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

Key Terms

lanham act regulatory

A federal law that sets the rules for protecting trademarks, preventing false advertising, and stopping unfair competition in the U.S.; think of it as the legal lock and guard that helps businesses keep exclusive use of their brand names, logos and product claims. Investors care because Lanham Act cases can affect a company’s brand value, sales and reputation, and they can trigger costly lawsuits or settlements that change future revenue and risk.

real-world evidence medical

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

substantial evidence regulatory

Substantial evidence is the level of reliable, well-documented proof regulators expect before accepting a company’s claim—most often that a drug or treatment works or that a key disclosure is supported. For investors it matters because it’s the threshold that can trigger approvals, label claims, or stop regulatory challenges; think of it as enough sturdy puzzle pieces or a balanced set of scales that make the overall picture persuasive to an expert reviewer.

phase iii medical

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

randomized controlled trials medical

Randomized controlled trials are studies where participants are randomly assigned to receive either a new treatment or a comparison (such as a standard treatment or placebo), so outcomes can be fairly compared like flipping a coin to decide teams. For investors, they matter because they provide the most reliable evidence about whether a drug, device or intervention actually works and is safe, which influences regulatory approval, market demand and the financial outlook of companies developing them.

retrospective data review technical

A retrospective data review is the process of examining existing records, test results, or case files from past activities to identify patterns, outcomes or safety signals without running a new experiment. For investors, it matters because these reviews can reveal real-world effectiveness, risks, or regulatory issues that affect a product’s market potential—think of it like checking past receipts and bank statements to predict whether a business habit is likely to continue or cause trouble.

comorbidities medical

Comorbidities are other medical conditions a patient has alongside a primary illness, like extra weight in a car that makes the trip harder. For investors, they matter because additional illnesses can change how well treatments work, raise healthcare costs, affect insurance payouts and regulatory trial results, and therefore influence the market size, pricing, and risk for drugs, devices, and health services.

majority of patients medical

Majority of patients means more than half of the people in a clinical trial, treatment group, or reported case series. For investors, it signals that an outcome—such as benefit, side effect, or response—was observed in over 50% of participants, which helps assess how likely a therapy or safety issue is to affect real-world use and market demand; think of it as more than half of a classroom experiencing the same result.

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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.

About Bayer
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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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223191970/en/

Contact for media inquiries:
Polina Miklush
polina.miklush@bayer.com

Source: Bayer