Over the course of 2020, Sanofi saw significant growth in its specialty care sales primarily driven by its blue-chip asset, Dupixent, as well as an increase in vaccine sales that were driven by demand for differentiated influenza vaccines, the company announced in its year-end financial report.
For the year, Dupixent generated €3.5 billion (about $4.2 billion) for Sanofi. Dupixent, which was co-developed with Regeneron, continues to be a significant driver for Sanofi. In its year-end financial report, Sanofi said sales of Dupixent were driven by continued strong demand in atopic dermatitis (AD) in adult and adolescent patients, rapid adoption in children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis. By the end of 2020, Dupixent has become available in 47 different countries with approximately 230,000 patients on therapy, Sanofi said.
Earlier this year, during a call ahead of the J.P. Morgan Healthcare conference, Frank Nestle, Sanofi’s chief scientific officer and Global Head of Research, and Dietmar Berger, Sanofi’s chief medical officer and Global Head of Development, predicted 2021 will be a transformative year for the company. Dupixent plays a significant role in that future, they said.
Sanofi Chief Executive Officer Paul Hudson touted the company’s progress in 2020, despite some limitations imposed by the COVID-19 pandemic. He noted the continued uptake in Dupixent use across the globe and also pointed to potential approvals in new indications for the monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins. The company anticipates approval of Dupixent in pediatric asthma this year.
Other highlights for Sanofi include multiple acquisitions that are expected to provide the company a strong standing in areas like, immune-oncology, synthetic biology and cell and gene therapy. The company is also aiming for innovations with protein degraders, antibody conjugates, nanobodies and multi-specific antibodies, specifically bi- and tri-specific.
Hudson also pointed to its ongoing COVID-19 vaccine development programs. He said clinical trials are expected to begin on its vaccine candidates. Hudson also said the company is making a more immediate contribution to the pandemic fight by providing manufacturing support to BioNTech and Pfizer.”
The year-end report wasn’t all positives. Sanofi reported a few setbacks, including a Phase II Parkinson’s disease study with venglustat. Sanofi said the Phase II study of Parkinson’s disease patients with GBA mutations did not meet the primary endpoint at the end of January and the study for this indication was halted. The disclosure is a setback for the company’s plans for venglustat. Ahead of the J.P. Morgan conference, company officials said venglustat had the potential to be a pipeline in a pill. The venglustat safety profile continues to be favorable and the development moves forward as planned in other Rare Disease indications, the company said. Venglustat is being assessed in other studies, including Phase III programs for GM2 Gangliosidosis and Autosomal Dominant Polycystic Kidney Disease, as well as Phase II studies in Fabry disease and Gaucher disease Type 3.
Other programs that will not continue include the anti-IL4/IL13 bispecific mAb Romilkimab, which was in a Phase II study for systemic scleroderma, as well as asthma treatment Itepekimab and lymphoma treatment Isatuximab. Both of those were also in Phase II.
Sanofi said it is working to resolve a Complete Response Letter issued by the U.S. Food and Drug Administration during the fourth quarter for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. The CRL was issued due to manufacturing concerns. There were no clinical concerns. Sanofi said it is working with both the FDA and the third-party manufacturer to reach a resolution in a timely manner.