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.
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based on studies, publications, surveys and other data obtained
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For further information, please reference Royalty Pharma’s
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the SEC website at www.sec.gov.
Royalty Pharma Investor Relations and
Communications
+1 (212) 883-6772ir@royaltypharma.com
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