After hitting a home run with trial results for Dupixent in chronic obstructive pulmonary disease (COPD), Sanofi and Regeneron are circling the bases, considering an exciting future with another lucrative indication.
What would it mean for the top lines of the companies if Dupixent becomes the first significant treatment advance for COPD in more than a decade and the first biologic approved for the elusive condition?
Analysts at Evercore ISI believe a label expansion to treat COPD would add $2.5 billion in peak sales for Dupixent in the U.S. and another $1 billion outside of the U.S.
The market that awaits for Dupixent in the U.S. is 300,000 patients. Evercore’s figures are based on 30% uptake for Dupixent.
The added revenue would catapult Dupixent beyond the $20 billion mark in annual sales by late this decade, Evercore analyst Josh Schimmer wrote in a note to clients. That would put Dupixent in rarefied air with AbbVie’s immunology superstar Humira and Merck’s cancer mega-blockbuster Keytruda.
The optimism comes from dazzling trial results. In a study of 939 active or former smokers with COPD who were on inhaled standard-of-care treatment, Dupixent showed a clinically significant 30% reduction in moderate or severe exacerbations over 52 weeks.
It also met all secondary endpoints, showing improvements in lung function, quality of life and respiratory symptoms.
“Dupixent’s results were unambiguously strong, hitting meaningfully on all key measures,” Schimmer wrote in the note. “This kind of profile should drive meaningful commercial adoption.”
Analysts from Jefferies added that that data were “perhaps best case efficacy.”
The companies took a major gamble, moving directly into late-stage trials instead of starting small and working up progressively.
“This was a high-risk study,” Morgan Stanley analyst Mark Purcell wrote. “With the strength of the data, peak penetration could be higher than we previously expected.”
A second replicate study is underway for Dupixent in COPD patients, which will read out in 2024. It’s not certain whether a potential approval would hinge on results of that study. The companies did not say when they would submit an approval request.
Dupixent, which was greenlighted for eczema in 2017 and for asthma the following year, is already on a juggernaut trajectory, generating $8.7 billion in sales last year, which was a 40% increase from 2021.