Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
11 Abril 2023 - 7:42AM
Edgar (US Regulatory)
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April
2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update to arrangements with Sobi and Sanofi
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 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).
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 and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
11 April 2023
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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