AstraZeneca restructures nirsevimab agreements with Sobi and Sanofi
AstraZeneca, Sobi and Sanofi have simplified their US development and commercialisation agreements for nirsevimab. AstraZeneca will recognise a $0.7 billion gain from the arrangement changes.
AstraZeneca, Swedish Orphan Biovitrum AB (Sobi), and Sanofi have updated and simplified their contractual arrangements concerning the development and commercialisation of nirsevimab in the United States. These changes aim to clarify the roles and responsibilities of each party ahead of the drug's upcoming launch in the US and other markets.
Under the revised terms, Sobi will enter into a direct relationship with Sanofi, replacing the previous participation agreement Sobi had with AstraZeneca, established in November 2018. Previously, AstraZeneca was responsible for provisioning the risk-adjusted value of future payments to Sobi. With this simplification, Sanofi will now pay royalties to Sobi as US nirsevimab sales occur, eliminating AstraZeneca's liability for these future obligations. Consequently, AstraZeneca will record a gain of $0.7 billion in 2023, which does not impact its financial guidance for the year.
Nirsevimab is a long-acting antibody developed jointly by AstraZeneca and Sanofi to protect infants and young children from severe respiratory syncytial virus (RSV) lower respiratory tract disease. The antibody received regulatory approval in the European Commission and the UK's MHRA in November 2022.
The collaboration between AstraZeneca and Sanofi on nirsevimab began in March 2017, with AstraZeneca leading development and manufacturing, and Sanofi overseeing commercialisation. AstraZeneca had previously sold the US commercial rights for nirsevimab to Sobi in November 2018.