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Print Edition StoriesThursday, March 12, 2009
Biogen Idec’s cancer drug Rituxan fails in lupus trials
By Marc Songini
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Biotech giant Biogen Idec Inc. has reported a disappointing outcome for the Phase 3 clinical study of a new application for its established Rituxan therapeutic antibody.
Cambridge-based Biogen Idec (Nasdaq:BIIB) and its partner, Calif.-based Genentech Inc., reported that the study of Rituxan applied with mycophenolate mofetil and corticosteroids in patients suffering from lupus nephritis didn’t meet the project’s primary endpoints. Lupus nephritis is an inflammation of the kidney and a complication of the autoimmune disease systemic lupus erythematosus. The inflammation may result in progressive loss of kidney functions, and in the most severe cases, lupus nephritis can lead to kidney failure.
After completing 52 weeks of study, Biogen Idec stated a preliminary analysis of the safety data didn’t show any new or unexpected safety signals in patients taking Rituxan. Genentech stated it was disappointed that Rituxan did not show a significant benefit in patients with lupus nephritis, but that it would exploit the insights gained from the study to find new approaches to treat the condition.
Biogen Idec initially developed Rituxan, which received U.S. Food and Drug Administration approval in November 1997. It was cleared for the treatment of a particular type of non-Hodgkin’s lymphoma and is co-marketed in the United States with Genentech.
Biogen Idec’s total revenues in 2008 were $4.1 billion with a profit of $783 million. The company markets three major drugs; its development pipeline includes 15 products in Phase 2 clinical trials and beyond. Currently, Biogen Idec has more than 4,200 employees worldwide.
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