REG - AstraZeneca PLC - AstraZeneca and Ionis close eplontersen deal

AstraZenecaAnnouncement

29/12/2021 07:00

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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
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-ionis-to-collaborate-on-eplontersen.html)
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 (https://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. 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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