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News

Sobi to streamline nirsevimab contractual arrangements

Read time: 1 mins
Published: 10th Apr 2023

Sobi announced a streamlining and simplification of the contractual economics for nirsevimab

In January 2019, Sobi completed the acquisition of Synagis (palivizumab) from AstraZeneca in the US as well as the right to AstraZeneca's full share of US profits and losses for nirsevimab. Synagis is a medicine used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children. Nirsevimab is under regulatory review in the US and recently approved in the EU for the prevention of RSV lower respiratory tract disease in new-borns and infants.

Through a new royalty agreement with Sanofi, Sobi will receive a quarterly royalty on net sales of nirsevimab in the US. Royalty rates will start at 25 per cent at launch, which is anticipated in 2023, continue in 2024 and increase each year from 2025 to 2028 in a tiered fashion to a range of 30 to 35 per cent of net sales. Beyond 2028, the royalty rates will remain at these levels. As part of the new royalty agreement with Sanofi, Sobi will pay Sanofi $ 66 million as reimbursement of prior costs for research & development of nirsevimab in the US with Sobi owing no further payments.

Through a separate agreement with AstraZeneca, Sobi terminated the participation agreement related to nirsevimab that was entered into at the end of 2018 and closed in January 2019. This termination removes Sobi's right to AstraZeneca's full share of US profits and losses for nirsevimab, including US development and commercialisation costs and the obligation to pay future milestones and royalties to AstraZeneca. Sobi will pay AstraZeneca $ 15 million as an upfront final consideration with Sobi owing no further payments.

About Synagis- Synagis (palivizumab) is an RSV F protein inhibitor monoclonal antibody immunisation indicated for the prevention of serious lower respiratory tract infection caused by RSV in infants and young children at high risk of RSV disease.

About nirsevimab- Nirsevimab, formerly MEDI8897, is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi. It is designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Condition: Respiratory Syncytial Virus
Type: drug
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