Swiss drugmaker Roche on Friday won a key European panel’s recommendation for its multiple sclerosis drug Ocrevus, which is on track for nearly $1 billion in sales in 2017 after winning U.S. regulators’ go-ahead earlier this year.
Ocrevus got a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).
Final approval falls to the European Commission, but it generally follows the CHMP recommendation.
Ocrevus, which racked up sales of 500 million Swiss francs ($503 million) in the first nine months of 2017, is seen generating revenue of more than $4 billion a year by 2022, according to a Reuters survey of analyst estimates.
Roche’s drug is pivotal to the Basel-based drugmaker’s strategy of bringing new drugs to market to replace older medicines whose sales are declining now that they are going off-patent.
“We are pleased that the CHMP has recognized the clinical significance of the Ocrevus data, particularly for people living with primary progressive MS … that currently has no approved treatments in Europe,” said Sandra Horning, Roche’s chief medical officer.
Roche’s trio of Herceptin, Avastin and MabThera account for more than $20 billion in annual sales, but competition from cheaper biosimilar copies has already begun eroding sales of some of the medicines.
For rival Biogen, which co-developed Ocrevus, Roche’s drug is a double-edged sword.
Roche must pay its U.S. partner a royalty of up to 24 percent on Ocrevus’s U.S. sales and a 3 percent royalty on sales outside the United States. But Ocrevus is seen eating significantly into Biogen’s Tecfidera MS drug, which had nearly $4 billion in annual sales in 2016.
Ocrevus’s continued headway with European regulators is particularly important, given other drugs in Roche’s pipeline have had mixed results in recent months.
In September, a pair of promising medicines, Zelboraf against advanced skin cancer and lampalizumab against vision loss, failed in late-stage trials.
And while Roche’s Tecentriq immunotherapy won EU approval in September for advanced lung and bladder cancer, it failed in a study against bladder cancer compared to chemotherapy earlier this year and has since lost market share.
Roche Chief Executive Severin Schwan has stuck to expectations his company’s sales will continue to grow on the strength of new medicines like Ocrevus.