Sanofi: Sanofi’s flagship drug well on its way to obtaining a new indication in the United States


(BFM Bourse) – The pharmaceutical group and its partner Regeneron announced that the American health authority had granted priority review to Dupixent for the treatment of chronic rhinosinusitis with nasal polyposis in adolescents.

Sanofi is one of the companies taking center stage this Monday. The pharmaceutical group announced this Monday an additional investment of 1.1 billion euros in France in the production of medicines. This announcement comes in the middle of the “Choose France” summit, an event intended to highlight the attractiveness of France. Sanofi’s investment joins a list that also includes Microsoft, Amazon and Morgan Stanley.

Another announcement went a little more unnoticed. Sanofi and its American partner Regeneron indicated on Monday that the Food and Drug Administration (FDA) had granted priority review to their blockbuster, Dupixent, in the treatment of chronic rhinosinusitis with nasal polyposis in adolescents aged 12 to 17 years. . The drug is already approved for adults.

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Chronic rhinosinusitis with nasal polyposis is a chronic disease that obstructs the sinuses and nasal passages. “It can lead to difficulty breathing, congestion and runny nose, decreased or loss of sense of smell and taste, facial pressure, sleep disturbances and an overall reduction in quality of life,” explains Sanofi. Furthermore, patients with this disease often suffer from another inflammatory disease, such as asthma.

If Dupixent were approved by the FDA, it would be the first drug indicated for adolescents to treat chronic rhinosinusitis with nasal polyposis.

On the Paris Stock Exchange, Sanofi shares rose 1.3% following these announcements.

A dependence that Sanofi seeks to reduce

Dupixent remains Sanofi’s big blockbuster. This anti-inflammatory has multiple indications such as atopic dermatitis or asthma and could benefit from other potential indications such as that for the treatment of “smoker’s bronchitis”. In 2023, sales of Dupixent increased by 34% to reach 10.72 billion euros and Sanofi is targeting revenues of 13 billion euros this year. According to UBS, the figure could reach 21.5 billion euros by 2030.

However, the success of Dupixent has often been the tree that hides the forest for Sanofi. The group has suffered several setbacks in recent years, whether in the development of its own drugs (with the discontinuation of amcenestrant in 2022) or in terms of its mixed record in terms of external growth.

The dependence of Sanofi’s growth on Dupixent is also a recurring source of market concern. To try to remedy this issue and boost its growth, the group decided in the fall to double down on R&D (hence also the investment in France announced this Monday).

Sanofi has identified 12 molecules currently in clinical trials, each with a sales potential of between 2 and 5 billion euros, i.e. a potential ranging from 33 billion to more than 60 billion euros. Sanofi expects to submit these molecules for regulatory authorization between 2024 and 2027 for five of them and beyond 2027 for the other seven.

Furthermore, the Stifel bank confirmed its purchase advice on the stock this Monday, following an interview with the new financial director, François-Xavier Roger. “We emerged reasonably confident in our key assumptions relating to the group’s growth trajectory,” the bank wrote.

Julien Marion – ©2024 BFM Bourse

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