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AstraZeneca, Ionis sign agreement to develop and commercialise eplontersen
DTMT Network
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals, for experimental drug eplontersen, which is currently under Phase III clinical trials for treating amyloid transthyretin cardiomyopathy (ATTR-CM), where the heart muscles stiffen and interfere with its blood pumping capacity, and amyloid transthyretin polyneuropathy, a general degeneration of peripheral nerves that spreads towards the centre of the body (ATTR-PN), an official statement released by the company said.
AstraZeneca will pay Ionis an upfront payment of $200m and 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 statement added.
The drug is designed to reduce the production of the transthyretin (TTR protein) to treat both hereditary and non-hereditary forms of TTR amyloidosis (ATTR), it added.
According to the terms of the agreement, the companies will jointly develop and commercialise eplontersen in the United States, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.
Various studies indicate that amyloid transthyretin cardiomyopathy is a progressive and fatal condition that leads to gradual heart failure and death within four years from diagnosis and its prevalence is thought to be underestimated.
“Eplontersen has the potential to halt the progression of TTR-mediated amyloidosis, irrespective of whether it’s caused by genetic mutations or ageing,” Mene Pangalos, the executive vice president in charge of R&D in AstraZeneca, said.
“Thanks to its precise liver-targeting properties, it also has the potential to be a best-in-class treatment for patients suffering from this devastating disease and who currently have limited options,” he added.
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 United States Food and Drug Administration by the end of 2022, the statement informed.
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