The newest multiple sclerosis drug could be a boon for patients — and a threat to the multibillion-dollar business of Biogen Inc., the leading seller of MS treatments.
When regulators in March cleared the new drug, called Ocrevus and made by Genentech, it was the latest in a line of more than a dozen medicines that have emerged over the past two decades to treat MS. The neurological disease afflicts at least 400,000 Americans and more than 2.3 million people worldwide.
But Ocrevus was the first drug approved for patients with primary progressive MS, the most severe form of the disease. It has also proved effective against relapsing forms of MS, the most common type of the disease and the one targeted by other drugs that are already available.
“This is a great market disrupter,” Dr. Darin T. Okuda, a neurologist and MS expert at the University of Texas Southwestern Medical Center in Dallas, told investors last week on a conference call hosted by the investment bank Mizuho Securities USA. He said he planned to switch MS patients to Ocrevus from other drugs, including Biogen’s Tysabri.
While it’s too early to project Ocrevus sales, there’s little doubt it could pose a tough challenge for Cambridge-based Biogen.
In the less than six weeks since the Food and Drug Administration approved Ocrevus, “we’re seeing a lot of prescriptions across the board,” said Hideki Garren, group medical director for Ocrevus at California-based Genentech. “There’s quite a lot of interest, quite a lot of buzz.”
Genentech, owned by the Swiss drug giant Roche, is not expected to disclose its initial Ocrevus sales until later in the year. But competitors are paying close attention.
Biogen sold $8.8 billion worth of MS drugs last year, led by a trio of so-called blockbuster medicines — Tecfidera, Avonex, and Tysabri — that each rang up more than $1 billion in sales while targeting different subsets of patients. The franchise accounted for the bulk of the company’s $11.4 billion in 2016 revenue, and Biogen is counting on it to remain an anchor as the company pursues a risky transition strategy: developing Alzheimer’s disease treatments.
Ocrevus, ironically, emerged from a collaborative research program between Genentech and Biogen. But in 2010, the parties amended their agreement and Genentech took over the program, promising Biogen royalties on future sales of the experimental drug.
In clinical trials, Ocrevus showed benefits in treating all types of MS and outperformed a comparison drug already approved, Rebif, sold by EMD Serono of Rockland. Patients taking Ocrevus had lower relapse rates and slower MS progression than those on Rebif in a pair of studies. Genentech also priced Ocrevus at $65,000 a year, substantially less than other MS drugs on the market.
While Biogen will receive royalties amounting to more than 20 percent of Ocrevus sales, analysts have projected they will be more than offset by the eventual erosion of sales and profitability from Biogen’s other top-selling drugs as Ocrevus grows in popularity.
Genentech didn’t test Ocrevus in a head-to-head comparison with Tysabri or any other Biogen drug. Nonetheless, because of the new drug’s potency and performance in clinical studies, Biogen “stands to lose revenue, and profits, in relapsing-remitting MS from cannibalization of its existing products,” biotech analyst Geoffrey Porges at Leerink Partners, a Boston health care investment bank, wrote in a note to investors shortly after Ocrevus was approved.
Matt Fearer, a spokesman for Biogen, said the company’s current portfolio of drugs, which work in different ways, offers options to a broad range of MS patients.
“We would expect Ocrevus to have some impact on our MS business,” Fearer said in a statement. “While we are closely monitoring the Ocrevus launch, as we do with all new treatments, our primary focus remains our commitment to serving the MS community and the patients living with this disease.”
Ocrevus is a type of biotech drug called a monoclonal antibody and works against certain immune cells associated with nerve cell damage. Unlike earlier MS drugs, however, Ocrevus works by binding to surface proteins expressed on a part of the immune system known as B cells.
“We target the B cells because our research shows the B cells are central in the pathology of multiple sclerosis,” Garren said.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.