Genentech, a member of the Roche Group, was founded more than 35 years ago and has been focused on a variety of research fields, including cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases.
Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous system, including multiple sclerosis (MS), Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS).
Genentech’s Ocrevus (ocrelizumab) is a humanized monoclonal antibody that selectively targets CD20-positive B cells, a type of immune cells thought to be critical for the damage inflicted in myelin and nerve cells, and in the initiation of a series of immune reactions that lead to disability in people with MS.
Ocrevus recently became the first investigational medicine to be granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for patients with primary progressive MS (PPMS). With no approved treatments for PPMS, ocrelizumab may have the potential to address an important unmet medical need.
The Breakthrough Therapy Designation, meant to expedite ocrelizumab development and review, has been based on results from the ORATORIO Phase 3 trial, a global multicenter study evaluating the efficacy and safety of ocrelizumab compared to placebo in 732 PPMS patients. The trial showed reduced disability progression, reduced brain atrophy, and other markers of disease activity for patients taking ocrelizumab compared with the placebo group.
Genentech is not only trying to obtain marketing authorization for ocrelizumab for PPMS patients, but also for patients with relapsing MS, based on data from two other pivotal Phase 3 studies, OPERA I and OPERA II.
The OPERA trials, two Phase 3 trials that addressed ocrelizumab efficacy compared to interferon beta-1a (Rebif) in patients with relapsing forms of MS, reported positive outcomes for Genentech’s compound. Ocrelizumab decreased the annual relapse rate by almost 50 percent, reduced disability progression, and decreased the number of lesions in the brain. Additionally, half of the patients on ocrelizumab therapy had no evidence of relapses, no confirmed disease progression, or no new or enlarging lesions, compared to 25 to 30 percent of patients on Rebif.
Genentech was one of the pharmaceutical companies present at the June 1-4 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in National Harbor, Maryland.
At the meeting, Multiple Sclerosis News Today interviewed Dr. Peter Chin, a renowned neurologist and principal medical director of Global Neuroscience Development at Genentech, who discussed the effectiveness and safety of ocrelizumab, the importance of targeting B-cells in MS, and future plans for the drug.
Here is the video of our interview:
Chin emphasized that in the OPERA trials in relapsing MS, researchers observed a “40 percent reduction in disability progression compared to interferon beta-1a — so, a very important and meaningful result.”
Concerning approval of the drug, Chin said, “We are working very diligently, as hard as we can, to fill the application for marketing authorization in the first half of this year, and are very committed to, hopefully, securing approval as fast as possible, recognizing the high degree of unmet medical need.”