(AOF) – Sanofi announces that the FDA grants priority review to the biologics license application for Dupixent for the treatment of chronic obstructive pulmonary disease (COPD) with type 2 inflammation. This priority review is granted on the basis of positive results from two phase III trials.
The laboratory specifies that if approved, Dupixent would become the only biologic drug for the treatment of COPD and the first new drug indicated for this disease in more than a decade, and that regulatory submissions are also under review in China and the European Union.
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Key points
– 5th global pharmaceutical group, created in 1994, 1st in Europe, and 1st worldwide in vaccines;
– Sales of €43 billion from 4 divisions: specialty medicine (immunology, neurology and oncology) for 41%, general medicine for 31.5%, vaccines for 16% and general public health;
– Growing share of the United States in sales (43.6%) ahead of Europe (24.6%) and the rest of the world 31.8%;
– 4-point business model: a simplified organization, a restructured portfolio containing more organic products, transformed R&D and strong ambitions in terms of profitability and financial solidity;
– Split capital (excluding L’Oréal: 9.48% of shares and 16.95% of voting rights), Serge Weinberg chairing the board of directors of 16 members, Paul Hudson being general manager;
– Very solid balance sheet, €73.5 billion in equity, €6.4 billion in net debt and €8.5 billion in free self-financing.
Challenges
– “Play to win” 2025 plan aimed at creating an agile group that is number 2 in the world:
– 2023/25: reduction of 1/3 in product families, productivity guided by R&D and digital in factories and operating margin of 32%;
– Innovation strategy:
– 5 areas of research: immunology & inflammation, oncology, neurology (particularly sclerosis), rare hematological diseases & rare diseases, vaccines,
– 91 projects in progress, 1/3 of which are in phases 3 and 5 awaiting visas from the authorities,
– developed in collaboration -Kymera for immunology, Translate Bio in RNA for vaccines- or by acquisitions -Kiadis, Biopharma, Kymab for oncology,
– supported by technological platforms: small molecules, antibodies, proteins, hemogenetics, genomics;
– Planet Mobilization environmental strategy aiming for total carbon neutrality by 2045:
– 2027: elimination of plastic packaging for vaccines,
– 2025: eco-design of all new products;
– issues of credit lines indexed to sustainable development;
– Outcomes of the 5 “priority” drugs: Amcenestrant (breast cancer), Fitusiran (RNA for hemophilia), Efanesoctocog (hemophilia), Nirsévimab and Nisévimab (respiratory viruses) and Tolebrutinib (multiple sclerosis):
– Commercial monitoring of drugs approved by the FDA (Dupixent) or recognized as innovative (Efanesoctocog alpha for hemophilia) and approved by the European Commission (Nexviadyme and Xenpozyme);
– After Origimm, specialized in research on skin conditions, Kadmon and Owkin, acquisition of Amunix in immuno-oncology (biological agents) and expansion of the collaboration with Innate Pharma (natural killer cells).
Challenges
– Resistance to competition from Aubagio generics, launched in the first half;
– Monitoring of approvals from regulatory authorities: Altuviliol and Beyfortus, launched in 2023, and Enjaymo;
– Positive phase 2/3 results for Acoziborole (sleeping sickness);
– After the 8% increase in 2022 results, 2023 expectations: €10 billion in sales for Duplixent and earnings per share growth of less than 10%;
– 2022 dividend of €3.56.
Learn more about the Pharmacy sector
Oncology, priority of pharmaceutical giants
Sanofi’s stock market disappointment recorded at the end of October 2023 underlines the new direction for the group, which has now set oncology as its number 1 priority. Efforts in this segment, where therapies are advancing the fastest, notably involve investments in R&D which weigh on profitability. Sanofi therefore announced a drop in its earnings per share in 2024 and the abandonment of its objective of an operating margin of 32% in 2025. Merck has just unveiled a new alliance. It will pay up to $22 billion to the Japanese group Daiichi Sankyo as part of a partnership on experimental cancer treatments. While some experts estimate that the United States represents nearly half of global oncology spending (drugs and treatments), or $196 billion in 2022, Chinese spending in this area has more than doubled in five years, going from 5 to 11.8 billion dollars.