Roche (RHHBY) and Biogen Idec (BIIB) announced Monday that they were suspending the development of Ocrelizumab for the treatment of rheumatoid arthritis following serious adverse events, including deaths, of patients in studies of the drug. They are putting the program on hold and will evaluate it before proceeding any further.
An independent safety monitoring board recommended the pharmaceutical firms halt the program after concluding that the safety risks outweighed the benefits observed in some patients. Specifically, the board detected "serious and opportunistic infections, some of which were fatal."
"Patient safety is of the utmost importance in all of our drug development programmes," Hal Barron, chief medical officer at Roche said in a statement. All drugs have side effects, which are generally discerned during their development; depending on the balance of risks versus benefits, a drug may be approved -- or not.
Ocrelizumab Is Under Consideration for Several Autoimmune Diseases
Ocrelizumab -- a drug co-developed by Roche and Biogen Idec -- is similar to Rituximab, which is one of Roche acquisition Genentech's greater successes. Rituximab is used to treat cancer and rheumatoid arthritis. Like Rituximab, Ocrelizumab also selectively targets cells with only certain markers, thus interferring with the inflammation in rheumatoid arthritis and inhibiting the series of reactions that lead to the symptoms and irreversible joint damage experienced by people with the condition.
Rheumatoid arthritis is an autoimmune disease characterized by painful inflammation of the joints that can lead to deformity and disability. More than 20 million people worldwide, and twice as many women as men, suffer from rheumatoid arthritis.
The Ocrelizumab program has known several ups and downs. Just a few months ago in December, the companies said a late-stage trial in rheumatoid arthritis patients showed it significantly reduced the signs and symptoms of rheumatoid arthritis. But the company also previously announced that a different rheumatoid arthritis clinical study had been put on hold following an risk-benefit assessment.
Next Steps Are Yet to Be Determined
Other than rheumatoid arthritis, Ocrelizumab has been tested as a treatment for lupus and relapsing-remitting multiple sclerosis with varying degrees of success. In December, the companies said in a Phase II trial in multiple sclerosis patients, Ocrelizumab showed a strong effect, with a reduction in signs of disease activity. But a study in lupus nephritis patients was previously halted due to similar risks announced Monday. The Phase 2 study of Ocrelizumab in relapsing-remitting multiple sclerosis is ongoing.
Roche says the companies will now conduct a detailed analysis of all the data to determine the future of the Ocrelizumab rheumatoid arthritis clinical program. The drug would have had peak sales potential of $935 million to $1.87 billion in all three uses, according to analysts. But given the FDA's recent focus on safety, a few analysts now doubt the development of this drug will continue -- for any condition. While study halts of this type aren't that uncommon, this is still a setback for Roche, its investors and hopeful patients.
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