Caption: Royalty Pharma projects more than $1bn in annual peak sales for vorasidenib. Image credit: Shutterstock/ ADragan.

As Servier’s day of reckoning with US Food and Drug Administration (FDA) approaches for vorasidenib, Agios – which owns royalties on drug’s US sales – has agreed to part with its stake in the drug for $905m.

US-based Royalty Pharma is the purchaser, receiving 15% royalty on annual US net sales of vorasidenib for up to $1bn. The deal is contingent on vorasidenib being approved by the FDA – the Prescription Drug User Fee Act (PDUFA) action date is set for August 20, 2024.

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According to the terms of the deal, Royalty Pharma will also gain 12% royalty on annual US sales over $1bn, as per a 28 May press release.

Vorasidenib is a hotly anticipated drug in the oncology space. The candidate, which was granted breakthrough therapy designation and priority review by the FDA, is indicated for IDH-mutant diffuse glioma treatment, a type of brain cancer. The orally administered drug can cross the blood-brain barrier and inhibits two enzymes that are mutated in glioma patients.

French drugmaker Servier gained control of vorasidenib after buying Agios’ oncology pipeline for $1.8bn in 2020. At the time, vorasidenib was in a Phase III trial for IDH-mutant low-grade glioma treatment. Despite selling rights to the drug, Agios kept the royalties and agreed to receive a $200m regulatory milestone-related payment.

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If approved, vorasidenib could well be on its way to blockbuster status, according to Royalty Pharma. The company projects more than $1bn in annual peak sales for vorasidenib, giving the company $150m annually in royalties. Royalty Pharma expects to generate royalties until 2038.

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The deal adds to a string of recent big purchases by Royalty Pharma. Earlier this month, the company paid $525m to ImmuNext to gain access to milestone-based and royalty payments to frexalimab, which is licensed to Sanofi.

Last week, the company poured $575m into biopharma Cytokinetics as the latter aims to take on Bristol Myers Squibb in the hypertrophic cardiomyopathy space. Back in October last year, Royalty Pharma acquired royalty rights from PTC Therapeutics for its spinal muscular atrophy medicine Evrysdi (risdiplam) co-developed with Roche in a $1.5bn deal.

As for Agios, CEO Brian Goff said the funds raised will go towards a potential launch for Pyrukynd (mitapivat) in thalassemia and sickle cell disease.