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 March 2022
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
AstraZeneca and Neurimmune close deal for
NI006
01
March 2022 07:00 GMT
AstraZeneca and Neurimmune close exclusive global collaboration and
licence agreement to develop and commercialise NI006
Alexion, AstraZeneca's Rare Disease group, has
closed an exclusive global collaboration
and licence agreement with
Neurimmune AG for NI006, an investigational human monoclonal
antibody currently in Phase Ib development for the treatment of
transthyretin amyloid cardiomyopathy (ATTR-CM),
an underdiagnosed, systemic condition that leads to
progressive heart failure and high rate of fatality within four
years from diagnosis.1,2
Alexion
has been granted an exclusive worldwide licence to develop,
manufacture and commercialise NI006.
NI006
is an ATTR depleter that specifically targets tissue-deposited,
misfolded transthyretin, with the potential to treat patients with
advanced ATTR-CM. NI006 adds a novel and complementary approach to
AstraZeneca and Alexion's pipeline of investigational therapies
focused on amyloidosis and strengthens the Company's broader
commitment to addressing cardiomyopathies that can lead to heart
failure (HF).
Financial considerations
Under
the terms of the agreement, the upfront payment from Alexion to
Neurimmune is $30m. Alexion will make additional contingent
milestone payments of up to $730m upon achievement of certain
development, regulatory and commercial milestones. It will also pay
low-to-mid teen royalties on net sales of any approved medicine
resulting from the collaboration.
Neurimmune
will continue to be responsible for completion of the current Phase
Ib clinical trial on behalf of Alexion, and Alexion will pay
certain trial costs. Alexion will be responsible for further
clinical development, manufacturing and commercialisation following
the Phase Ib trial.
Notes
Heart failure
HF is a life-threatening chronic disease that
prevents the heart from pumping sufficient levels of blood around
the body. HF affects approximately 64 million people worldwide. HF
remains as fatal as some of the most common cancers in both men
(prostate and bladder cancers) and women (breast
cancer).3 Chronic
HF is the leading cause of hospitalisation for those over the age
of 65 and represents a significant clinical and economic
burden.4
AstraZeneca's
ambition is to be the leading company in HF. AstraZeneca is
investing in multiple investigational therapies with diverse
mechanisms of action to address the spectrum of patient need in
this area.
ATTR-CM
Cardiomyopathy
due to ATTR is caused by aging or genetic mutations resulting in
misfolded TTR protein and accumulation as amyloid fibrils in the
cardiac myocardium. In patients with ATTR-CM, both the mutant and
wild type TTR protein builds up as fibrils in tissues, including
the heart. 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 ATTR-CM5,6;
however, many of those patients remain
undiagnosed.
NI006
NI006
is an investigational human monoclonal antibody that specifically
targets misfolded transthyretin and is designed to directly address
the pathology of ATTR-CM by enabling removal of amyloid fibril
deposits in the heart, with the potential to treat patients with
advanced ATTR-CM.
Alexion
Alexion,
AstraZeneca Rare Disease, is the group within AstraZeneca focused
on rare diseases, created following the 2021 acquisition of Alexion
Pharmaceuticals, Inc. As a leader in rare diseases for nearly 30
years, Alexion is focused on serving patients and families affected
by rare diseases and devastating conditions through the discovery,
development and commercialisation of life-changing medicines.
Alexion focuses its research efforts on novel molecules and targets
in the complement cascade and its development efforts on
haematology, nephrology, neurology, metabolic disorders, cardiology
and ophthalmology. Headquartered in Boston, Massachusetts, Alexion
has offices around the globe and serves patients in more than 50
countries.
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.
Lauppe RE, et al. Nationwide prevalence and characteristics of
transthyretin amyloid cardiomyopathy in Sweden. Open Heart. 2021
Oct;8(2):e001755. doi: 10.1136/openhrt-2021-001755.
2.
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.
3.
Mamas MA et al. Do Patients Have Worse Outcomes in Heart Failure
than in Cancer? A Primary Care-Based Cohort Study with 10-year
Follow-up in Scotland. Eur J Heart Fail 2017;
19(9):1095-104.
4.
Azad N, Lemay G. Management of Chronic Heart Failure in the Older
Population. J Geriatr Cardiol 2014; 11(4):329-37.
5. 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.
6. 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.
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:
01 March 2022
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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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