- In a slew of late-stage clinical trials, Roche/Genentech's ocrelizumab decreased the rate of annualized relapses by 46% and 47%, compared with Merck's Rebif (interferon beta 1), in patients with relapsing remitting multiple sclerosis (RRMS).
- In addition, the rate of confirmed disability progression (CDP) was 37% and 43% lower in ocrelizumab-treated patients, compared with Rebif. And according to Roche, the investigational product is the first drug ever to show a benefit in primary progressive multiple sclerosis (PPMS), a more rare and difficult to treat version of the disease. About 15% of MS patients have PPMS.
- Assuming ocrelizumab is approved, analysts are expecting billions of dollars in annual sales, with the understanding that it could become the standard-of-care for early treatment of MS.
When Rebif was approved by the FDA in 2002, it was hailed as a miracle drug for patients with MS, who were able to decrease their annual relapse rate (ARR) by roughly one third. Patients with RRMS were willing to trade off ithe inconvenience of injections and side effects, including flu-like symptoms, to gain some control over symptoms.
However, over time, new compounds entered the market providing patients with a long list of treatment options (Copaxone, Aubagio, Lemtrada, Tecfidera, etc.). The reality is that different patients respond differently to various medications and the medications can stop working after a period of time. In addition, many of the MS drugs are injectables, which many patients dislike.
Now along comes ocrelizumab, which has a relatively benign side effect profile, a proven level of efficacy and only requires bi-annual administration via infusion. The results are very positive in patients with RRMS, while patients with primary progressive MS, who have no approved treatment options, also saw improvements in CDP.
Roche is planning to file ocrelizumab in early 2016, and is pegging this drug as a way to diversify its oncology-heavy portfolio.