Core Insights - Vorasidenib, if approved, would be the first targeted therapy for IDH-mutant glioma, a progressive and incurable brain tumor [1][2] - The pivotal Phase 3 clinical study of vorasidenib showed unprecedented efficacy and tolerability, meeting its primary endpoint of progression-free survival [2][4] - Royalty Pharma has acquired an interest in Agios Pharmaceuticals' royalty on vorasidenib for $905 million, contingent on FDA approval [1][3] Financial Projections - Royalty Pharma projects peak annual sales for vorasidenib to exceed $1 billion in the U.S., with potential royalties exceeding $150 million annually [1][4] - Under the agreement, Royalty Pharma will pay Agios $905 million upfront upon FDA approval, receiving a 15% royalty on U.S. net sales up to $1 billion and a 12% royalty on sales exceeding that amount [3] Market Context - Vorasidenib targets IDH-mutant diffuse gliomas, which have an incidence of approximately 1,500 patients per year and a prevalence of around 10,000 in the U.S. [2] - The drug has received Breakthrough Therapy Designation from the FDA and is under priority review, with a PDUFA date set for August 20, 2024 [2][4]
Royalty Pharma and Agios Pharmaceuticals Enter Into Vorasidenib Royalty Agreement for $905 Million