(AOF) – The Sanofi stock (-3.33% to 84.75 euros) ended Thursday’s session at the low point of the Paris Stock Exchange’s Star Index. On Tuesday, the pharmaceutical company announced the suspension of recruitment for clinical trials of tolebrutinib, an experimental treatment for multiple sclerosis (MS). On the same day, UBS downgraded its Buy rating to Neutral and lowered its price target from EUR118 to EUR103. He expects earnings growth to slow in 2023 due to difficulties with amcenestrant, a breast cancer treatment, and tolebrutinib.
Sanofi has therefore announced the suspension of recruitment for clinical trials of tolebrutinib, an investigational treatment for certain forms of multiple sclerosis and myasthenia gravis.
The FDA’s Independent Data Monitoring Committee (iDMC), which oversees tolebrutinib clinical trials, has requested the suspension of recruitment for all of these trials worldwide.
At the end of June, the American health authorities had already applied for a partial suspension of the studies in the USA after several cases of liver damage in connection with the treatment.
Per the iDMC recommendation, all participants currently receiving tolebrutinib in all studies will continue treatment according to study protocols, Sanofi said.
The group assures that it is working closely with regulators to resume active recruitment in the fourth quarter of 2022.
Sanofi is committed to providing the FDA with the requested information by the end of September 2022.
The company also adds that the regulatory deadlines for this indication remain unchanged, with a filing in recurring MS planned for 2024.
AOF – LEARN MORE
Global pharmaceutical group, founded in 1994, first in Europe and 1
in vaccines worldwide;
– Balanced turnover of 37.8 billion euros from 4 business areas: general medicine for 34%, specialty medicine (immunology, neurology and oncology) for 35%, vaccines for 20% and consumer healthcare;
– Growing share of emerging markets (34% of sales) behind the United States (38%) and Europe (28%);
– Business model in 4 points: a simplified organization, a restructured portfolio with 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 the shares and 16.95% of the voting rights), Serge Weinberg as Chairman of the 16-member Board of Directors, Paul Hudson as CEO;
– Healthy balance sheet with net debt reduced to 8.8 billion euros and free cash flow of 8.1 billion euros.
– 2020-2025 “Play to win” plan aimed at creating an agile group and number 2 in the world, articulated in 2 phases: 2020/22: 30% operating margin, 2.5 billion euros on Cost savings / 2023/25: 1/3 reduction in product families and productivity driven by R&D and digital in factories, operating margin of 32%;
– Innovation Strategy: 5 Research Areas: Immunology & Inflammation, Oncology, Neurology (especially Sclerosis), Rare Haematology & Rare Diseases, Vaccines / 91 ongoing projects, 29 of which are in phase 3 and 5 awaiting regulatory approval / co-developed – Kymera for immunology , Translate Bio into 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 with the goal of 2030 carbon neutrality in 2030, 100% sustainable electricity consumption vs. 50% in 2021 and 100% sustainable vehicle fleet vs. 22% / in 2027, elimination of plastic packaging for vaccines / in 2025 eco-design of all new products / Introduction of credit lines indexed to sustainable development;
– Effect of the 5 “priority” drugs: amcenestrant (breast cancer), fitusiran (RNA for hemophilia), efanesoctocog (hemophilia), nirsevimab and nisevimab (respiratory viruses) and tolebrutinib (multiple sclerosis):
– Following Origimm, a specialist in skin disease research, Kadmon and Owkin agree to acquire Amunix in immuno-oncology to strengthen its R&D portfolio of biological agents.
– Image tarnished by the delay of the Covid 19 vaccine;
– IPO of EUROAPI, a group born from the group’s activities in the production of active pharmaceutical ingredients or APIs in Europe, with shareholders receiving 1 EUROAPI share for 23 shares and the capital divided between Sanofi 30% and BPIFrance 12 % is divided;
– 2022 growth target of at least 10% of earnings per share;
– Dividend 2021 of €3.33.
An inevitable race for new blockbusters
The patent on Merck’s star product, cancer drug Keytruda, which accounts for more than 35% of sales, expires in 2028. Despite losing the patents for its three star products (Avastin, Herceptine, Rituxan) since 2019, Roche has been able to renew its portfolio by launching new molecules. However, discovering and bringing new drugs to market is becoming increasingly expensive. AstraZeneca spends approximately $6 billion annually on research and development in a pharmaceutical industry where the lifespan of a patent is only 10 to 15 years. This means that laboratories are withdrawing from certain activities. Thus, J&J, Pfizer, GSK and no doubt Novartis will soon prefer to refocus on specialty drugs and ditch all ancillary activities.