RPRX - Royalty Pharma and Agios Pharmaceuticals Enter Into Vorasidenib Royalty Agreement for $905 Million | Benzinga
- Vorasidenib, if approved, would be the first targeted therapy in IDH-mutant glioma, a progressive and incurable brain tumor
- Pivotal Phase 3 clinical study of vorasidenib demonstrated unprecedented efficacy and tolerability; vorasidenib granted priority review with PDUFA date of August 20, 2024
- Royalty Pharma projects greater than $1 billion in peak sales annually for vorasidenib in the U.S.; potential to generate royalties exceeding $150 million annually
- Royalty Pharma to host investor call today, Tuesday, May 28 at 8:30am EDT
NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) today announced that it has acquired an interest in Agios Pharmaceuticals' royalty on Servier's vorasidenib for $905 million in upfront cash contingent on U.S. Food and Drug Administration (FDA) approval of vorasidenib.
"We are excited to acquire royalties on vorasidenib, which if approved, would be the first targeted therapy for patients with IDH-mutant glioma," said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. "Innovation has been lacking in glioma treatment for over two decades, and we believe vorasidenib, which demonstrated unprecedented efficacy with a well-tolerated safety profile in its pivotal clinical study, is a potentially transformative therapy. We look forward to its upcoming PDUFA date and are excited for IDH-mutant diffuse glioma patients to potentially have a new treatment option."
Vorasidenib is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) 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 (PDUFA) 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 ...