Bayer Alleges J&J’s Claims Regarding NUBEQA® are Deeply Flawed and Intentionally Aimed at Boosting Sales of J&J’s ERLEADA

Bayer files false advertising suit against J&J and Janssen Biotech

• Lawsuit seeks preliminary and permanent injunctions in addition to damages.
• This flawed J&J data analysis conveys false information to patients and healthcare providers; Superiority claims of ERLEADA® are based on scientifically flawed data and are not supported by a true head-to-head clinical trial.
• Other problems with the J&J real-world data analysis include: almost exclusively unapproved use of NUBEQA®; short follow-up time of less than 24 months for the majority of patients; treatment arms varied greatly in size; inferior data sources as the basis for its review; and improper control for comorbidities.

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that it has filed suit against Johnson & Johnson (J&J) and Janssen Biotech, Inc. in the United States District Court for the Southern District of New York. The suit follows J&J’s refusal to cease and desist its promotion of a scientifically flawed real-world evidence analysis that misinforms healthcare providers and patients in an effort to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market.

The lawsuit asserts that J&J makes false claims regarding the efficacy of NUBEQA®. J&J’s promotional efforts, which include a press release issued to media and two presentations made available on its Medical Connect website, are commercial speech aimed at promoting its branded product that violate the Lanham Act given their false and misleading nature. The Lanham Act is a federal law that prohibits a company from making false or misleading commercial representations about a product’s safety, efficacy, or characteristics.

As laid out in Bayer’s complaint, J&J’s claims of superiority of ERLEADA® are false and derived from an analysis with numerous and fatal methodological flaws:

• J&J’s data analysis does not adhere to the rigorous ‘substantial evidence’ standards set by the FDA for claiming definitive efficacy superiority, which requires well-controlled, head-to-head clinical trials. Rather, J&J’s superiority claims are improperly based on a flawed retrospective data review of real-world events that is riddled with problems.

• NUBEQA® was not approved for use without docetaxel during 97% of the time period used in the J&J analysis – a design feature that creates severe selection bias and makes the superiority claim inherently false.

• Compounding the concern of unapproved use of NUBEQA®, J&J did not adequately measure and balance critical prognostic and baseline characteristics, such as non-cancer comorbidities.

• The patient population on ERLEADA® in the analysis was five times the size of those taking NUBEQA®. Such a significant difference in cohort size skews statistical analyses and undermines the reported outcomes.

• J&J claims that its review compared patients through 24 months of follow-up. 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.

NUBEQA® is supported by a comprehensive body of Phase III randomized evidence in both metastatic castration‑sensitive and nonmetastatic castration‑resistant prostate cancer, reinforcing safety and efficacy of NUBEQA®. Randomized controlled trials remain the gold standard for establishing treatment safety and efficacy. For more information on the safety and efficacy of NUBEQA®, please visit here.

Bayer is committed to high quality science that is designed to test ideas, challenge assumptions, and build knowledge over time.

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Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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