Bayer has filed a lawsuit against Johnson & Johnson (NYSE:JNJ) and its subsidiary Janssen Biotech, alleging the healthcare giant is using "scientifically flawed" and misleading marketing to steal market share for its prostate cancer treatment, Erleada.
The complaint, filed Monday in the U.S. District Court for the Southern District of New York, asserts that J&J violated the Lanham Act by promoting a retrospective real-world evidence (RWE) analysis that claims Erleada is superior to Bayer's rival drug, Nubeqa.
Bayer characterizes the analysis as intentionally deceptive and riddled with "fatal methodological flaws."
The legal battle centers on a concentrated market for androgen receptor inhibitors.
J&J recently published data claiming a 51% reduction in the risk of death for Erleada patients compared to those on Nubeqa.
Bayer argues this claim is "patently untrue," noting that 60% of the patients in the study had not been on the treatment long enough to support J&J's reported 24-month follow-up period.
Bayer’s complaint outlines several specific grievances.
Bayer alleges J&J compared Nubeqa use primarily in unapproved settings (without the chemotherapy drug docetaxel), creating an inherent skew in the results.
The company also argues that the Erleada patient group was five times the size of the Nubeqa group, which Bayer argues undermines the statistical validity of the comparison.
The lawsuit maintains that J&J’s claims do not meet the FDA’s "substantial evidence" standard, which typically requires controlled, prospective clinical trials rather than retrospective data reviews.
The lawsuit comes at a time of heightened competition in the oncology space.
Nubeqa has been a significant growth driver for Bayer, reaching blockbuster status with over $1 billion in annual sales.
J&J's Erleada is its primary competitor in the non-metastatic and metastatic castration-sensitive prostate cancer segments.
J&J has not yet filed a formal response to the lawsuit, but has previously defended its real-world evidence as a vital tool for informing clinical decisions in the absence of impractical head-to-head trials.