(RTTNews) – Swedish Orphan Biovitrum AB or Sobi (SWTUY.PK) said that it has streamlined nirsevimab contractual arrangements. Nirsevimab economics simplified through a new royalty agreement with Sanofi and the termination of the participation agreement with AstraZeneca.
Sobi completed the acquisition of Synagis (palivizumab) in January 2019 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.
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.
Sobi, through a new royalty agreement with Sanofi, 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, the Swedish biopharmaceutical company said in a statement on Sunday.
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.
Meanwhile, Sobi said it terminated the participation agreement with AstraZeneca 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 noted that it will pay AstraZeneca $15 million as an upfront final consideration with Sobi owing no further payments.
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