REG - AstraZeneca PLC - AstraZeneca and Neurimmune close deal for NI006

AstraZenecaAnnouncement

01/03/2022 07:00

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RNS Number : 1131D  AstraZeneca PLC  01 March 2022

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
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-and-neurimmune-sign-deal-for-ni006.html)
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-CM(5,6);
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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

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

 

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