Sanofi (SAN) and Regeneron Pharmaceuticals Inc. (REGN)’s experimental rheumatoid arthritis drug eased symptoms and damage caused by the disease in a clinical trial, advancing its prospects in a market of new anti-inflammatory therapies led by Roche Holding AG. (ROG)
In a study of 1,200 patients for whom the standard treatment methotrexate was not sufficient, sarilumab plus methotrexate eased pain and stiffness twice as much as those who got methotrexate alone, and slowed joint destruction 90 percent more, the two companies said in a joint statement today.
The trial is one of two that Paris-based Sanofi plans to use to seek regulatory approval for sarilumab. The drug may generate sales of 579 million euros ($780 million) by 2020, according to the average of four analyst estimates compiled by Bloomberg. It would compete with Roche’s Actemra and other experimental treatments in development by AbbVie Inc., Johnson & Johnson (JNJ) and Bristol-Myers Squibb Co.
The study evaluated three groups of patients who received, in combination with methotrexate, either a 200 milligram or 150 milligram dose of sarilumab, or placebo. Among those in the study receiving the highest dose of sarilumab, 14 percent withdrew from the trial because of side effects, compared with 5 percent of those on methotrexate alone. Infections were also more common among those on Sanofi’s drug.
The results were from the last of three stages of human tests generally required for regulatory approval.
Rheumatoid arthritis causes inflammation of the joints, often in the hands and feet. It is thought to be caused by problems with the immune system, according to the U.S. Centers for Disease Control and Prevention in Atlanta. About 1.5 million people in the U.S. have it, according to the Arthritis Foundation.
Patients typically start treatment with methotrexate, a cheaply available generic drug. If methotrexate doesn’t work or becomes less effective, doctors can add a therapy such as AbbVie’s best-selling drug Humira or Pfizer Inc.’s Enbrel. There’s no cure for the chronic disease.
Sanofi gained sarilumab as part of an alliance with the Tarrytown, New York-based biotechnology company Regeneron, in which it owns a 17 percent stake.
The drug targets a messenger protein called interleukin-6, or IL-6, that is over-produced by people with rheumatoid arthritis, contributing to joint damage and inflammation.
Basel, Switzerland-based Roche’s Actemra generated $898 million in sales last year. AbbVie is developing a drug that targets IL-6, called ALX-0061, which it licensed from Ghent, Belgium-based Ablynx NV in September in a deal worth as much as $840 million. Johnson & Johnson’s drug is called sirukumab and Bristol-Myers’ is called clazakizumab.
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