Sanofi, Regeneron’s Drug Succeeds in High-Stakes Lung Trial

Sanofi’s prescription drug Dupixent helped patients with a chronic lung disorder breathe better and regain lung function, opening a new avenue of growth for the blockbuster medicine.

(Bloomberg) — Sanofi’s prescription drug Dupixent helped patients with a chronic lung disorder breathe better and regain lung function, opening a new avenue of growth for the blockbuster medicine. 

The asthma injection showed promising results in a final-stage study of almost 1,000 current or former smokers with chronic obstructive pulmonary disease, an ailment in which no new treatment approach has succeeded in more than a decade, Sanofi said Thursday. 

The medicine developed with Regeneron Pharmaceuticals Inc. succeeded where others have failed, including AstraZeneca Plc’s Fasenra and GSK Plc’s Nucala, Peter Welford of Jefferies wrote in a recent note. 

Sanofi shares surged as much as 5.4% in Paris trading, their biggest gain this year. Regeneron rose more than 9% in pre-market trading in New York.

The positive data could herald a new era of cutting-edge treatments for the life-threatening respiratory affliction. 

“This was a high-risk study,” Mark Purcell, an analyst at Morgan Stanley, wrote in a note. “With the strength of the data, peak penetration could be higher than we previously expected” and revenue generated from CODP could exceed the €2 billion ($2.1 billion) he and colleagues had forecast.

Dupixent, which is already prescribed for asthma and some skin conditions, showed a 30% reduction in the rate at which patients’ COPD worsened compared to those who received a placebo during an advanced trial called Boreas. 

Dupixent improved people’s lung function and quality of life, showing results that are “unprecedented and potentially paradigm-shifting,” said Dietmar Berger, Sanofi’s chief medical officer.

Sanofi probably needs Dupixent to also perform well in a related trial before it can apply for regulatory approval, according to Tim Anderson, an analyst at Wolfe Research. That study, called Notus, likely won’t yield results until next year. 

Common among current and former smokers, among others, COPD damages people’s lungs and can cause persistent coughing and breathlessness, along with anxiety, depression and sleep disturbances. In the US, some 300,000 people suffer from the type of COPD that was included in this trial, Sanofi noted.

The French drugmaker has a peak sales forecast of more than €13 billion for Dupixent that doesn’t include any potential revenue for treating COPD. Some analysts are already forecasting that Dupixent will hit as much as €18 billion in sales by 2030.

–With assistance from Jonathan Roeder.

(Updates with pre-market shares in fourth paragraph)

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