On May 28, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company has agreed to sell its rights to its 15% royalty on potential U.S. net sales of Servier’s vorasidenib to Royalty Pharma (Press release, Agios Pharmaceuticals, MAY 28, 2024, View Source [SID1234643724]). Under the terms of the agreement, Agios will receive an upfront payment of $905 million upon approval of vorasidenib by the U.S. Food and Drug Administration (FDA) and Royalty Pharma will receive the entirety of the 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.

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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. In 2021, Agios completed the sale of its oncology portfolio – including vorasidenib – to Servier. As part of that divestiture, Agios is owed a milestone payment of $200 million upon vorasidenib’s approval by the FDA, as well as a 15% royalty on U.S. net sales of vorasidenib. Agios continues to retain the right to the approval milestone from Servier. Servier announced that the FDA has designated a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024.

"It’s an exciting time at Agios with multiple near-term catalysts that we believe have the potential to make a meaningful difference in patients’ lives and create significant shareholder value. With this transaction, we have added significant financial flexibility while retaining long-term value and have identified a partner in Royalty Pharma that shares our excitement about the potential of vorasidenib," said Brian Goff, chief executive officer at Agios. "This transaction will provide us with the financial independence to prepare for potential PYRUKYND (mitapivat) launches in thalassemia and sickle cell disease as we build a PK activation franchise with multi-billion-dollar potential, and to opportunistically expand our pipeline through both internally and externally discovered assets."

Goldman Sachs & Co. LLC acted as exclusive financial advisor to Agios; WilmerHale served as legal advisor to Agios.