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AstraZeneca, Ionis In Deal To Develop And Commercialise Eplontersen - Quick Facts

AstraZeneca Plc. (AZN.L,AZN) Tuesday said it has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. for eplontersen, formerly known as IONIS-TTR-LRX.

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.

AstraZeneca will pay Ionis an upfront payment of $200 million and additional conditional payments of up to $485 million following regulatory approvals. It will also pay up to $2.9 billion of sales-related milestones based on sales thresholds between $500 million and $6 billion, 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 is expected to close in the fourth quarter of 2021, subject to customary closing conditions and regulatory clearances. The deal is now expected to impact the AstraZeneca's financial guidance for 2021.

The company said the agreement will be funded with cash and is expected to be neutral to Core earnings in 2021.

Eplontersen is a ligand-conjugated antisense investigational medicine currently in Phase III clinical trials for amyloid t ransthyretin cardiomyopathy or ATTR-CM and amyloid t ransthyretin polyneuropathy or ATTR-PN. It is designed to reduce the production of transthyretin or TTR protein to treat both hereditary and non-hereditary forms of TTR amyloidosis.

ATTR-CM is a systemic, progressive and fatal condition that leads to progressive heart failure and death within four years from diagnosis. Hereditary ATTR-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade.

Hereditary ATTR-PN is expected to be the first indication for which the companies will seek regulatory approval for eplontersen, with the potential to file a new drug application with the US Food and Drug Administration by the end of 2022.

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.

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