After last year’s unexpected passing of founder and long-time helmsman Thomas Neff, FibroGen needed a permanent successor—and with its big roxadustat launch looming, that new CEO would ideally know the ropes in kidney and metabolic diseases.
Now, it's found a perfect candidate.
Enrique Conterno, who retired from Eli Lilly two months ago as its U.S. business chief and worldwide diabetes lead, has signed on as FibroGen’s new CEO, the biotech revealed Monday. Jim Schoeneck, interim CEO since August and a 10-year FibroGen board member, has moved to the chairman role.
“Following a comprehensive search, we are confident Enrique is the right individual to assume leadership of FibroGen at this pivotal time,” Tom Kearns, most recently FibroGen’s chairman and lead independent director, said in a statement.
The “pivotal time” refers to the global launch of first-in-class roxadustat in partnership with AstraZeneca in China and the U.S., and with Astellas Pharma in Japan and Europe. Pointing to Conterno’s 27-year experience at Lilly, Kearns described the new CEO as “extremely qualified” for the task.
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Conterno is credited with returning Lilly’s diabetes business to the industry's top spot, with annual revenue of more than $10 billion. During his tenure, Boehringer Ingelheim-shared SGLT2 drug Jardiance made diabetes treatment history by racking up the field’s first cardiovascular approval after showing it can cut heart-related death risks.
Now, Conterno’s FibroGen is looking to work similar regulatory magic with roxadustat—only the CV advantage wouldn't be a new indication, but a safety edge. FibroGen and its partners have already won approvals for the med in China and Japan—specifically for patients with anemia associated with chronic kidney disease—and its U.S. filing was submitted in December.
Traditional erythropoiesis-stimulating agents for kidney patients, such as Amgen and Johnson & Johnson’s Epogen/Procrit, carry cardiovascular side effects that limit their use. With roxadustat, FibroGen hopes it cut those CV risks compared with standard of care.
RELATED: AstraZeneca, FibroGen's roxadustat heart data dispel safety doubts—or most of them
Recent pooled analyses of roxadustat’s phase 3 programs showed that the new med is about as safe as placebo in terms of CV complications in nondialysis-dependent patients, even though there was a numeric trend against it.
Meanwhile, though, data in dialysis-dependent patients raised controversy. In that group, roxadustat only matched up to Epogen on the rate of major adverse CV events, a marker the FDA uses for its evaluation. Because a subgroup of new dialysis patients taking roxadustat enjoyed much lower CV risks compared with those on Epogen, analysts have questioned whether the remaining patients already stabilized on standard of care might have suffered more CV problems. If so, that might hurt its case before the FDA.
At least Conterno doesn’t have to worry much about the Chinese market; the drug already won go-aheads in both dialysis and nondialysis patients and has been added to the country’s national drug reimbursement list. What’s more, its partner AstraZeneca is a seasoned marketer there with a track record of successful drug launches.
Meanwhile, roxadustat is also in late-stage development for anemia associated with myelodysplastic syndromes and in a phase 2 U.S. trial for chemo-induced anemia. Another pipeline drug, pamrevlumab, is in phase 3 testing for idiopathic pulmonary fibrosis and pancreatic cancer, as well as in phase 2 in Duchenne muscular dystrophy.