By Jonathan Stempel
NEW YORK, Feb 23 (Reuters) – Bayer sued Johnson & Johnson on Monday, accusing the drugmaker of falsely advertising a rival multibillion-dollar drug to treat prostate cancer.
In a complaint filed in Manhattan federal court, Bayer said Johnson & Johnson is causing irreparable harm through a campaign begun this month for the drug Erleada that threatens to erode trust in the German company’s drug Nubeqa.
Bayer said Johnson & Johnson falsely claimed that patients treated with Erleada had a “51% reduction in risk of death” compared with Nubeqa patients, in testing that replicated a clinical trial and adhered to “rigorous” U.S. Food and Drug Administration standards.
According to the complaint, the two groups of patients were not comparable because most Nubeqa patients in the comparison received their drug off-label, creating “selection bias” that makes claims of superiority unreliable, and Johnson & Johnson’s study included five times more patients.
Bayer also said the FDA does not sanction the retrospective, real-world analysis that Johnson & Johnson allegedly used as a substitute for traditional clinical trials.
“By invoking FDA authority to lend unwarranted credibility to scientifically flawed analyses, J&J has misled patients and healthcare providers,” the complaint said.
Johnson & Johnson, based in New Brunswick, New Jersey, did not immediately respond to requests for comment.
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By Jonathan Stempel NEW YORK, Feb 23 (Reuters) – Bayer sued Johnson & Johnson on Monday, accusing the drugmaker of falsely advertising a rival multibillion-dollar drug to treat prostate cancer...