# AstraZeneca updates contractual arrangements with Swedish Orphan Biovitrum AB and Sanofi

- Link: https://www.directorstalkinterviews.com/astrazeneca-updates-contractual-arrangements-with-swedish-orphan-biovitrum-ab-and-sanofi/4121114054
- Published: 2023-04-11T07:25:31+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)),
Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified
their contractual arrangements relating to the development and commercialisation
of nirsevimab in the US. Given the upcoming launch of nirsevimab in the US and other
markets, simplification of the prior arrangements clarifies the roles and responsibilities
of relevant parties.   

Under the updated arrangements, Sobi has entered into a direct relationship with
Sanofi, replacing the previous participation agreement with AstraZeneca entered 
into in November 2018. Under the previous agreement, from the day of the transaction
with Sobi, AstraZeneca had to provision the risk adjusted value of the discounted
cash flow of future payments to be made to Sobi as a liability. As a result of this
simplification agreement, Sanofi will pay royalties to Sobi as US nirsevimab sales
arise, and the liability related to future obligations is eliminated. AstraZeneca
will record a gain of $0.7 billion, to be recognised in Core Other operating income
in 2023. This does not impact AstraZeneca’s financial guidance for 2023.

**About nirsevimab**

Nirsevimab is a single dose long-acting antibody, developed and commercialised in
partnership by AstraZeneca and Sanofi using AstraZeneca’s YTE technology. It is 
designed to protect infants entering or during their first respiratory syncytial
virus (RSV) season and for children up to 24 months of age who remain vulnerable
to severe RSV disease through their second RSV season. Nirsevimab has been developed
to offer newborns and infants direct RSV protection via an antibody to help prevent
lower respiratory tract disease (LRTD) caused by RSV. Monoclonal antibodies do not
require the activation of the immune system to help offer timely, rapid and direct
protection against disease.^(1)

In November 2022, _Beyfortus_ was approved by the European Commission and by the
UK Medicines and Healthcare products Regulatory Agency (MHRA).^(2-3)

**Sanofi Alliance**

In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise
nirsevimab. Under the terms of the agreement, AstraZeneca leads development and 
manufacturing activities, and Sanofi leads commercialisation activities and records
revenue. Under the terms of the global agreement, Sanofi made an upfront payment
of €120m, has paid a development milestone of €30m and will pay further milestones
subject to achievement of certain development and sales-related milestones. The 
two companies share costs and profits. Revenue from the agreement is reported as
Alliance Revenue and Collaboration Revenue in the Company’s financial statements.

**Sobi Transaction**

In November 2018, AstraZeneca announced that it had agreed to sell the US commercial
rights for _Synagis_ (palivizumab), and the right to participate in the US profits
or losses for nirsevimab, to Sobi (the 2018 announcement).

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