Ocrelizumab - Top 10 Phase III Failures
The drug: Ocrelizumab
The disease: Rheumatoid arthritis
The company: Roche
At the end of 2009, ocrelizumab looked every inch of a blockbuster for rheumatoid arthritis. The drug hit its primary endpoint in a Phase III, and the therapy appeared poised to set out on a short hike to the FDA.
What a difference a few months can make. First the program was halted after researchers found that patients taking the drug had died, and then they dumped the RA program altogether in May after determining that the therapy's risk/benefit profile couldn't pass muster at the regulatory agencies.
For Roche, the unexpected setback marked a rare failure for its pipeline program. The four late-stage trials in RA were supposed to pave the way to an approval that would generate $2 billion a year in sales. And Roche would have a successor to its blockbuster Rituxan.
Researchers didn't close the curtain entirely on ocrelizumab, though. Roche continued a mid-stage multiple sclerosis trial for the drug, where the appetite for risk is distinctly larger for drugs that can effectively treat the ailment. And just days ago Roche and its partner Biogen Idec were rewarded with some positive new data, but the trial was marred by the death of one patient.