- Apellis Pharmaceuticals (APLS, Financial) enters a $300 million royalty agreement with Sobi for Aspaveli.
- The agreement features a $275 million upfront cash infusion and up to $25 million in milestone payments.
- Apellis retains exclusive U.S. commercialization rights amid ongoing regulatory reviews for new indications.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) has signed a significant royalty purchase agreement with Sobi® valued at up to $300 million for Aspaveli® (systemic pegcetacoplan). The deal consists of a $275 million upfront payment and potential milestone payments of up to $25 million, contingent upon EMA approval for C3G and IC-MPGN indications.
Under the terms of the agreement, Sobi will acquire 90% of Apellis' ex-U.S. royalties for Aspaveli, with royalties ranging from high teens to high twenties. Apellis will maintain exclusive U.S. commercialization rights, where Aspaveli is marketed as EMPAVELI®, and retains 10% of ex-U.S. royalties during defined performance periods. After performance-based caps are met, all ex-U.S. royalties will revert to Apellis.
Currently, Aspaveli/EMPAVELI is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the EU, U.S., and other countries. The drug is under regulatory review for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), with an expected opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) by year-end 2025 and a U.S. FDA Prescription Drug User Fee Act (PDUFA) action date set for July 28, 2025.