Judge Says Bayer’s Claim Against J&J Is Unfounded

A Manhattan federal judge has ruled against Bayer’s bid to stop Johnson & Johnson from advertising its prostate‑cancer drug Erleada. The decision, based on a 41‑page opinion by Judge Dale Ho, found that Bayer had not demonstrated a likely victory over J&J’s marketing claims.
J&J promotes Erleada as cutting death risk by roughly half compared to Bayer’s own drug, Nubeqa.

Background

• Bayer's lawsuit (Feb 23): Accused J&J of misrepresenting clinical data and harming Nubeqa’s reputation.
• Key arguments:
• J&J’s studies relied on patients who received Nubeqa off‑label.
• The FDA had not approved J&J’s real‑world analysis as a substitute for traditional trials.

Judge’s Findings

• J&J’s statements are consistent with its own research findings.
• Bayer failed to identify major methodological flaws that would render J&J’s claims materially false.
• The study methods were deemed “not errant or out‑of‑step within the relevant scientific community.”

Reactions

• Bayer: Declared it will continue to pursue the case, asserting its evidence supports claims of false advertising.
• J&J: Welcomed the ruling as a victory for scientific dialogue and patient care, emphasizing the value of real‑world evidence when direct trial data are limited.

Industry Context

• Prostate cancer remains a major health concern, with over 300,000 new cases and nearly 36,000 deaths reported in the U.S. last year.
• Sales figures:
• Nubeqa – €2.39 billion
• Erleada – $3.57 billion