AstraZeneca PLC AstraZeneca and Ionis close eplontersen deal (8221W)
December 29 2021 - 1:00AM
UK Regulatory
TIDMAZN
RNS Number : 8221W
AstraZeneca PLC
29 December 2021
29 December 2021 07:00 GMT
AstraZeneca and Ionis close agreement to develop
and commercialise eplontersen
AstraZeneca has closed a global development and
commercialisation agreement with Ionis Pharmaceuticals, Inc.
(Ionis) for eplontersen, formerly known as IONIS-TTR-L(RX.)
The companies will jointly develop and commercialise eplontersen
in the US, while AstraZeneca will develop and commercialise it in
the rest of the world, except in Latin America.
Financial considerations
Under the terms of the agreement, the upfront payment from
AstraZeneca to Ionis is $200m. AstraZeneca will make additional
conditional payments of up to $485m following regulatory approvals.
It will also pay up to $2.9bn of sales-related milestones based on
sales thresholds between $500m and $6bn, plus royalties in the
range of low double-digit to mid-twenties percentage depending on
the region. The collaboration includes territory-specific
development, commercial and medical affairs cost-sharing
provisions.
The transaction will be funded with cash and is expected to be
neutral to Core earnings in 2021. It will be accounted for as an
intangible asset acquisition, recognised initially at the upfront
amount, with any potential future milestone payments capitalised
into the intangible asset as they are recognised.
Ionis will continue to manufacture and supply eplontersen for
the existing clinical studies and process qualification.
AstraZeneca will be responsible for commercial supply, with
transition timing to be agreed by both parties. AstraZeneca will
book all sales generated under the agreement.
The transaction does not impact AstraZeneca's financial guidance
for 2021.
Notes
Eplontersen
Eplontersen is a ligand-conjugated antisense (LICA)
investigational medicine designed to reduce the production of
transthyretin, or TTR protein, to treat all types of TTR
amyloidosis (ATTR), a systemic, progressive and fatal disease.
TTR Amyloidosis (ATTR)
Cardiomyopathy and polyneuropathy due to ATTR are caused by
aging or genetic mutations resulting in misfolded TTR protein and
accumulation as amyloid fibrils in the cardiac myocardium and
peripheral nerves, respectively. In patients with ATTR, both the
mutant and wild type TTR protein builds up as fibrils in tissues,
such as the peripheral nerves, heart, gastrointestinal system,
eyes, kidneys, central nervous system, thyroid and bone marrow. 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 amyloid transthyretin
cardiomyopathy (ATTR-CM)(1,2) and 10,000 - 40,000 patients with
amyloid transthyretin polyneuropathy (ATTR-PN).(3)
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. 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.
2. 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.
3. 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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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