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 January 2022
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.
AstraZeneca
and Neurimmune sign deal for NI006
07 January 2022 07:00 GMT
AstraZeneca and Neurimmune sign exclusive global collaboration and
licence agreement to develop and
commercialise NI006
Investigational human monoclonal antibody in Phase Ib development
for the treatment of transthyretin amyloid cardiomyopathy, a
systemic, progressive and fatal condition
Alexion, AstraZeneca's Rare Disease group, has entered into 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). NI006 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.
Under the agreement, Alexion will be granted an exclusive worldwide
licence to develop, manufacture and commercialise
NI006.
ATTR-CM is a systemic, progressive and fatal condition that leads
to progressive heart failure and high rate of fatality within four
years from diagnosis.1 It
remains underdiagnosed and its prevalence is thought to be
underestimated due to a lack of disease awareness and the
heterogeneity of symptoms.2
Marc Dunoyer, Chief Executive Officer, Alexion, said: "With 30
years of experience in developing medicines for people with rare
diseases, Alexion is uniquely positioned to advance innovative
science for small patient populations who are frequently
underdiagnosed. We look forward to applying this expertise to the
development of NI006, which is designed to clear cardiac amyloid
fibril deposits with the potential to improve cardiac function for
patients living with advanced ATTR-CM, who are currently
underserved by existing treatment options."
There is a significant unmet medical need for patients with various
types and levels of severity of amyloidosis that may require
multiple mechanisms of action to address those needs. NI006, an
ATTR depleter, adds a novel and complementary approach to
AstraZeneca and Alexion's pipeline of investigational therapies
focused on amyloidosis and strengthens our broader commitment to
addressing cardiomyopathies that can lead to heart
failure.
Financial considerations
Alexion will pay Neurimmune an upfront payment of $30m with the
potential for additional contingent milestone payments of up to
$730m upon achievement of certain development, regulatory and
commercial milestones, as well as 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.
The transaction is expected to close following satisfaction of
customary closing conditions and regulatory
clearances.
Notes
Heart failure
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).5 Chronic
HF is the leading cause of hospitalisation for those over the age
of 65 and represents a significant clinical and economic
burden.6
AstraZeneca's ambition is to be the leading company in HF,
expanding from Forxiga today in heart failure with reduced ejection
fraction (HFrEF), to the full HF spectrum including
cardiomyopathies. 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-CM3,4;
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.
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. 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.
4. 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.
5.
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.
6.
Azad N, Lemay G. Management of Chronic Heart Failure in the Older
Population. J Geriatr Cardiol 2014; 11(4):329-37.
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:
07 January 2022
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024
