US-based biopharmaceutical company FibroGen Inc., (NASDAQ: FGEN) has released its financial report for the second quarter of 2023, featuring record new highs for sales of the first-in-class HIF prolyl-hydroxylase inhibitor, Evrenzo (roxadustat), in China. Total net sales of Evrenzo in China, including through a joint venture with AstraZeneca, reached USD 76.4 million, marking a 44% year-on-year (YOY) increase, driven by a 40% rise in usage volume. The drug maintains its leading market share as a treatment for anemia associated with chronic kidney disease in China.
European Launch and Ongoing Development of Evrenzo
The launch of Evrenzo in Europe is progressing, with the company reporting “robust quarter-over-quarter growth,” although specific details were not disclosed. Development of roxadustat for new indications continues, despite a setback in a Phase III study for anemia in patients with transfusion-dependent lower risk myelodysplastic syndrome, where the molecule failed to meet endpoints. However, positive data emerged for the drug’s use in treating anemia in patients receiving concurrent chemotherapy for non-myeloid malignancies in China. A supplemental new drug application has been filed in China for roxadustat in patients with chemotherapy-induced anemia, with approval expected by mid-2024.
Interim CEO’s Outlook and Revenue Potential
Interim CEO Thane Wettig, during the earnings conference call, noted the potential for this new indication to represent a significant incremental net revenue opportunity, suggesting a pathway for roxadustat to achieve over USD 500 million in annual net sales in China.
Challenges and Pipeline Updates
Besides the success of roxadustat, FibroGen has faced a challenging period with its lead pipeline candidate, pamrevlumab, failing two Phase III trials during the quarter—one for idiopathic pulmonary fibrosis (IPF) and the other for non-ambulatory Duchenne Muscular Dystrophy (DMD). Pamrevlumab, a potential first-in-class antibody targeting connective tissue growth factor (CTGF), is linked to fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Development for IPF has been discontinued, but FibroGen retains hope for positive results from a Phase III trial in ambulatory DMD in Q3 2023 and topline results from another Phase III in pancreatic cancer expected in H1 2024.
Cost-Saving Measures and Leadership Changes
In response to these setbacks, FibroGen has reduced its US workforce by 32% to ensure cost savings. Additionally, CEO Enrique Conterno stepped down for personal reasons in July, with Thane Wettig taking over as the interim replacement.-Fineline Info & Tech
