REGN

By Colin Kellaher

Shares of Regeneron Pharmaceuticals Inc. rose sharply in premarket trading Thursday after the biotechnology company and partner Sanofi SA reported positive late-stage study data for their blockbuster anti-inflammatory drug Dupixent in chronic obstructive pulmonary disease, or COPD.

Regeneron and Sanofi said Dupixent met the primary and all key secondary endpoints in the first of a pair of Phase 3 studies in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of Type 2 inflammation.

The companies said Dupixent is the first and only biologic to show a clinically meaningful and highly significant reduction in moderate or severe acute exacerbations of COPD over 52 weeks, while also showing significant improvements in lung function, quality of life and COPD respiratory symptoms.

There are currently no biologics to treat COPD, which afflicts smokers, and other antibodies have failed to deliver conclusive results.

Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the product internationally.

Dupixent generated roughly $9 billion in sales last year, and Guggenheim analyst Yatin Suneja recently said success in Type 2 COPD could mean a $3 billion annual market opportunity for Dupixent.

Regeneron and Sanofi said their second, Phase 3 trial of Dupixent in COPD is ongoing, with data expected next year.

Regeneron shares, which closed Wednesday at $751.30, were recently up 5.9% to $795.90 in premarket trading, while Sanofi shares rallied 5% in Europe.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 23, 2023 07:14 ET (11:14 GMT)

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