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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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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