GENFIT

new market research data highlight potential of elafibranor in PBC - Seite 2

Pr. Sven Francque, Chairman of the Department of Gastroenterology and Hepatology of the University Hospital Antwerp, commented: “PBC is a serious liver disease, and unfortunately, we still see patients who inevitably progress to later stages, developing decompensated cirrhosis and requiring a liver transplant, confirming the significant need for novel PBC therapies. Clinical studies have demonstrated that PPAR alpha and PPAR delta agonists have positive effects on PBC patients. Elafibranor activates both PPAR alpha and delta simultaneously, therefore we can hypothesize a synergistic effect to potentially enhance the positive outcome in PBC patients.”

Dr. Kris V. Kowdley, Director, Liver Institute Northwest, Clinical Professor Elson S. Floyd College of Medicine, Washington State University added: “PBC can be a debilitating disease with a profound impact on a patient’s quality of life. As one of my patients explained during the call, the most difficult symptom remains pruritus, a severe itching causing extreme discomfort which is experienced as a real burden. Finding a treatment that could halt the progression of the disease and concurrently improve symptoms would address many of the existing challenges faced by patients with PBC.”

PBC Commercial Opportunity

PBC represents a significant market opportunity for GENFIT as the disease has a clear regulatory pathway and is well understood by payors and KOLs. IQVIA, a recognized leader in research and consulting services for the pharmaceutical industry, was commissioned by GENFIT to conduct three comprehensive market research studies evaluating the potential market opportunity, should it be granted regulatory approval, of elafibranor as a second line treatment.

The total PBC market is estimated to reach $1.5 billion annually in 2035, and elafibranor, if approved, could achieve $515 million in peak year revenue, as second line treatment for patients with PBC that cannot benefit from the first line therapy.

Julien Perrier, VP Global Account at IQVIA, commented: “It is estimated that 90,000 patients could be treated with elafibranor by 2030, if approved. Our payer and KOL research, based on a robust methodology involving 28 KOLs, 240 healthcare professionals and 15 US and EU payors, showed that elafibranor is considered to have the potential for a strongly differentiated profile in terms of safety, efficacy, and improvement on pruritus. Our research model, based on conservative assumptions, shows that elafibranor’s profile could potentially justify a market penetration of ~32% in the United States and ~22% in the EU in 2035.”