Dupixent severe asthma results should propel Sanofi, Regeneron drug to billions more in sales

Dupixent, the Sanofi and Regeneron drug already on a blockbuster arc in atopic dermatitis, has returned significant results in patients with severe asthma, another indication that is expected to add billions of dollars more in sales for the partners.

The two reported today that Dupixent met its two primary endpoints in a late-stage, phase 3 trial in patients with uncontrolled, persistent asthma. It reduced the frequency of severe asthma attacks by 46% in the group overall and by 60% to 67% in patients with high levels of eosinophilic cells. The trial involved 1,902 patients, including 1,795 adults and 107 adolescents.

Sanofi said they expect to get their application into the FDA by year-end and Bernstein analyst Ronny Gal said in a report to clients this morning that he expects the drug to come to the market pretty quickly, in perhaps six months. Bernstein is forecasting $2.5 billion in peak sales for the indication.

Leerink analyst Geoffrey Porges put the numbers even higher, at $137 million next year and then growing rapidly to $2.7 billion by 2020 and $4.1 billion by 2022. And that, Porges told clients today, is if it achieves just modest—4% to 5%—penetration in the market for poorly controlled asthma.

Therein lies the big question. The Sanofi and Regeneron team is not the only one gunning for a big piece of that market. GlaxoSmithKline has Nucula and already leads in the market but AstraZeneca and Amgen last week reported out phase 2 data for severe asthma for their first-in-class thymic stromal lymphopoietin antagonist, tezepelumab.

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Analysts said the AstraZeneca drug could be a significant player in a what looks to become a competitive market. Leerink analyst Seamus Fernandez suggests their candidate could get a faster-than-expected approval if the partners are able to persuade the FDA to approve it on the strength of the phase 2b data while they carry out a confirmatory phase 3 trial. The FDA did that with Dupixent.

Bernstein’s Gal noted today that the Sanofi and Regeneron drug should have an easier time getting payers to approve coverage of Dupixent in severe asthma than they have in atopic dermatitis, where pre-approvals are often required. Analysts have pegged peak sales in that indication at about $2.5 billion.

"It is going to be hard for managed care to block this drug since the need with the asthma patient, given this is a progressive disease, unlike atopic dermatitis," Gal said.