Wednesday, June 13, 2007

MabThera shows stable long-term arthritis safety

BARCELONA, June 13 (Reuters) - Roche Holding AG's (ROG.VX: Quote, Profile, Research) MabThera can deliver sustained benefits to rheumatoid arthritis patients and, significantly, its safety profile is unchanged even after multiple treatments, researchers said on Wednesday.

MabThera, already a top-selling cancer drug, is now also approved for use in rheumatoid arthritis and could be used in several other autoimmune diseases, such as lupus and multiple sclerosis.

It is likely to be given for longer periods in these conditions, raising concerns about potential side effects -- particularly infections, since the drug works by targeting B-cells in the immune system.

Data presented at the annual European Congress of Rheumatology, however, showed a low and unchanging rate of serious infections in patients receiving up to seven treatment courses at six- to 12-month intervals.

Follow-up results from a clinical study involving more than 1,000 patients also found the effectiveness of the drug in relieving symptoms was sustained or further improved with subsequent doses.

The data showed that after three courses of MabThera in patients who had an inadequate response to another class of biotech drugs, known as TNF inhibitors, the number achieving a 70-percent improvement in symptoms rose to 25 percent from 11 percent.

Edward Keystone, professor of medicine at the University of Toronto, who has worked with Roche in researching MabThera, said the long-term findings would allow physicians to make treatment decisions with confidence.

MabThera -- known as Rituxan in the United States, where it is sold by Genentech Inc. (DNA.N: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) -- is one of a number of new drugs for rheumatoid arthritis -- is one of a number of new drugs for rheumatoid arthritis recently approved or in late-stage development.

Roche believes worldwide sales of MabThera, already a blockbuster in cancer, could also eventually top $1 billion a year in rheumatoid arthritis and other autoimmune diseases.

The Swiss group has made rheumatoid arthritis a priority for the future and hopes it will become a major driver of the business in the years ahead.

Roche is also developing a second novel medicine for the crippling disease, called Actemra, which could get to market in 2008. Behind that, it has an antibody drug called ocrelizumab that is just entering final Phase III development.

((Reporting by Ben Hirschler; Editing by Louise Ireland; email:; Reuters Messaging:; +44 20 7542 5082)) Keywords: ARTHRITIS ROCHE/

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