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Tuesday, Agios Pharmaceuticals Inc (NASDAQ:AGIO) agreed to sell its rights to its 15% royalty on potential U.S. net sales of Servier’s vorasidenib to Royalty Pharma Plc (NASDAQ:RPRX).
Under the terms of the agreement, Agios will receive an upfront payment of $905 million upon FDA approval of vorasidenib, 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 over $1 billion.
Vorasidenib is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for IDH-mutant diffuse glioma.
IDH mutant gliomas are the most common adult, malignant primary brain tumors diagnosed in patients younger than 50.
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 and 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.
Earlier this year, Agios Pharmaceuticals said the Phase 3 ENERGIZE study of mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia achieved its primary endpoint of hemoglobin response.
Statistical significance was also achieved for both key secondary endpoints associated with a change from baseline in FACIT-Fatigue Score and hemoglobin concentration.
Price Action: AGIO shares are up 20.7% at $38.03 at last check Tuesday.
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