Sanofi and Regeneron reveal data on ‘blow-out’ drugs for smokers’ lungs
Alexandra Ross

March 23, 2023

The drug met the primary and all secondary objectives in the COPD study

The previous peak sales estimate of €13 billion was made excluding COPD

The drug could be the first new COPD treatment in over a decade

March 23 (Reuters) – Sanofis (SASY.PA) asthma drug Dupixent has met all targets in a study aimed at treating ‘smoker’s lung’, potentially boosting the French drugmaker’s growth prospects by billions but also increasing its heavy reliance on its best-selling drug underlines.

In a late-stage study, Dupixent, co-developed with Regeneron (REGN.O), resulted in a 30 percent reduction in moderate to severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially fatal disease characterized by a progressive decrease in lung function is marked.

Shares of Sanofi and Regeneron rose after they said in a joint statement on Thursday that a Phase III study of 939 current or former smokers also showed improvements in lung function, quality of life and respiratory symptoms.

The French group’s stock rose 5.2% by 1205 GMT, hitting a seven-month high and far outperforming the barely changed STOXX Europe 600 Health Care Index (.SXDP).

Regeneron is up 8.6% in U.S. premarket trading and was expected to open at a record high.

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“COPD is an urgent global public health concern and, due to its heterogeneity, a notoriously difficult-to-treat disease for which no novel treatments have been approved for more than a decade,” said George Yancopoulos, Regeneron’s Chief Scientific Officer.

Sanofi added that its “bold” decision to forgo earlier-stage COPD clinical trials has cut development time by years.

JP Morgan analyst Richard Vosser said the test update provides “blow-out data” for investors and that the market consensus for Dupixent’s €15.7 billion in 2027 sales is likely up €1-2 billion will be increased.

“We see Dupixent’s data on COPD exceeding all market expectations for utility,” said the analyst.

Jefferies analysts said the update had “perhaps the best efficacy” for treating the disease.

Sanofi previously forecast that Dupixent would post sales of up to 13 billion euros ($14.2 billion) in its best year as it seeks to expand its use into several inflammatory diseases, but it has excluded COPD from its revenue target .

Sanofi said Thursday it was too early to update its sales estimate for the product, which is also used to relieve eczema.

The anti-inflammatory drug accounted for €8.3 billion last year, or more than 19% of the French group’s total sales of €43 billion. That was a currency-neutral increase of 44% over the prior year.

Sanofi announces combined global sales of Dupixent from its alliance with Regeneron.

The companies said full efficacy and safety results would be presented later. They added that a second late-stage COPD Dupixent study is underway, with the first data read expected next year.

The overall adverse event rates in the study reporting results were 77% for Dupixent and 76% for placebo.

Shares of Sanofi took a hit after disappointing study results in August 2022 with a once-promising drug candidate for breast cancer.

Legal claims that heartburn drug Zantac causes cancer have also weighed on the stock.

The group, led by UK CEO Paul Hudson, this month entered into an agreement to acquire Provention Bio Inc (PRVB.O) for $2.9 billion to continue its work on a US-approved type 1 diabetes therapy – Boost therapy.

Analysts have said that the expected market debut of two new products this year to offset dependence on Dupixent would be a major test of the company’s marketing and development prowess and a chance to regain investor confidence.

These products are Altuviiio, for hemophilia A treatment, which requires fewer injections than standard therapy, and Beyfortus, from a partnership with AstraZeneca (AZN.L), which is a prophylactic injection for the common RSV respiratory infection in infants.

Sanofi and Regeneron announced Tuesday that the European Commission has approved Dupixent for the treatment of severe atopic dermatitis in young children. The drug was also previously approved in Europe to treat a type of esophagitis.

($1 = 0.9168 euros)

Reporting by Ludwig Burger in Frankfurt and Juby Babu in Bengaluru; Editing by Mark Potter and Jason Neely

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