Longtime Intercept CEO Mark Pruzanski departs as ailing NASH company tries to find its future
Mark Pruzanski, the CEO who turned “NASH” into a household name around biotech, guided his company to the precipice of a nascent field and then watched it falter in the wake of a CRL, will step down on January.
Intercept Pharmaceuticals announced Tuesday that Pruzanski, who has led the biotech since its founding, will be replaced by Jerome Durso, a longtime Sanofi executive and the COO of Intercept since 2017. Durso will take the reins of a company facing a difficult road forward, as the company tries to convince the FDA to rethink its decision to reject their lead drug for NASH, cutting the stock and forcing layoffs.
Pruzanski will stay on as a board member.
“This is a pivotal time for the company as we advance our foundational rare liver disease business and work towards the potential resubmission of our NDA in NASH fibrosis,” Durso said in a statement. “I am confident that we will leverage our core strengths and capabilities across the business to execute on plans for continued growth and advancement of our pipeline to drive the future success of Intercept.”
Pruzanski, then a young venture capitalist at Apple Tree Partners, founded Intercept in 2002 with the Italian doctor Roberto Pellicciari, who had synthesized molecules that could be used as liver drugs. After years of early development, he has led the company through a decade of ups and downs. At JPM 2014, two years after going public, the company announced positive Phase II results in NASH, a little-known fatty liver disease estimated to affect millions of Americans.
Many investors had never heard of NASH, but within hours, the company’s shares more than tripled, adding $4 billion in market value and helping spur a half-decade of investment into the field.
The road ahead, though, was rockier. Pruzanski soon said they would likely need a partner to bring the drug to market — a not unusual announcement for a small biotech but one that dispirited investors. Then in 2017, the company’s NASH compound, which had been approved for a different condition, was linked to 19 deaths. Pruzanski downplayed it, saying doctors would learn how to better prescribe it.
Last year, Intercept announced much-anticipated Phase III results for the NASH drug. The company touted it as a success but the results were mixed: The company showed the drug improved liver fibrosis but failed to show that it resolved NASH. In June, after several delays, the FDA rejected the company’s approval request.
Pruzanski issued a strongly worded statement, accusing the FDA of unfairly raising the bar for approval and for conducting an “apparently incomplete review.”
“At no point during the review did the FDA communicate that OCA was not approvable on an accelerated basis,” he said.
Another blow came in the fall, after the FDA flagged more potential safety issues with the drug. Intercept only disclosed the drug on the 57th page of a quarterly report, in three sentences added to a pre-existing risk-statement paragraph.
Intercept and its new CEO now find itself in a similar position to much of the NASH field, which has seen multiple late-stage trial failures and persistent setbacks. The FDA has asked the company for more safety and efficacy data.