FibroGen has agreed to pay $1.25 million to the Securities and Exchange Commission (SEC) to address allegations that the biopharma's former chief medical officer manipulated data for the anemia drug roxadustat.
The allegations have been on the SEC’s radar since 2021, around the time that FibroGen admitted that “post-hoc changes” had been made to how phase 3 data for the HIF-PH inhibitor were analyzed. At the time, the biopharma was gearing up for an approval decision for roxadustat, with the FDA ultimately deciding to reject the application.
Now, the SEC is alleging that between November 2019 and March 2021, FibroGen’s former chief medical officer Kin-Hung Peony Yu, M.D., “reverse engineered” the initial phase 3 results to show that roxadustat was superior to existing treatment epoetin alfa when in reality the data showed that the drug was “at best, comparable to the existing treatment.”
According to the SEC’s Sept. 10 litigation filed in the U.S. District Court for the Northern District of California, Yu—who left FibroGen in March 2021—applied post hoc stratification factors when analyzing the phase 3 findings back in 2019, which made the pooled cardiovascular safety data appear more impressive than the initial evaluation.
Yu is then “alleged to have made the false and misleading claims in a range of forums, including a high-profile industry presentation and accompanying press release, multiple SEC filings, an earnings call, and a published article in a leading industry journal,” the agency said.
During the earnings call in November 2019, Yu also claimed the FDA had “agreed to the statistical approach underlying those reported results when, in fact, FibroGen had never sought the FDA’s input on the post-hoc changes to the stratification factors,” according to the SEC's allegations.
In response to the litigation, FibroGen agreed to pay $1.25 million to the SEC over the coming year, according to a separate filing by the federal agency.
Fierce Biotech has reached out to FibroGen to comment on its decision to settle with the SEC.
It’s not the first time FibroGen’s former employees have caused the company trouble. The biopharma sued two former staffers in 2022 for allegedly pinching proprietary information and filing improper patents around HIF-PH inhibitors like roxadustat. Both sides agreed to withdraw their legal proceedings last year.
AstraZeneca has maintained a stake in roxadustat’s fortunes for more than a decade. Despite returning the rights to the HIF-PH inhibitor in the U.S. and certain other countries last year, the U.K.-based Big Pharma retained an interest in China and South Korea, where the drug is approved under the brand name Evrenzo. In February, AstraZeneca paid $160 million for FibroGen’s China business, granting the pharma regional rights to roxadustat.
While FibroGen still hasn’t clinched a U.S. approval for the drug, roxadustat is available in Europe, where it is marketed by Astellas.