In early 2020, FibroGen’s expectations were high for the anemia drug roxadustat when Enrique Conterno became the company’s new CEO. Conterno’s impressive track record from his 27-year tenure at Eli Lilly, along with his belief in the significant commercial potential of roxadustat, had raised hopes for the drug’s success, as noted by analysts at the time.
However, in the following years, FibroGen and AstraZeneca faced a series of challenges. Roxadustat encountered an FDA rejection, commercial setbacks, and a setback in a clinical trial, all of which significantly affected the drug’s trajectory as an oral anemia medication.
Amid these difficulties and a major round of layoffs, Conterno, who had been serving as FibroGen’s CEO since January 2020, decided to step down for “personal reasons,” as announced by the company on Tuesday. Thane Wettig, the company’s chief commercial officer, will take on the role of interim CEO while FibroGen searches for a permanent replacement. Conterno will assist Wettig as a special advisor during the transition period.
The departure of Conterno followed closely after FibroGen’s announcement of a cost-cutting plan, involving laying off 104 employees, which accounted for 32% of its workforce. The decision was made in response to disappointing results from two phase 3 trials of pamrevlumab, another potential blockbuster candidate, in addition to the multiple setbacks faced by roxadustat.
China has been a notable success for FibroGen and roxadustat, as evidenced by the rapidly growing roxadustat business in China and other territories. Conterno and Chairman Schoeneck both acknowledged Conterno’s contribution in driving late-stage clinical execution and roxadustat’s commercial success in China.
On the financial front, Evrenzo (roxadustat) generated $64.1 million in China during the first quarter of 2023, up from $43.5 million in the same period in 2022. However, the drug faced challenges in Japan and Europe, where FibroGen’s partner Astellas recorded a substantial impairment charge due to disappointing sales projections.
In the United States, roxadustat encountered difficulties with safety concerns, leading to disruptions in plans for FDA approval in chronic kidney disease (CKD) patients in 2021. Additionally, a phase 3 study in anemia patients with myelodysplastic syndromes (MDS) also resulted in failure, posing a significant threat to FibroGen’s partnership with AstraZeneca in the U.S. The inability to agree on funding for a new trial to support another CKD filing further complicated matters.