Biotechnology firm Genentech, a member of the Roche Group, announced on Sept. 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 clinical study, known as ORATORIO, revealed that ocrelizumab-based treatment has significantly reduced the effects of primary progressive multiple sclerosis (PPMS) on patients. The new drug was able to retard the development of clinical disability sustained by individuals for at least 12 weeks compared with a placebo treatment, based on the Expanded Disability Status Scale (EDSS).
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.
The ocrelizumab treatment and the placebo also showed similar occurrence of serious adverse events, including severe infections.
Genentech's head of Global Product Development and chief medical officer Dr. Sandra Horning explained that patients suffering from primary progressive type of multiple sclerosis often show symptoms that steadily worsen following the onset of the disease, and treatments capable of addressing the debilitating condition have yet to be approved.
Horning said that the ocrelizumab medication is the first of its kind to show a statistically significant and clinically meaningful effect on the development of the disease in patients with PPMS.
The positive results of ocrelizumab treatment in people with primary progressive multiple sclerosis and those suffering from relapsing types of the condition support the hypothesis that B cells are indeed a key component of the disease's biology.
The findings of the ORATORIO study are set to be presented at the upcoming meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on Oct. 10 in Barcelona, Spain.
Tim Race of Deutsche Bank said that the success of ocrelizumab in treating PPMS suggests that the experimental drug could provide Roche with annual sales of approximately $5 billion
According to Thomson Reuters Cortellis, this figure is significantly higher compared to recent consensus forecasts of around $720 million in 2020.
Earlier this month, Roche CEO Severin Schwan said that the success of ocrelizumab in relapsing MS has already made it a significant opportunity for the company and a positive finding in primary progressive multiple sclerosis would be "pure upside".
The Swiss drug manufacturer is now planning to seek regulatory approval for both relapsing multiple sclerosis and primary progressive multiple sclerosis in 2016. This would mean that ocrelizumab could be made available a year later.
Photo: JE Theriot | Flickr
