Genfit Addresses Multiple Transition Issues With CEO Change
Executive Summary
Co-founder and CEO Mouney will turn over the reins to former GSK and Lilly exec Pascal Prigent in mid-September.
As Genfit SA prepares to shift from a clinical- to a commercial-stage company, Pascal Prigent was named the firm's new CEO on 2 September because he brings the right skill set to make the transition.
Prigent was recruited for the French biotech in May 2018, as executive VP of marketing and commercial development. His prior experience in marketing, sales and management at GlaxoSmithKline PLC and before that at Eli Lilly & Co. was seen as ideal for shepherding the firm from an R&D enterprise into the commercial sector. Prigent takes over as CEO on 16 September.
Genfit is expecting Phase III data for its non-alcoholic steatohepatitis (NASH) candidate elafibranor before the end of 2019, which if positive keeps it in position to potentially be the second firm to market with a NASH therapy, behind Intercept Pharmaceuticals Inc.
Co-founder and current CEO Jean-Francois Mouney, who will remain as chairman of the board, stressed that the transition is being made at his request. No external candidate search was conducted.
In a video presentation posted to Genfit’s website, Mouney said that at Prigent’s urging he will remain present and active in supporting executive management’s efforts. The board also will add three new members over the next year to enhance the company’s expertise in activities related to US drug launches. While seeing Genfit through the expected filing of elafibranor for approval in the US and Europe in 2020, Prigent also is charged with managing the firm’s transformation from a French biotech into an international company with a strong foothold in the US, Mouney said.
Perhaps to reflect that transition, Prigent spoke in both French and English on the video, saying Genfit is going to stay on its present course with the teams it has in place. He emphasized that, along with Intercept, Genfit is one of two companies poised to bring a NASH drug therapy to market in the near-term and asserted that its investigational fibrosis diagnostic, NIS4, could have a game-changing impact in NASH. (Also see "Genfit Hopes To Make Case For First-Line Treatment In NASH" - Scrip, 4 Apr, 2019.)
Also participating in the video was co-founder and chief scientific officer Dean Hum, who recently took on the chief operating officer role as well. Hum, in charge of development and regulatory activities, will be second in command to Prigent, Mouney noted. Hum’s promotion came in tandem with Genfit’s $135.1m US initial public offering in March, which was intended partially to increase the company’s presence in the US. (Also see "Finance Watch: Genfit Launches IPO To Expand US Presence Ahead Of Phase III NASH Results" - Scrip, 28 Mar, 2019.) Genfit divides its 180 employees between Lille, France, and Boston.
At The Front Of The NASH Pack
Genfit expects to report data from its 72-week, Phase III RESOLVE-IT study of elafibranor in NASH before year’s end, hoping the dual PPAR agonist will demonstrate an ability to resolve NASH without worsening of fibrosis. Intercept’s obeticholic acid (OCA) – branded as Ocaliva for primary biliary cholangitis – demonstrated the ability reduce NASH patients’ fibrosis scores by one stage or greater in the Phase III REGENERATE study. (Also see "Intercept Retakes The Lead In NASH" - Scrip, 19 Feb, 2019.)
With its FXR agonist, Intercept became the first company to produce successful Phase III efficacy data in NASH and is on track to file a new drug application (NDA) at the US Food and Drug Administration for OCA in NASH fibrosis before the end of the third quarter. Intercept said during its second quarter earnings call on 7 August that it also is working toward applying to treat NASH cirrhosis with the 900-patient Phase III REVERSE study, expected to yield data in 2021.
Finding The Right Leadership
SVB Leerink analyst Pasha Sarraf called Mouney’s decision to “pass the baton” at Genfit to Prigent “a tremendous act of leadership to free the company to grow and execute with the experience it needs to manage the new obstacles it will face,” in a note issued on 3 September.
Sarraf also pointed to Prigent’s varied background in terms of geographic and therapeutic area expertise, with specialization in product launch, market access, business turnaround and growth strategies. As head of GSK’s US vaccines business and before that as a Lilly executive, Prigent held “various country and divisional roles, across marketing, sales and general management experience in Europe, the US and Latin America and in diverse therapeutic settings, including cardiovascular, diabetes, neuroscience and respiratory,” the analyst wrote.
The Leerink analyst also credited Mouney as being a visionary in recognizing and addressing the need for non-invasive diagnosis of NASH, where the current standard is liver biopsy. “Mouney quickly saw the value of a blood-based diagnostic in simplifying the approach in access for patients and directed Genfit’s resources to identify, build and test a practical algorithm for diagnosing patients with inflammatory disease, currently largely identifiable via biopsy,” Sarraf said.
Genfit inked a partnership around the experimental NIS4 diagnostic, which is incorporated into its Phase III program, with LabCorp in January.