Pirfenidone

Roche’s $8 billion InterMune acquisition, disclosed a decade ago, is now being handed to a specialty pharmaceutical company. Cayman Islands-based Legacy Pharma is run by Mark Thompson , the former CEO of Concordia, another specialty pharma that had a price-hiking reputation . It put out a short press release last week saying it had completed the acquisition of InterMune and the US IP rights to its idiopathic pulmonary fibrosis medicine Esbriet (pirfenidone) from Roche’s Genentech for undisclosed terms. Legacy said it would “ensure the continued availability and distribution of Esbriet to patients​ ​across the United States.​” Genentech will provide access to the drug “until the completion of the business transfer” and Roche keeps ex-US commercial rights, according to the press release. Esbriet was the “only medicine in the Roche pipeline” that derived from InterMune, and it is available in about 40 countries, a Roche spokesperson told Endpoints News via email. The divestiture of Esbriet wasn’t entirely surprising. Roche confirmed to Endpoints last February that it was looking at offloading Esbriet. “We have strict confidentially [sic] provisions with Roche and cannot say more than what is in the press release. The transaction was funded internally,” Thompson wrote in an email to Endpoints. Sales of Esbriet, which has had generic competition since 2022, sank 56% from 2023 to 2024, Roche said last week. It reeled in $54 million in 2024, according to Roche’s annual report. Boehringer Ingelheim markets the only other approved drug for IPF, which destroys lung capacity and can lead to death for many patients within five years. Multiple biotechs are attempting to create new medicines. Not much is known about Legacy. It’s led by Thompson and chief financial officer Adeel Ahmad, the former CFO of Concordia, which rebranded to Advanz Pharma in 2018. Its president and general manager, Chris Humphrey, also comes from Advanz, according to his LinkedIn profile. Thompson posted on LinkedIn about the InterMune deal late last week, calling it a “Big Day!” A few months ago, Thompson posted to the networking site to say Legacy had acquired a “basket of products” from Sebela Pharmaceuticals, including the antifungal Naftin, to bring the company’s portfolio to 22 prescription products. A year ago, it acquired Allegis Pharmaceuticals and Marnel Pharmaceuticals, Thompson also wrote on LinkedIn. Northern Private Capital helped fund the deal, he added. At the time, it had 40 employees across multiple cities, including Scottsdale, AZ and Bridgetown, Barbados, according to the CEO. In his weekly biopharma market report on Monday, Stifel healthcare managing director Tim Opler said there were a “few things of interest” regarding the deal. “First, Roche has obviously thrown in the towel on its Intermune deal– after paying $8.1 billion for it,” Opler wrote. “Second, the buyer’s CEO, Mark Thompson, has an impressive track record. He previously built Concordia Pharma up from zero to over $3bn in value by purchasing pharmaceutical ‘tail assets.’ Let’s watch what he does this time. If we were the betting type, we would put money on Legacy Pharma to do well.”

A committee of clinical trial monitors has advised Pliant Therapeutics to stop giving its experimental fibrosis drug to patients in a Phase 2 trial, seeding doubt about the therapys future.Pliant said in a short statement late Friday that, following a routine data check by the committee, the company has voluntarily stopped enrolling and dosing patients with its drug, bexotegrast, in a Phase 2b/3 trial in idiopathic pulmonary fibrosis.Pliant didnt say whether the trial was stopped due to safety concerns or its drug being ineffective two reasons an independent data committee might call for a pause in dosing. The company is currently reviewing data to understand the [committees] rationale, it said, and will keep the study blinded to preserve trial integrity.Current study volunteers will remain in the trial and be monitored while the review is underway. In the meantime, though, the company has informed investigators of the data boards decision and is in the process of disclosing the news to global health regulators.The announcement, and lack of specific details involved, took investors and Wall Street analysts by surprise. This is a unique situation that we (and most investors we have spoken to) have never seen before, wrote Leerink Partners analyst Faisal Khurshid, in a research note on Sunday.Without those details, Khurshid, and other analysts following the company, were left to speculate what might have triggered the trial monitors decision. An independent data safety monitoring board periodically evaluates safety and efficacy data throughout a clinical trial. The committee also follows certain guidelines, one of which is to recommend a company immediately unblind and stop a trial because an experimental treatment is clearly unsafe or ineffective.Notably, in Pliants case, Khurshid wrote, the dosing halt is voluntary and the study is still blinded. That could mean data reviewers saw something that gave enough concern to stop treating patients, but not enough to end the study altogether, he wrote.Our understanding is [Pliant] management does not know the exact findings, he added, which seems like an impasse because Pliant would have to choose between unblindingthe study and losing its progress, or trying to resolve the issue while keeping the trial intact.At best, this may be resolvable by determining the trigger and perhaps modifying dosing/population in conjunction with [Food and Drug Administration], albeit with some added risk and disruption, wrote Brian Abrahams, of RBC Capital Markets. But at worst, it may reflect an insurmountable imbalance in toxicity or mortality, spelling the end of the program.Abrahams speculated the latter, given safety concerns have been observed in testing of drugs with similar mechanisms as bexotegrast.Company shares fell by more than 60% in pre-market trading on Monday. At about $3 apiece, theyre at their lowest levels since Pliant went public at $16 per share in 2020.The setback leaves the status uncertain of a program that has been closely watched by analysts because of its potential in idiopathic pulmonary fibrosis, a rare lung condition thats long bedeviled drugmakers.Though two treatments are available in Roches Esbriet and Boehringer Ingelheims Ofev, neither are cures and several other prospects have failed in testing. Thats left room for companies like Pliant, whose drug impedes a protein involved in the formation of scar tissue, to come up with a better option.Earlier study results had indicated bexotegrast appeared safe and might help improve lung function. The ongoing study, BEACON-IPF, is a larger and longer late-stage trial designed to recruit about 360 participants and test whether bexotegrast can slow or halt disease progression after a year of treatment.Pliant had been expecting to complete enrollment this quarter and report results next year. '