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

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:

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.

Find more information at www.bayer.com.

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.