Royalty Pharma, Agios enter into vorasidenib royalty agreement

Royalty Pharma (RPRX) has acquired an interest in Agios Pharmaceuticals’ (AGIO) royalty on Servier’s vorasidenib for $905 million in upfront cash contingent on U.S. Food and Drug Administration approval of vorasidenib. Vorasidenib is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 enzymes for the treatment of IDH-mutant diffuse glioma. Low grade IDH-mutant diffuse gliomas have an incidence of approximately 1,500 patients per year and a prevalence of approximately 10,000 in the U.S. according to Royalty Pharma estimates. The pivotal Phase 3 INDIGO clinical trial for vorasidenib met its primary endpoint with a clinically meaningful extension of progression-free survival and the key secondary endpoint of time to next intervention. Vorasidenib was granted Breakthrough Therapy Designation by the FDA, and it received priority review with a Prescription Drug User Fee Act action date of August 20, 2024. Under the terms of the agreement, Royalty Pharma will pay Agios $905 million in upfront cash on FDA approval of vorasidenib in exchange for a 15% royalty on annual U.S. net sales of vorasidenib up to $1 billion and a 12% royalty on annual U.S. net sales greater than $1 billion. Agios will retain a 3% royalty on annual U.S. net sales greater than $1 billion. Royalty Pharma projects greater than $1 billion in peak annual sales potential for vorasidenib, which is expected to generate royalties of greater than $150 million annually to Royalty Pharma. If approved, Royalty Pharma anticipates vorasidenib will generate royalties through 2038.