Once tapped as a likely blockbuster, Roche and Biogen Idec have opted to kill their ambitious late-stage development program of ocrelizumab as a treatment for rheumatoid arthritis. Researchers had already been forced to halt trial work earlier this year after patients taking the drug died during the study. And an earlier trial for lupus had already been halted on safety concerns. Once the companies concluded that the anti-inflammatory drug's risk profile fell short of their competitors' therapies, the program was doomed.
The move to end the arthritis work is a setback for Roche, which had been hoping to see ocrelizumab go on to extend the franchise it had created with Rituxan. The two therapies are similar, but Rituxan will lose patent protection in about four years. And analysts had estimated that ocrelizumab, once in four late-stage arthritis trials, had the potential to earn more than $2 billion a year.
Just last December researchers noted that the first of the Phase III studies had hit its primary endpoint, putting the developers on track to a 2010 filing. But even then an analysis had flagged a higher rate of infections among the group taking ocrelizumab--a molecule that targets CD20 positive B cells.
A Phase II trial of ocrelizumab will continue for multiple sclerosis, a field where patients have a higher tolerance for risk. And the end of a single-star development program isn't likely to do any significant damage to Roche, which gets star marks for a deep pipeline of great prospects.
- check out Roche's press release
- here's the story from the Wall Street Journal (sub. req.)