September 28, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO— After a successful phase III clinical trial showing reduced progression of clinical disability, Genentech is planning to seek regulatory approval for its multiple sclerosis treatment ocrelizumab sometime next year, the company announced this morning.
Genentech, a division of Switzerland-based Roche , said its Phase III trial ORATORIO was successful in meeting its primary endpoints in the treatment of two types of multiple sclerosis, relapsing MS, which is the most common form of the disease, and primary progressive MS, a debilitating form of the disease marked by steadily worsening symptoms. There are currently no approved treatments for PPMS, but Genentech is hoping ocrelizumab will be a groundbreaking medication for that subset of patients, which is believed to be about 10 percent of the MS population, Genentech said.
Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. The most common adverse events were mild-to-moderate infusion-related reactions, Genentech said. Ocrelizumab is administered intravenously twice per year.
“Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS,” Sandra Horning, Genentech’s chief medical officer, said in a statement.
Multiple sclerosis is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around the nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage, which can cause a wide range of symptoms, including muscle weakness, fatigue, difficulty seeing, and may eventually lead to disability.
Ocrelizumab is expected to be a new multi-billion dollar treatment for a rarer form of multiple sclerosis. Tim Race of Deutsche Bank told Reuters he estimates the drug to generate annual sales of about $5 billion, much higher than the $720 million by 2020 projected by Thompson Reuters. Roche has not yet suggested a price for the medication. According to a recent report on MS therapeutics by GBI Research, the global market for MS treatments is expected to hit $17.9 billion by 2019. GBI expects a number of new drugs and monoclonal antibodies (mAbs) to hit the market in the next couple years.
About 85 percent of the MS market is made up of patients with the relapsing type of disease.
There are currently a number of treatments on the market, including Teva Neuroscience’s Copaxone, which had global sales in 2012 of $4 billion. Other drugs include Novartis AG ' Gilenya and Biogen, Inc.‘s Tecfidera. Biogen’s drug has received some negative press after Dutch doctors published a report in the “New England Journal of Medicine” saying more cases of brain infections may occur in patients taking drugs similar to the company’s top multiple sclerosis treatment. In their report, the doctors noted that patients who take dimethyl fumarate, which Biogen markets as Tecfidera, are at “risk for opportunistic infections, ” including progress multifocal leukoencephalopathy (PML), which may initially present as new or worsening weakness in the body.
In addition to the news about Ocrelizumab, over the weekend Genentech announced atezolizumab, an investigational immunotherapy medicine, showed positive results in late stage trials shrinking tumors in both bladder cancer and non-small cell lung cancer.“People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease, and there are no approved treatments for this debilitating condition”
