- 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 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.
Royalty Pharma projects greater than $1 billion in peak annual sales potential for vorasidenib, which is expected to generate royalties of greater than $150 million annually to Royalty Pharma. If approved, Royalty Pharma anticipates vorasidenib will generate royalties through 2038.
Conference Call Information
Royalty Pharma will host a conference call and simultaneous webcast to discuss the transaction today, Tuesday, May 28th at 8:30 a.m. Eastern Time. Please visit the “Investors” page of the company’s website at https://www.royaltypharma.com/investors/events/ to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.
Advisors
Goodwin Procter LLP and Fenwick & West LLP acted as legal advisors to Royalty Pharma.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly - directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT, Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s Trodelvy, and 17 development-stage product candidates.
Royalty Pharma Forward-Looking Statements
The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof.
This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
Certain information contained in this document relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company's own internal estimates and research. While the company believes these third-party sources to be reliable as of the date of this document, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this document involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the company believes its own internal research is reliable, such research has not been verified by any independent source.
For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.
Royalty Pharma Investor Relations and Communications
+1 (212) 883-6772
ir@royaltypharma.com
