a8637w
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 December 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca and
Ionis close eplontersen deal
29 December 2021 07:00 GMT
AstraZeneca and Ionis close agreement to develop
and commercialise eplontersen
AstraZeneca has closed a global
development and commercialisation agreement with Ionis
Pharmaceuticals, Inc. (Ionis) for
eplontersen, formerly
known as IONIS-TTR-LRX.
The companies will jointly develop and commercialise eplontersen in
the US, while AstraZeneca will develop and commercialise it in the
rest of the world, except in Latin America.
Financial considerations
Under the terms of the agreement, the upfront payment from
AstraZeneca to Ionis is $200m. AstraZeneca will make additional
conditional payments of up to $485m following regulatory approvals.
It will also pay up to $2.9bn of sales-related milestones based on
sales thresholds between $500m and $6bn, plus royalties in the
range of low double-digit to mid-twenties percentage depending on
the region. The collaboration includes territory-specific
development, commercial and medical affairs cost-sharing
provisions.
The transaction will be funded with cash and is expected to be
neutral to Core earnings in 2021. It will be accounted for as an
intangible asset acquisition, recognised initially at the upfront
amount, with any potential future milestone payments capitalised
into the intangible asset as they are recognised.
Ionis will continue to manufacture and supply eplontersen for the
existing clinical studies and process qualification. AstraZeneca
will be responsible for commercial supply, with transition timing
to be agreed by both parties. AstraZeneca will book all sales
generated under the agreement.
The transaction does not impact AstraZeneca's financial guidance
for 2021.
Notes
Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA) investigational
medicine designed to reduce the production of transthyretin, or TTR
protein, to treat all types of TTR amyloidosis (ATTR), a systemic,
progressive and fatal disease.
TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by aging
or genetic mutations resulting in misfolded TTR protein and
accumulation as amyloid fibrils in the cardiac myocardium and
peripheral nerves, respectively. In patients with ATTR, both the
mutant and wild type TTR protein builds up as fibrils in tissues,
such as the peripheral nerves, heart, gastrointestinal system,
eyes, kidneys, central nervous system, thyroid and bone marrow. The
presence of TTR fibrils interferes with the normal functions of
these tissues. As the TTR protein fibrils enlarge, more tissue
damage occurs and the disease worsens, resulting in poor quality of
life and eventually death. Worldwide, there are an estimated
300,000 - 500,000 patients with amyloid transthyretin
cardiomyopathy (ATTR-CM)1,2 and
10,000 - 40,000 patients with amyloid transthyretin polyneuropathy
(ATTR-PN).3
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.
Mohamed-Salem L, et al. Prevalence of wild type ATTR assessed as
myocardial uptake in bone scan in the elderly
population. Int J
Cardiol. 2018 Nov
1;270:192-196. doi:
10.1016/j.ijcard.2018.06.006.
2.
Cuscaden C, et al. Estimation of prevalence of transthyretin (ATTR)
cardiac amyloidosis in an Australian subpopulation using bone scans
with echocardiography and clinical
correlation. J Nucl
Cardiol. 2020 May 8. doi:
10.1007/s12350-020-02152-x.
3.
González-Duarte A, et al. Impact of non-cardiac clinicopathologic
characteristics on survival in transthyretin amyloid
polyneuropathy. Neurol Ther. 2020;9(1):135-149.
doi:10.1007/s40120-020-00183-7.
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:
29 December 2021
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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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