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Monday, March 8, 2010

Infections and deaths force Biogen, Roche to suspend blockbuster program

By John Carroll

In a significant setback, Biogen Idec and Roche have suspended the troubled development program of ocrelizumab for rheumatoid arthritis, and analysts are already questioning if work related to multiple sclerosis may soon follow.

The companies made their move after an independent safety board said that the risks outweighed the potential benefit from the experimental therapy, noting that serious and opportunistic infections had afflicted patients taking the therapy, some of whom died. Safety concerns had already forced researchers to halt two clinical trials for rheumatoid arthritis and lupus.

"The news wasn't completely unexpected since some trials were on hold before," notes Birgit Kulhoff, an analyst at Rahn & Bodmer. "However, with the obvious fatalities the drug has a high likelihood of not being approvable.. I would expect that the MS trials will be stopped as well."

"Patient safety is of the utmost importance in all of our drug development programs," says Roche's Chief Medical Officer Hal Barron. Kulhoff had projected blockbuster sales if the drug had gone on to an approval for all three indications.

- see the companies' release
- here's the MarketWatch report
- here's the story from Bloomberg

Related Article:
Roche's RA drug posts blockbuster results in Phase III
Arbitrator sides with Biogen in Rituxan dispute
Roche/Genentech - Biotech Market Share Report

Read more about: ocrelizumab, Roche, Biogen Idec

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