(AOF) – Sanofi announced that it has entered into an agreement with Janssen Pharmaceuticals, a company of the Johnson & Johnson group, for the development and commercialization of a 9-valent vaccine candidate against extra-intestinal pathogenic strains of E . coli developed by Janssen. This vaccine candidate is currently the subject of a phase III clinical trial. This new vaccine against extraintestinal pathogenic strains of E. coli should complement the French pharmaceutical group’s current portfolio of vaccines intended for older adults.
Under the terms of the agreement, both parties will co-finance current and future research and development expenses. Sanofi will make an upfront payment of US$175 million to Janssen, followed by milestone payments based on the achievement of certain development and commercial objectives.
A profit sharing agreement will be put in place in the United States, in four countries of the European Union (Germany, Spain, France, Italy), as well as in the United Kingdom. Elsewhere in the world, Janssen will receive tiered royalties and milestone payments based on sales achieved. The fence is subject to customary regulatory approvals.
E. coli is a significant cause of sepsis, mortality and antibiotic resistance in older adults and the number of cases is increasing as the population ages,” explained Thomas Triomphe, Executive Vice President, Vaccines, Sanofi.
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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.
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Biotechs put to the test
These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in venture capital financing of start-ups. These companies are therefore obliged to carry out layoff plans. Added to this is a much more restrictive regulatory framework. First, in the United States, measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of stakeholders. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemical) or 13 years (biological), with discounts that could range from 35 to 60% for biotechs. Likewise, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.