Agios Pharmaceuticals, Inc., renowned for its work in cellular metabolism and PK activation, has entered into an agreement to sell its rights to a potential 15% royalty on U.S. net sales of the drug vorasidenib to Royalty Pharma. This deal could yield Agios an upfront payment of $905 million upon the FDA's approval of vorasidenib. The drug, an oral inhibitor aimed at treating IDH-mutant diffuse glioma, was part of Agios' oncology portfolio, which was sold to Servier in 2021.
Under the terms of the agreement, Royalty Pharma will receive the 15% royalty on U.S. net sales of vorasidenib up to $1 billion and 12% on any sales exceeding that amount. Agios will retain a 3% royalty on sales that exceed the $1 billion mark. Additionally, Agios is entitled to a milestone payment of $200 million from Servier once the FDA approves vorasidenib. As a result, Agios stands to gain a total of $1.1 billion upon the drug's approval. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s decision has been set for August 20, 2024.
Brian Goff, CEO of Agios, expressed enthusiasm about the agreement, highlighting that it brings significant financial flexibility while maintaining long-term value. He noted that the deal aligns with Agios' strategic plans, such as preparing for the potential launches of PYRUKYND® (mitapivat) for thalassemia and sickle cell disease. This transaction is expected to support the company’s aim to build a franchise around PK activation therapies and expand its pipeline with both internally and externally discovered assets.
Goldman Sachs & Co. LLC acted as the exclusive financial advisor for Agios, with WilmerHale serving as the legal advisor.
Agios Pharmaceuticals remains a pioneering entity in the field of PK activation, focusing on developing transformative therapies for rare diseases. The company markets a first-in-class pyruvate kinase activator for adults with PK deficiency, a rare and debilitating form of hemolytic anemia. Agios is also advancing a strong clinical pipeline, with programs targeting alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency, MDS-associated anemia, and phenylketonuria (PKU). Furthermore, Agios is working on a preclinical TMPRSS6 siRNA as a possible treatment for polycythemia vera.
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