- RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia
- Transaction increases Royalty Pharma's synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality
RYTELO was approved by the U.S. Food and Drug Administration in June 2024 for the treatment of certain adult patients with low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent (TD) anemia. Additionally, The National Comprehensive Cancer Network (NCCN) Guidelines were updated to include imetelstat as a Category 1 and 2A treatment of symptomatic anemia in patients with LR-MDS. Geron is currently enrolling a Phase 3 trial of imetelstat in myelofibrosis patients who are relapsed/refractory to JAK-inhibitors.
"RYTELO is an important therapy for the lower-risk MDS patient population, who otherwise have limited treatment options, and we look forward to its development in other hematologic malignancy indications. We are delighted to establish this partnership with Geron to help fuel their execution of significant commercial and development opportunities ahead” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma.
"The significant financial commitment from an exceptional long-term partner like Royalty Pharma strengthens our cash position and further solidifies our balance sheet, while providing flexibility to invest in our future” said John Scarlett, Geron's President and Chief Executive Officer. "We believe that the terms reflect the significant commercial potential of RYTELO.”
Royalty Pharma has provided $125 million at closing and will receive tiered royalty payments on U.S. net sales of RYTELO, ranging from 7.75% of annual net sales up to $500 million, 3.0% of annual net sales between $500 million and $1 billion, and 1.0% of annual net sales over $1 billion. Payments to Royalty Pharma will cease if the aggregate royalties payable through June 30, 2031 reach a multiple of 1.65 its investment, otherwise the royalty payments will continue until Royalty Pharma receives a multiple of 2.0 its investment.
Advisors
TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Geron. Goodwin Procter and Fenwick & West LLP served 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, GSK's Trelegy, Roche's Evrysdi, Johnson & Johnson's Tremfya, Biogen's Tysabri and Spinraza, AbbVie and Johnson & Johnson's Imbruvica, Astellas and Pfizer's Xtandi, Novartis' Promacta, Pfizer's Nurtec ODT and Gilead's Trodelvy, and 15 development-stage product candidates.
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