(News Bulletin 247) – The pharmaceutical group’s flagship drug has reached its primary endpoint in the treatment of chronic obstructive pulmonary disease, nicknamed “smoker’s bronchitis”.

If Sanofi experienced a series of disappointments last year on its therapeutic trials, the pharmaceutical group can count on its flagship drug, Dupixent, co-developed with the American Regeneron.

Already benefiting from numerous indications, such as asthma or atopic dermatitis, Sanofi’s blockbuster is well on its way to adding a new string to its bow.

The company thus announced that Dupixent had reached its primary endpoint in a phase III study, the last stage of clinical trials before potential marketing, evaluating the drug in the treatment of chronic obstructive pulmonary disease (COPD).

“Smoker’s Bronchitis”

COPD is a potentially life-threatening respiratory disease that damages the lungs and leads to a progressive deterioration of respiratory function. Its symptoms include a chronic cough and shortness of breath which can not only affect the ability to perform certain daily activities, but also cause anxiety, depression and sleep disturbances.

Very present in smokers, this disease is also nicknamed “smoker’s bronchitis”. In the United States, 300,000 people have COPD with type 2 inflammatory signature.

The phase III trial evaluated Dupixent versus placebo in adults with these disease features. In the end, Dupixent resulted in a clinically and highly significant reduction, i.e. by 30%, of moderate or severe acute exacerbations of COPD (rapid and acute deterioration of respiratory symptoms), as well as improvements significant changes in respiratory function, quality of life, and respiratory symptoms due to disease.

“In this landmark Phase III trial, patients with uncontrolled COPD treated with Dupixent showed clinical results never before seen with a biologic drug,” said Regeneron’s Chief Scientific Officer. , George Yancoupolos, quoted in the press release.

Sanofi is delighted that Dupixent could potentially become “the first biological drug” for the treatment of COPD. The detailed efficacy and safety results of this trial will be presented at an upcoming scientific conference.

A third of sales in 2029

The market welcomes this announcement, the Sanofi title taking 4.8% around 10:40 a.m., signing the largest increase in the CAC 40.

“This is excellent news that could provide a very important new indication for Dupixent, whose sales expectations will be clearly revised upwards by the market,” said an analyst.

Sanofi had indicated that it was expecting a peak in sales generated by Dupixent of more than 13 billion euros on an annual basis. A cautious forecast, analysts’ targets being well above.

According to Richard Vosser, an analyst at JPMorgan quoted by Reuters, the market consensus for Dupixent sales in 2027, which stands at 15.7 billion euros, should be exceeded by the order of one to two billion euros. euros.

UBS estimates, for its part, that Dupixent could generate 17 billion euros in sales in 2029, then representing a third of the French group’s total, a forecast which does not include the potential benefits of an indication for uncontrolled COPD. .

“Although this is the seventh inflammatory disease for which Dupixent reveals positive clinical results, this news should be very well perceived by the market because these clinical results open a significant market and were uncertain”, explains for its part Invest. Securities.

“Indeed, there have been many failures in pathology, including competing drugs in asthma (Fasenra and Nucala from AstraZeneca and GSK). Additionally, the latest pivotal trials of Dupixent excluded patients with asthma, which could reduce the odds of a positive result in COPD The exclusion of patients with asthma was linked to concerns that the drug’s effects on asthma were driving the efficacy in [BPCO]. The FDA [l’autorité sanitaire américaine, NDLR] had criticized GSK’s essay on this point”, continues the financial intermediary.

Still, if this announcement demonstrates a little more the potential of Dupixent, it has the flip side of further emphasizing Sanofi’s dependence on this drug…