5 billion in 2005, versus $2.1 billion in 2004. US sales were $2.1 billion in 2005, versus $1.8 billion in 2004. The agent has been used to treat nearly 700,000 patients worldwide.

Centocor is a wholly owned subsidiary of Johnson & Johnson.

—A. Techman