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Print Edition StoriesTuesday, March 9, 2010
Biogen, Roche halt arthritis drug trial
By Ron Leuty, San Francisco Business Times
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Drug developers Biogen Idec and Roche have spiked a late-stage rheumatoid arthritis drug trial amid concerns by a review panel that the treatment may in rare cases cause fatal infections.
The move is the second hit for ocrelizumab, a drug that the companies were testing for rheumatoid arthritis and lupus. The lupus part of the trial already had been halted due to “serious and opportunistic infection signals.”
Roche, which is the parent company of South San Francisco-based Genentech, and Cambridge-based Biogen Idec (NASDAQ: BIIB) did not say what type of infections patients developed and how many patients died from the infections.
Ocrelizumab had been pegged as a potential $1 billion to $2 billion drug, according to Dow Jones news service, focused on patients with rheumatoid arthritis, lupus and multiple sclerosis.
The companies said they will conducted a detailed analysis of the data from multiple trials of ocrelizumab to help determine the future of the program.
“Patient safety is of the utmost importance in all of our drug development programs,” said Dr. Hal Barron, Roche’s chief medical officer.
The companies in December said a Phase 3 trial of ocrelizumab showed that the humanized monoclonal antibody, which manipulates the body’s immune system, improved the signs and symptoms of rheumatoid arthritis. At the time, the companies said a higher percentage of serious infections occurred in patients receiving ocrelizumab versus those on a placebo.
Another trial of ocrelizumab in rheumatoid arthritis patients was placed on clinical hold by the companies in December.
The drug remains in Phase 2 trials for patients with relapsing-remitting multiple sclerosis.
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