Genentech's Ocrelizumab Wows in Late Stages and Eyes $18 Billion MS Market
June 30, 2015
By Mark Terry and Riley McDermid, BioSpace.com Breaking News Staff
South San Francisco, Calif.-based Genentech announced today that its clinical studies of ocrelizumab compared to interferon beta-1a (Rebif) in relapsing multiple sclerosis (MS) met their primary and major secondary endpoints.
Two Phase III studies are being conducted, OPERA I and OPERA II. The primary endpoint of both studies was annualized protocol-defined relapse rate (ARR) at two years. The secondary endpoints focused on time to onset of confirmed disability progression, the total number of T1 Gadolinium-enhancing lesions, and new and/or enlarging T2 hyperintense lesions observed on MRI. The studies enrolled 1,656 patients at 307 sites in 40 countries.
“Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies,” said Sandra Horning, chief medical officer and head of Global Product Development for Genentech in a statement. “Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to U.S. and EU regulatory authorities in the first quarter of 2016.”
This is good news for Genentech and for patients with MS. There has been a spate of bad news in this market recently. In April 2015, Dutch scientists published a case study in The New England Journal of Medicine that described a patient who may have died due to a reaction to a common ingredient in treatments for psoriasis and multiple sclerosis. The drug was Tecfidera, manufactured and marketed by Biogen, Inc.. It’s possible that this was an isolated incident, because the drug was mixed by a compounding pharmacy.
Last week The Myelin Repair Foundation (MRF), a Saratoga, Calif.-based nonprofit that funded MS research and has a history of successful innovative research funding, announced it was closing its doors due to insufficient funding. MRF ran on a shoestring budget of about $5 million annually, but about 92 percent of its revenue came from only 56 donors.
In 2012 MRF announced that a Phase I clinical trial for MS had hits its goals earlier. That study was conducted at Cleveland Clinic and studied the efficacy of a new myelin repair therapeutic pathway with mesenchymal stem cells (MSCs).
Late last year Genzyme Corporation's Bill Sibold, head of the company’s MS unit, indicated the company was actively looking for companies to bolster its MS franchise. Genzyme had reported in September positive interim results from the second year of an extension of its MS drug Lemtrada (alemtuzumab). Lemtrada is sold in Europe, but isn’t yet approved in the U.S. Genzyme also markets another MS drug, Aubagio.
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.
It is currently led by Teva Neuroscience’s Copaxone, which had global sales in 2012 of $4 billion. GBI expects a number of new drugs and monoclonal antibodies (mAbs) to hit the market in the next couple years.
A conference call hosted by financial analysis firm Piper Jaffray earlier this spring found that a specialist in multiple sclerosis believes that she sees continued growth of Biogen Idec, Inc. 's Tecfidera and Plegridy, and aggressive switching of daily Copaxoneto three times a week.
Joshua Schimmer, a biotech analyst with Piper Jaffray, said that for emerging treatments, ocrelizumab (Biogen/Genentech) was the “most exciting in her opinion,” as well as laquinimod (Teva).
“She was less enthusiastic for new S1P targeting drugs or for Lemtrada or daclizumab,” wrote Schimmer in a note to investors. “While BIIB's franchise seems to be increasing in influence, there may be some dilutive effect from its partial-ownership of ocrelizumab.”
There were also some surprises. Schimmer said the specialist had expected cases of progressive multifocal leukoencephalopathy to appear in Tecfidera treated patients. In anticipation of this, she began monitoring bloodwork every three months, even more regularly than recommended—which meant the overall impact to prescribing Tecfidera “is expected to be minimal.”
“The utility of lymphocyte assessment to gauge risk of PML with Tysabri was seen as differentiated versus Gilenya, for which most patients experience lymphopenia and as such identifying high-risk populations is more challenging,” wrote Schimmer.
Still, ocrelizumab And laquinimod were seen as promising. “The specialist was most excited about ocrelizumab, the fully humanized CD20 antibody in development by BIIB/Roche, and if Phase II data is replicated in Phase III, she expects to use it in 15 to 20 percent or more of patients, taking share from all other therapies."
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That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.