Drug for hard-to-treat sclerosis

Ocrelizumab was part of the trial called Oratorio, which was the first study that showed the drug not only can treat the most common form of Mississippi, the relapsing-remitting type, but also a different form known as primary progressive Mississippi (PPMS).

According to Thomson Reuters Cortellis, this figure is significantly higher compared to recent consensus forecasts of around $720 million in 2020.

Switzerland’s Roche has moved into pole position in the race to launch the world’s first treatment for progressive multiple sclerosis but smaller players are working hard on rival approaches.

Chief Executive Severin Schwan had told Reuters in an interview earlier this month that ocrelizumab’s success in relapsing multiple sclerosis already made it a “huge opportunity” and a positive result in PPMS would be “pure upside”.

Biotechnology firm Genentech, a member of the Roche Group, announced on September 27 that its experimental medicine ocrelizumab has been proven to be successful in addressing a hard-to-treat form of multiple sclerosis (MS) during a crucial Phase III study.

The current market for Mississippi drugs is worth around $20 billion a year, derived from the approximately 85 percent of Mississippi patients with relapsing disease.

Multiple sclerosis (MS) is a chronic, progressive neurodegenerative disorder that results from an abnormal attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and damage to the myelin layer that covers and protects neurons, resulting in motor function impairment, irreversible neurological disability and paralysis.

The researchers discovered that the occurrence of adverse events linked to the ocrelizumab treatment was similar to the placebo, with most patients showing mild to moderate reactions related to the infusions.

Genentech is now planning to obtain marketing authorization for ocrelizumab as an approved therapy for both PPMS and relapsing Mississippi, and plans to submit data on the ORATORIO and OPERA I and II trials to the U.S. Food and Drug Administration (FDA) in early 2016.

That makes the success of Roche’s antibody drug ocrelizumab in a 732-patient global clinical trial big news.

Preliminary data from the clinical trial will be presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis on October 10. The group also reported results at the weekend for its new immunotherapy drug atezolizumab in lung and bladder cancer, which may help it win quick regulatory approval.