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Sanofi: positive results for acoziborole against sleeping sickness in Africa – 11/30/2022 at 10:27


(AOF) – Sanofi announces the publication today in the medical journal The Lancet Infectious Diseases, of therapeutic success rates of up to 95% in the context of a phase II/III study on the safety and efficacy of a single dose of acoziborole, an experimental drug that could transform the treatment of sleeping sickness. This clinical trial was conducted between 2016 and 2019 by the DNDi (Drugs for Neglected Diseases initiative) and its partners in the Democratic Republic of Congo (DRC) and Guinea.

The number of sleeping sickness cases reported over the past 20 years has fallen sharply, from almost 40,000 reported cases in 1998 (plus an estimated 300,000 undiagnosed cases) to less than 1,000 in 2020. While this is an encouraging trend, vigilance is still required as this disease can re-emerge in devastating outbreaks.

Dr. Victor Kande, principal investigator of the clinical trial and lead author of the article in The Lancet points out that “sleeping sickness is a nightmarish disease that strikes people living in the most remote regions of East Africa. west and centre, where the distance to the nearest hospital is sometimes days”. For him “we are now on the verge of having a potential treatment, to be taken only once in three tablets, which would be a real revolution for doctors and the populations of the affected regions. ”

Acoziborole is in clinical development and no regulatory body has yet evaluated its safety and efficacy profiles.

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Key points

– 5th worldwide pharmaceutical group, created in 1994, first in Europe, and 1st 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 of €12.2 billion and free cash flow of €3.2 billion at the end of June.

Challenges

– 2020-2025 “Play to win” plan aimed at creating an agile group and world number 2:

– 2020/22: operating margin of 30%, €2.5 billion in cost savings,

– 2023/25: reduction of 1/3 of product families, productivity driven 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, 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 by 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 2050,

– 2030: 55% reduction in CO2 emissions for scopes 1 & 2 and 30% for scope 3,

– 2027: elimination of plastic packaging for vaccines,

– 2025: eco-design of all new products;£

– 2022: launch of Impact, drugs sold without profit in 40 poor countries,

– issues 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):

– Commercial monitoring of drugs approved by the FDA (Dupixent) or recognized as innovative (Efanesoctocog alpha for haemophilia) 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, strengthening the R&D portfolio of biological agents.

Challenges

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

– Russian-Ukrainian conflict: risk of delay in completing clinical trials on patients in Multiple Sclerosis and Chronic Obstructive Pulmonary Disease;

– Follow-up of preliminary approvals: Altuvilio (priority review granted by the FDA) and CHMP recommendations for Beyfortus and Enjaymo;

– After the strong jump in revenues, driven by vaccines in the 3rd quarter, 2nd increase in the 2022 objective of growth of at least 16% in earnings per share.

An inevitable race for new blockbusters

The patent for Merck’s star product, the cancer drug Keytruda, which accounts for more than 35% of its sales, expires in 2028. Despite the loss, since 2019, of the patents for its three star products (Avastin, Herceptine, Rituxan) Roche was able to renew its portfolio by bringing new molecules to market. However, the discovery and launch of new drugs are increasingly expensive. AstraZeneca spends about $6 billion a year on R&D in a pharmaceutical industry where the life of a patent only lasts ten to fifteen years. This leads laboratories to withdraw from certain activities. Thus J&J, Pfizer, GSK and, no doubt, Novartis soon prefer to refocus on specialty drugs and abandon any ancillary activity.



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