Roche Holding AG RHHBY announced that two randomized, double-blind, double-dummy, multi-centre phase III studies (OPERA I and OPERA II) evaluating the efficacy and safety of ocrelizumab (600 mg intravenous infusion) have met their primary and major secondary endpoints. Both studies compared ocrelizumab to Merck KGaA MKGAF/Pfizer’s PFE Rebif for the treatment of people suffering from relapsing multiple sclerosis.
The primary endpoint in both studies measured ocrelizumab’s ability to reduce the annualized relapse rate over a period of two years compared to Rebif. Apart from meeting this endpoint, ocrelizumab led to a significant reduction in the progression of clinical disability and the number of lesions in the brain (measured by MRI) compared to Rebif.
Roche intends to submit these data for review to regulatory authorities in the U.S. and EU in the first quarter of 2016.
Meanwhile, the company is conducting additional analyses on OPERA I and OPERA II with detailed data expected to be presented at an upcoming medical congress.
We note that the phase III development program for ocrelizumab includes three studies – OPERA I, OPERA II studies and ORATORIO (a randomized, double-blind, global multi-centre, placebo-controlled study in people with primary progressive multiple sclerosis). Roche intends to announce results from ORATORIO later this year.
We note that the market for multiple sclerosis is already crowded with several drugs including Tecfidera, Tysabri and Gilenya, among others.
Roche carries a Zacks Rank #2 (Buy). Another well-ranked stock in the health care sector is Abbott Laboratories ABT, carrying the same Zacks Rank as Roche.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment