Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus (RSV) antibody clesrovimab, Sanofi—which last year won its own nod for its AstraZeneca-partnered RSV preventive Beyfortus—isn’t breaking a sweat.
“We really welcome that there are more players to come because it increases the size of the playing field,” Thomas Triomphe, Sanofi’s executive vice president for vaccines, said of the looming RSV competition on an analyst call Friday.
Triomphe noted that Merck still has more data to show on clesrovimab after unwrapping phase 2b/3 results last week. In the meantime, Sanofi remains “very confident” in the Beyfortus readouts it’s published thus far, he said.
Speaking to the data on protection afforded by Beyfortus through six months, “what’s very nice about these data is that there is no waning efficacy,” Triomphe pointed out.
“After six months, we still see 83% efficacy against hospitalization," he said, adding that he believes “duration of protection is significantly in favor of Beyfortus compared to clesrovimab.”
In Merck’s infant RSV study, clesrovimab managed to cut RSV-related hospitalizations and RSV-related lower respiratory infection hospitalizations by 84% and 91%, respectively, versus placebo through five months.
On the trial’s primary endpoint, clesrovimab reduced the incidence of RSV-associated medically attended lower respiratory infections by 60% versus placebo.
Caveating against the inherent uncertainties of cross-trial comparisons, Sanofi Chief Financial Officer François-Xavier Roger pointed out on Friday’s call that the available Beyfortus data have shown higher efficacy of about 75% reduction in incidence of medically attended lower respiratory tract infection versus clesrovimab’s 60%.
And, regardless of whether Merck enters the 2025-2026 RSV season with clesrovimab as planned, “2025 will be a year of growth for Beyfortus,” the CFO stressed.
Since its approval last July, Beyfortus has gradually built up its sales profile.
In 2024’s third quarter, the preventive antibody logged sales of 645 million euros ($699), marking a staggering 382% increase over the same period in 2023. Overall, the drug is nearing the blockbuster threshold with 845 million euros in sales since the start of the year.
Shortly after last year’s launch, Beyfortus quickly ran into supply constraints thanks to “higher than anticipated demand,” Sanofi said at the time.
Sanofi and its partner AZ have moved quickly to ensure there isn’t a supply crunch repeat in 2024, recently adding a new filling line and shipping doses of the antibody early to get ahead of 2024’s RSV season.
“With 20 markets, we don’t see any capacity limitation,” Triomphe said on Sanofi’s call. “We’ll grow that supply for next year and the year after to make sure that there will be, again, no supply constraints.”
The Sanofi execs’ Beyfortus comments came as the French pharma reported 15.7% sales growth in the third quarter.
The company’s immunology stalwart Dupixent continued to deliver, bringing home sales of nearly 3.5 billion euros (around $3.8 billion), marking a roughly 24% increase over 2023’s third quarter. Sanofi confirmed its full-year sales target for Dupixent of roughly 13 billion euros.
Elsewhere, new pharma launches grew 67.1% to 727 million euros ($787), with hemophilia med Altuviiio, Pompe disease treatment Nexviazyme and Rezurock for graft-versus-host disease leading the charge.
Meanwhile, Sanofi saw revenues for its consumer health arm, Opella, grow 7.9%.
Earlier this week, Sanofi confirmed it had entered exclusive negotiations with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business, which is valued at around 16 billion euros.