TIDMAZN
RNS Number : 7555X
AstraZeneca PLC
07 January 2022
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-CM(3,4) ; 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
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