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news.FibroGen (FGEN), a research-based biopharmaceutical company, announced that it has received a scheduled $120m non-contingent license payment from AstraZeneca under its collaboration agreements with AstraZeneca for roxadustat in the United States, China and certain other territories.
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In addition to this non-contingent license payment of $120.0 million, as previously announced, FibroGen received a $15.0 million milestone payment from AstraZeneca during the second quarter of 2015 in connection with the completion of long-term preclinical safety studies of roxadustat.
On a pro-forma basis, FibroGen expects to have approximately $410 million to $415 million of cash, cash equivalents, investments, and receivables on June 30, 2015 (unaudited).
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that acts by stimulating the body’s natural pathway of red blood cell production, or erythropoiesis.
Roxadustat is the first HIF-PHI to enter Phase 3 clinical development and represents a novel approach to the treatment of anemia in patients with chronic kidney disease (CKD), with the potential to address the considerable unmet medical need for an effective treatment for anemia that offers the convenience of oral administration and an improved safety profile as compared to current standards of care.
Roxadustat is currently in Phase 3 global development for the treatment of anemia in patients with chronic kidney disease (CKD) on dialysis and not on dialysis.
The global development program is being conducted by FibroGen and its partners, AstraZeneca and Astellas Pharma Inc. Approximately 8,000 CKD patients will be enrolled in 10 clinical trials. Regulatory filings are expected to be submitted in 2016 for China and in 2018 for the US.