Nerandomilast

Boehringer Ingelheim is projecting a "slight" revenue increase in 2025 but admitted its estimates are clouded by uncertainty over the U.S. regulatory environment and potential U.S. tariffs for pharmaceutical products. Boehringer Ingelheim picked a challenging day to reveal its 2024 financial results and guidance for this year.With President Donald Trump announcing his plan on tariffs on Wednesday and uncertainty surrounding if and how they will affect the export of pharmaceutical products to the U.S., the German company is treading lightly with its projection of a “slight year-on-year increase” in revenue.“We don't even know whether there are going to be tariffs,” Chairman Hubertus von Baumbach said on Wednesday morning during the company’s annual press conference.There are other uncertainties in the U.S. for Boehringer, which is the largest privately-owned company in the industry and has overtaken Bayer as Germany’s top seller of pharmaceuticals.For one, the drugmaker has two key products under review by the FDA, both of which Boehringer hopes to launch in the second half of this year. But with the U.S. regulator in a state of flux, von Baumbach said he isn’t sure “to what extent it will impact our ability to register products.”“All we have is the information that people are being laid off,” he added. “Like in the case of tariffs, let’s wait and see.” As for 2024, Boehringer’s revenue reached 26.8 billion euros ($29 billion), which was a 4.7% increase and a 6.1% bump at constant exchange rates.Jardiance continued as Boehringer’s top product, generating revenue of 8.4 billion euros ($9.1 billion), which was up by 15%. Sales of the aging diabetes medicine have been boosted in recent years by its approval to treat heart failure. However, that momentum is slowing after Boehringer reported increases for Jardiance of 39% in 2022 and 30% in 2023.Boehringer’s second-leading product, Ofev saw a 9% bump in sales to 3.8 billion euros ($4.1 billion). With the company losing patent protection for the idiopathic pulmonary fibrosis treatment by the end of this decade, it is banking on follow-on nerandomilast, which is under review in the U.S. and Europe. Boehringer also hopes to launch zongertinib this year. It would be the first orally administered, targeted therapy for previously treated HER2-mutated lung cancer patients.“As our current pipeline continues to mature and more products come closer to a potential market introduction, we have entered a pivotal phase of high investments,” von Baumbach said in a release, referring to Boehringer’s pharma R&D investment figure of 5.7 billion euros ($6.2 billion), which was 28% of the division’s sales.

iStock, cienpies The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial. Pliant Therapeutics will assemble an external panel of experts to review data from the ongoing Phase IIb BEACON-IPF trial of its investigational integrin inhibitor bexotegrast in idiopathic pulmonary fibrosis, the biotech announced on Thursday. The move comes after an independent data safety monitoring board (DSMB) last week recommended that the study be put on hold—something that Pliant “has not been able, through review of blinded data, to determine the rationale for,” according to Thursday’s press announcement. The biotech expects the outside review to finish in two to four weeks. To review the DSMB’s recommendations, Pliant will bring together what it described as “world-renowned experts in pulmonary diseases and biostatistics” to examine BEACON-IPF’s unblinded data and give the company their independent assessment of the findings. Following the outside review, the panelists will act as an “expanded” DSMB and work with the existing monitors to “reach a consensus recommendation” regarding the path forward for BEACON-IPF, according to Pliant’s announcement. Pliant’s shares rose 28% on Thursday following its announcement, according to Seeking Alpha , giving the biotech some breathing room after its 58% stock crash following the trial pause announcement last week. Bexotegrast is a small-molecule drug candidate that works by targeting and blocking the α v β 6 and α v β 1 integrins, which are typically overexpressed in fibrotic tissue. Bexotegrast thus prevents the formation and growth of scar tissue—a hallmark of idiopathic pulmonary fibrosis. Phase IIa data released in May 2024 reveal a strong reduction in lung collagen levels after bexotegrast treatment, whereas placebo counterparts saw an increase in the protein. Excessive collagen deposits in the lungs are a hallmark of idiopathic pulmonary fibrosis. Bexotegrast also boosted lung function and lowered cough severity versus placebo. At the time, Pliant said that these findings point to the “potential reversal of fibrosis” with bexotegrast. Lung fibrosis is a popular target for biopharma and is shaping up to be a competitive field, with several clinical successes and high-ticket deals in the past year. Just last week, for instance, Boehringer Ingelheim revealed a Phase III win for nerandomilast, which significantly improved lung function versus placebo in patients with progressive pulmonary fibrosis. Six months earlier, Boehringer reported similar lung function improvements with nerandomilast in idiopathic pulmonary fibrosis. And last month, Eli Lilly signed a potential $780 million global partnership with Mediar Therapeutics to advance a first-in-class therapy for idiopathic pulmonary fibrosis.