Bayer has filed a false advertising lawsuit taking issue with claims made by Johnson & Johnson to pit their prostate cancer drugs against one another.
Bayer sued its Xarelto partner in the New York district court on Monday, alleging in the complaint that J&J “launched a false advertising campaign” against Bayer’s Nubeqa this month, as Nubeqa has emerged as a significant rival to J&J’s own Erleada.
For evidence, Bayer pointed to a press release that J&J issued Feb. 2, in which it touted a “real-world head-to-head analysis” comparing overall survival rates after 24 months in patients treated either with Erleada or with darolutamide—the active ingredient in Nubeqa—both without the chemotherapy docetaxel.
Based on clinical data from U.S. medical and insurance databases, the retrospective analysis concluded that patients with metastatic castration-sensitive prostate cancer first treated with Erleada experienced a 51% reduction in risk of death compared to those who initially received Nubeqa. At the 24-month point, about 92% of the 1,460 Erleada patients included in the analysis were still living, compared to just under 86% of 287 Nubeqa patients.
J&J has since gone on to promote the findings in a slideshow presentation and one-page overview available on its Medical Connect website for healthcare providers, per the lawsuit.
According to Bayer, the analysis is “scientifically flawed” and “misinforms healthcare providers and patients in an effort to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market,” as the company wrote in a Monday release announcing the suit.
Bayer said it filed the lawsuit following “J&J’s refusal to cease and desist” its promotion of the head-to-head analysis.
In a statement sent to Fierce Pharma Marketing, a J&J spokesperson said, “Johnson & Johnson stands by the rigor and integrity of our real-world, head-to-head analysis that shows a 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA (apalutamide) versus darolutamide without docetaxel through 24 months. Litigation does not change data.”
The statement continued, “Our analysis was designed to meet rigorous guidance on real-world evidence, and this legal action demonstrates Bayer’s obvious misunderstanding of methodological frameworks and real-world evidence principles.”
Bayer laid out several of what it termed the “numerous and fatal methodological flaws” at the core of the analysis.
For one, it said, J&J’s use of retrospective real-world data in the head-to-head comparison does not align with the FDA’s more rigorous standards for claiming direct superiority. For another, it suggested that the considerable difference in cohort sizes “skews statistical analyses and undermines the reported outcomes.”
Bayer also pointed out that Nubeqa hadn’t been approved for use without docetaxel for “97% of the time period used in the J&J analysis.” That approval arrived last summer; the analysis stretched from August 2022 to June 2025.
That factor “creates severe selection bias and makes the superiority claim inherently false,” according to Bayer, which claimed that the analysis further compounded concerns linked to off-label use of Nubeqa by failing to “adequately measure and balance critical prognostic and baseline characteristics, such as non-cancer comorbidities.”
Elsewhere, Bayer took issue with J&J’s claim that the analysis followed patients through 24 months: “This is patently untrue as at least 60% of patients in both cohorts initiated their treatment after June 2023 and could not have been evaluated for 24 months of follow-up before the analysis ended in June 2025,” it wrote in this week’s release.
In the lawsuit, Bayer requested a permanent injunction stopping J&J from disseminating the analysis and its claims, as well as an order for its rival to put out a “corrective press release” dispelling the claims.
Bayer is also asking for a judgment that would require J&J to pay Bayer its “unjust profits,” as well as both compensatory and threefold punitive damages and reimbursement for Bayer’s court costs. The complaint alleges damages of at least $75,000, a typical federal court jurisdictional threshold, though the final amount has not yet been determined.
Editor's note: This story was updated at 3:30 p.m. ET with a statement from Johnson & Johnson.