REG - AstraZeneca PLC - Update to arrangements with Sobi and Sanofi

AstraZenecaAnnouncement

11/04/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230411:nRSK7193Va&default-theme=true

RNS Number : 7193V  AstraZeneca PLC  11 April 2023

11 April 2023 07:00 BST

 

Update to contractual arrangements between AstraZeneca, Swedish Orphan
Biovitrum AB and Sanofi

 

AstraZeneca, 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.

 

Notes

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
(https://www.astrazeneca.com/media-centre/press-releases/2017/medimmune-and-sanofi-pasteur-form-alliance-to-develop-and-commercialise-potential-next-generation-respiratory-syncytial-virus-antibody-medi8897-030317.html#modal-historic-confirmation)
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
(https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-to-divest-us-synagis-rights-to-sobi131120180.html)
, 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).

 

Today's announcement is made pursuant to LR10.4.2 R in respect of the November
2018 announcement. Except as set out in this announcement, there has been no
significant change affecting any matter contained in the 2018 announcement and
no other significant new matter has arisen which would have been required to
be mentioned in the 2018 announcement if it had arisen at the time of the
preparation of the 2018 announcement.

 

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.    Centers for Disease Control and Prevention. Vaccines &
Immunizations. August 18, 2017.
https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed April 2023.

2.    European Commission.
https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_en.pdf.
Accessed April 2023.

3.    Medicines & Healthcare products Regulatory Agency.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1119040/Marketing_authorisations_granted_1_-_14_November_2022.pdf.
Accessed April 2023.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDGPUQWCUPWGBU