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Sanofi: good news for Dupixent in the United States – 05/23/2022 at 07:55


(AOF) – The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) 300 mg once weekly for the treatment of eosinophilic esophagitis in patients ages 12 and older, weighing at least 40 kg. “With this approval, Dupixent becomes the first and only drug specifically indicated for the treatment of eosinophilic esophagitis in the United States,” said Sanofi.

The application for approval in this indication is currently being reviewed by the European Medicines Agency and regulatory submissions elsewhere in the world are also expected by the end of 2022.

AOF – LEARN MORE

Key points

– 5

th

global pharmaceutical group, created in 1994, first in Europe, and 1

er

worldwide in vaccines;

– Balanced sales of €37.8 billion from 4 divisions: general medicine for 34%, specialty medicine (immunology, neurology and oncology) for 35%, vaccines for 20% and consumer healthcare;

– Growing share of emerging countries (34% of sales) behind the United States (38%) and Europe (28%);

– Business model in 4 points: a simplified organization, a restructured portfolio containing more organic products, a 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 16-member board of directors, Paul Hudson being CEO;

– Healthy balance sheet with net debt reduced to €8.8 billion and free cash flow of €8.1 billion.

Challenges

– 2020-2025 “Play to win” plan aimed at creating an agile group and the world’s No. /25: reduction of 1/3 of product families and productivity driven by R&D and digital in factories, 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, including 29 in phase 3 and 5 awaiting approval by the authorities / developed in collaboration -Kymera for immunology, Translate Bio in RNA for vaccines- or through acquisitions -Kiadis, Biopharma, Kymab for oncology / supported by technological platforms: small molecules, antibodies, hemogenetic proteins, genomics ;

– Planet Mobilization environmental strategy aiming for carbon neutrality by 2030, 100% sustainable electricity consumption against 50% in 2021 and 100% of the sustainable car fleet against 22% / in 2027, elimination of plastic packaging for vaccines / in 2025, eco-design of all new products / launch of lines of credit indexed to sustainable development;

– Impact of the 5 “priority” drugs: Amcenestrant (breast cancer), Fitusiran (RNA for hemophilia), Efanesoctocog (hemophilia), Nirsevimab and Nisevimab (respiratory viruses) and Tolebrutinib (multiple sclerosis):

– After Origimm, specialized in research on skin conditions, Kadmon and Owkin, agreement to acquire Amunix in immuno-oncology, strengthening the R&D portfolio of biological agents.

Challenges

– Image tarnished by the delay of the vaccine against Covid 19;

– IPO of EUROAPI, a group created from the group’s activities in the production of active pharmaceutical ingredients or APIs in Europe, shareholders receiving 1 EUROAPI share for 23 shares and the capital being divided between Sanofi for 30% and BPIFrance for 12 %;

– 2022 objective of growth of at least 10% in earnings per share;

– 2021 dividend of €3.33.

Oncology supports laboratory performance

Oncology generated $163 billion in revenue in 2021 (out of an industry total of $613 billion), up 11.9%, according to GlobalData. Its average annual growth has reached 15.4% over the past twenty years. This segment, which is increasingly competitive, is dominated by a few heavyweights such as MSD (Merck & Co. Inc), Roche, BMS

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immuno-oncology, the specialty that has been driving this market for ten years, supports research. GlobalData estimates that this segment could reach 180 billion in 2026. The major players are looking to strengthen themselves in this niche. Pfizer recently acquired Canadian biotech Trillium Therapeutics for $2.3 billion. Following this operation, the American group got hold of two promising molecules in the treatment of blood cancer.



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