Roche’s Top Drug’s New High-Dose Version Fails in Study

(Bloomberg) — Roche Holding AG said a high-dose version of Ocrevus, its best-selling multiple sclerosis drug, failed to outperform the original in a large study, potentially reducing the drugmaker’s ability to fend off cheaper copies. 

Doubling or tripling the dose over 120 weeks of treatment didn’t slow progression of the disease any more than the current version of the drug, Roche said on Wednesday. The findings affirm that the existing dose is optimal, said Levi Garraway, Roche’s chief medical officer. 

The results are a blow to the company’s strategy for extending the profitable life of the MS drug, which analysts anticipate will rake in 7.32 billion Swiss francs ($8.27 billion) in sales this year. Roche had told investors in January that the high-dose version of Ocrevus had the potential to be the new standard treatment for MS, a chronic and potentially debilitating neurological disease that can bring on muscular weakness and numbness and render walking difficult. 

Roche shares fell 2.9% in early trading Thursday. The stock has risen about 27% in the 12 months through Wednesday’s close as confidence in Roche’s drug pipeline started to improve among investors. Shares of rival TG Therapeutics, which also has a drug for MS, closed up 5.5% on Wednesday. 

Roche has also been trying to reach new patients for Ocrevus, with a version of the drug that can be given via a shot instead of needing to be infused in a doctor’s office. The shot should be able to add about 2 billion francs in annual sales, Roche’s pharmaceutical unit chief, Teresa Graham, said in January. The company said it’s also developing a new high-concentration formula of Ocrevus that could also help make treatment more convenient for patients. 

Roche declined to comment on when the original version of Ocrevus is likely to face patent expiry and cheaper copies. But biosimilar makers are already gearing up to compete. Amgen Inc. said this year it’s testing a copy of Ocrevus in patients, while Celltrion Inc. has also registered a competitor study in Europe.

Begun in 2020, Roche’s failed high-dose study followed more than 800 patients with relapsing MS, the most common form of the disease. Still to come this year are results from another large study of high-dose Ocrevus in patients with primary progressive MS, a less common and generally more disabling version of the disease that has fewer options for treatment. 

(Updates with shares in fourth paragraph.)

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