Roche ends U.S. sales of Esbriet, closing a decade-long chapter

USA – A decade after acquiring InterMune for US $8.3 billion, Roche has sold the U.S. rights to Esbriet (pirfenidone) and InterMune to Legacy Pharma Inc. SEZC.

Legacy Pharma said the acquisition “underscores [the company’s] commitment to expanding its portfolio of high-quality pharmaceutical products and enhancing patient access to innovative treatments.”

Esbriet, approved by the FDA in 2014 for treating idiopathic pulmonary fibrosis (IPF), achieved peak sales of approximately US $1 billion in 2021.

However, following patent expiration in 2022 and subsequent generic competition, sales declined to around US $100 million by 2024.

Roche retains rights to Esbriet outside the U.S. and continues to invest in IPF research, notably through an anti-OSMRβ antibody licensed from Kiniksa Pharmaceuticals in 2022, currently in mid-stage clinical trials.

The IPF treatment landscape is becoming increasingly competitive, with several companies advancing novel therapies:

• Boehringer Ingelheim is preparing to file for regulatory approval of nerandomilast, an oral PDE 4B inhibitor, following positive results from two Phase 3 trials.
• Galecto Biotech is developing GB0139, an inhaled inhibitor of galectin-3, targeting fibrotic lung diseases like IPF. GB0139 has shown promise in reducing fibrosis in preclinical models.
• United Therapeutics is conducting the TETON 1 and TETON 2 studies for treprostinil in IPF patients, aiming to expand its portfolio in rare lung diseases.
• Pliant Therapeutics is advancing PLN-74809, an oral small-molecule dual-selective inhibitor of αvβ6 and αvβ1 integrins, currently in Phase 2a trials for IPF. The drug has received Fast Track and Orphan Drug Designations from the FDA.
• Refoxy Pharma has secured €9.1 million (US $9.58 million) in a financing round led by Boehringer Ingelheim Venture Fund to develop a preclinical IPF drug candidate targeting the FOXO3 protein, aiming to modulate fibrotic processes.
• Avalyn Pharma is developing inhaled therapies for rare respiratory diseases, including pulmonary fibrosis, aiming to deliver effective treatments directly to lung tissue.