FibroGen Regains All Rights to Roxadustat from AstraZeneca in the United States and Other AstraZeneca Territories, Except China and South Korea

The FibroGen – AstraZeneca China Agreement for Roxadustat remains in place

FibroGen to explore licensing opportunities for Roxadustat

SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category. In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.

“We continue to believe that roxadustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved,” said Thane Wettig, FibroGen Chief Executive Officer. “Based on the data presented at ASH 2023 investigating roxadustat for the treatment of anemia in patients with higher transfusion burden low-risk-MDS, we will be evaluating opportunities to bring this innovative medicine to patients through outreach to companies that may be interested in a product opportunity to address a disease with significant unmet need and attractive commercial potential.”

About Roxadustat
Roxadustat is an oral HIF-PH inhibitor that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, by improving iron absorption and mobilization and downregulation of hepcidin. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on-dialysis and not on-dialysis. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China. Roxadustat is in clinical development for chemotherapy-induced anemia and a Supplemental New Drug Application has been accepted by the China Health Authority. Several other licensing applications for roxadustat have been submitted by partners to regulatory authorities across the globe. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.