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A drug candidate that Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) jointly developed has beaten AbbVie ’s ( ABBV ) best-selling rheumatoid-arthritis (RA) drug in a late-stage study, the companies said Friday. Regeneron and Sanofi said that their monoclonal antibody sarilumab met the trial’s main goal of improving symptoms after 24 weeks of a biweekly dosing regimen. Some 72% of patients on sarilumab achieved at least a 20% improvement in signs and symptoms based on American College of Rheumatology criteria, in contrast to 58% of the patients in the Humira group. Both groups experienced about the same rate of negative side effects, though the sarilumab group showed a higher rate of neutropenia, or lowering of white blood cells. Humira is currently the top-selling RA drug and, indeed, the top-selling drug of any kind in the world today, but its number of competitors is rising. Last fall baricitinib, a drug that Eli Lilly ( LLY ) and Incyte ( INCY ) co-developed, also beat Humira in a head-to-head trial; unlike the injectable Humira and sarilumab, it is delivered orally. Roche ’s ( RHHBY ) intravenous medicine Actemra has also bested Humira in trials. Regeneron and Sanofi have already applied for FDA approval of sarilumab based on earlier data, with a decision due by Oct. 30. RBC Capital Markets analyst Adnan Butt called the news a “modest positive” but added that investors are still concerned with some nearer-term issues with Regeneron’s stock. Among them is a pilot program to test changes in Medicare Part B , announced this week, that could affect a great deal of the reimbursement for Regeneron’s flagship drug Eylea, and a patent lawsuit that Amgen ( AMGN ) filed over another monoclonal antibody in the Regeneron/Sanofi partnership, Praluent. “All else being equal, beating Humira is certainly better than not beating it, but at least some of the discussed overhangs may need clearing before the pipeline receives more credit,” wrote Butt in a research note. By late morning on the stock market today , AbbVie stock was up almost 3% near 58. Sanofi was up 2% near 41, while Regeneron stock was up a fraction near 381. Scalper1 News
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