Sanofi, Regeneron's Dupixent shows promise as 'smoker's lung' drug

Sanofi's asthma and eczema drug Dupixent met all targets in a trial to treat "smoker's lung", giving a major boost to the French drugmaker's growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron, led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline.

Sanofi and Regeneron said in a statement on Thursday the Phase III trial with 939 current or former smokers as participants also showed improvements in lung function, quality of life and COPD respiratory symptoms. "COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade," said Regeneron Chief Scientific Officer George Yancopoulos.

Sanofi added its "bold" decision to go without earlier-stage clinical COPD trials had shaved years off the development time. Sanofi previously forecast Dupixent would generate up to 13 billion euros ($14.2 billion) in sales in its best year as it seeks to widen its use across several inflammatory conditions.

Investors had expected even more, on average, partly on hopes the injection will also qualify as a COPD treatment, a common disease that the company has so far excluded from its sales target. Sanofi said it was too early to update its sales estimate for the product.

The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19%, of the French group's overall sales of 43 billion euros last year. That was a currency-adjusted increase of 44% from a year earlier. Sanofi reports combined global Dupixent sales from its alliance with Regeneron.

The companies said that full efficacy and safety results would be presented later. Overall rates of adverse events were 77% for Dupixent and 76% for placebo.

The companies on Tuesday announced the European Commission (EC) had approved Dupixent in the European Union to treat severe atopic dermatitis in children aged six months to five years old who are candidates for systemic therapy. Dupixent was also approved by the EC to treat eosinophilic esophagitis, a condition that damages the esophagus, in January.

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