Cost-Cutting Sanofi Resumes Fitusiran Studies, Starts COVID Vaccine Phase IIb This Month
2020 Revenues Led By Dupixent, Vaccines
Executive Summary
Dupixent was Sanofi’s top-selling product in 2020, but its vaccines division also saw significant growth in the year led by its differentiated influenza vaccines, which helped drive the big pharma’s business during the year, accompanied by significant cost savings.
Sanofi has restarted Phase III clinical trials with a potential RNA-interference based hemophilia therapy, fitusiran, and expects to start Phase IIb studies this month with its COVID-19 vaccine candidate developed in collaboration with GlaxoSmithKline plc, but the multinational has halted Phase II studies in Parkinson’s disease of another high-profile product candidate, venglustat.
Phase III studies of fitusiran were put on hold late last year because of side effect concerns including non-fatal thrombotic events, but the studies have now resumed, Sanofi highlighted in its 2020 financial results reporting on 5 February. An amended clinical trial protocol is being presented today at the European Association of Haemophilia and Allied Disorders (EAHAD) congress, which includes a lower starting dose and the dosing interval extended to every other month, noted chief medical officer Dietmar Berger.
Fitusiran is a potential first-in-class therapy for hemophilia, which is being evaluated as a once-monthly subcutaneous injection for both hemophilia A and hemophilia B patients, with and without inhibitors and without the need for refrigeration, and so could be a significant competitor to Roche Holding AG’s blockbuster hemophilia therapy, Hemlibra (emcizumab). Phase III studies have restarted in adolescents and adults, and fitusiran has been granted fast track designation by the US FDA. (Also see "Sanofi Hampered By Fitusiran Clinical Hold In Hemophilia" - Scrip, 9 Nov, 2020.)
The second pipeline change highlighted by Sanofi was the halt to the evaluation of venglustat in Parkinson’s disease, although studies continue in other indications. Venglustat is being developed as a next-generation oral, brain-penetrating glycosylceramide synthase inhibitor, which has shown proof-of-concept in Gaucher type 3 and Fabry diseases, but a Phase II study in patients with Parkinson’s disease and GBA mutations (the gene encoding glucocerebrosidase) has failed to meet its primary endpoint.
Secondary efficacy endpoints were also missed, but glycosphingolipid levels in CSF declined and venglustat was well tolerated, and development continues in autosomal-dominant polycystic kidney disease (ADPKD) and in lysosomal storage diseases. (Also see "No Looking Back For Sanofi In R&D Turnaround Quest" - Scrip, 26 Jun, 2020.)
Early studies of Sanofi/GSK’s COVID-19 vaccine candidate were associated with a poor immune response in elderly individuals, but an improved antigen formulation has been developed and will be evaluated with support from the US Biomedical Advanced Research and Development Authority (BARDA), Sanofi noted. Phase IIb studies are expected to start this month.
Among other late-stage products, Sanofi announced the start a Phase III study, AERIFY-1 of the anti-IL-33 Mab, itepekimab, in chronic obstructive pulmonary disease, the start of a Phase III study of amcenestrant with palbociclib as a first-line therapy for ER-positive, HER2 negative advanced breast cancer, and the start of a Phase III study, LUNA3, of rilzabrutinib in persistent or chronic immune thrombocytopenia.
And clinical studies have begun on potential additional indications for Dupixent (dupilumab), including in chronic inducible cold urticaria, chronic sinusitis without nasal polyps, and allergic fungal rhinosinusitis.
Dupixent And Vaccine Sales Soar
During 2020, Sanofi’s vaccines business, and its dual IL-4/IL-13 inhibitor, Dupixent (dupilumab) drove the company’s sales growth, with the latter being Sanofi’s top-selling product with sales of €3.5bn, an increase of 74%. The monoclonal antibody increased its penetration of atopic dermatitis and asthma markets, and gained launches in more countries and new indications in younger populations.
Vaccines sales grew by 8.8% at constant exchange rates to reach €5.9bn in the year, led by its sales of its influenza vaccines, which grew by 38% to reach €2.5bn. In contrast, pharmaceutical sales only increased by 3.1% in 2020, but they did achieve sales of €25.7bn. Sanofi’s total revenues reached €36bn.
The performance of the vaccines division was a “positive surprise” according to analysts at Bryan, Garnier & Co. More importantly, Sanofi did not convey the same negative message for 2021 as GlaxoSmithKline, due to differences in their vaccine portfolios, the analysts added.
Much of Sanofi’s research effort is into developing a new generation of oncology products; its current top-selling oncology product, Jevtana (cabazitaxel), had sales of €536m in 2020, but it is expected to face generic competition in Europe from the end of March 2021, while in the US, patent infringement suits are underway. The checkpoint inhibitor, Libtayo (cemiplimab), which Sanofi markets outside the US, had sales of €67m in 2020 for the company, driven by new country launches; it is now available in 18 countries outside the US.
Sales of the MS therapy, Lemtrada, declined by 58.7% at CER in the year to €113m, primarily due to the COVID-19 pandemic, which has led to decreases in infused immune reconstitution therapies, the company noted.
In 2021, Sanofi expects business EPS to grow by high single digits at constant exchange rates, with currency headwinds holding this back by between 4.5% and 5.5%. In 2020, business EPS was €5.86, up 3.9% on a reported basis and 9.2% at CER, ahead of guidance of 7% to 8%.
The company reported that it had already garnered €1.7bn in savings under its current program that called for savings of €2bn by 2022, and had called for additional savings of €500m by 2022 which would be invested back into the business.