Ph2 Roche study delivers promising long-term ocrelizumab data on MS

Roche posted positive long-term Phase II numbers for its MS drug ocrelizumab, winning kudos for success outside of the cancer field. But analysts were quick to deduct points on the promising therapeutic as rivals in the field beat it to the blockbuster market.

Overall, Roche reported, "67.3% patients in the ocrelizumab 600mg group and 76.4% of patients in the ocrelizumab 1000mg group had no relapses and no confirmed EDSS progression from week 0-96 ('clinical disease activity free'); 78.2% and 80.0% of patients, respectively, were relapse-free." The data boosted Roche's case for long-term safety and efficacy, giving it a decent shot at an approval in 2014 if Phase III data back it up.  

"This demonstration of long-term efficacy of ocrelizumab confirms the compelling benefit demonstrated in the first 24-week treatment period," said Hal Barron, Roche's chief medical officer. "These results indicate a high likelihood of success of the ongoing [late stage] program."

"The data are promising," said Helvea's Karl-Heinz Koch, according to a report from Dow Jones."But in spite of the strong efficacy and safety data, ocrelizumab is rather late to the game and hence for the time being we forecast limited peak sales of CHF500 million." Novartis's Gilenya is already on the market with Teva in the heated competition to add new drugs.

- here's the Roche release
- check out the Dow Jones report

Special Report: Ocrelizumab - Top 10 Phase III Failures