In a blow to Bayer, a U.S. federal judge in Manhattan has said he will not block Johnson & Johnson’s survival claims on a key prostate cancer drug.
Back in February, Bayer filed a lawsuit taking issue with claims made by Johnson & Johnson in a fierce market clash between the companies' blockbuster prostate cancer meds.
Bayer alleged that J&J “launched a false advertising campaign” against Bayer’s prostate cancer drug Nubeqa, as the drug has become a significant rival to J&J’s own Erleada.
The German pharma pointed to a press release that J&J issued Feb. 2, in which it touted a “real-world head-to-head analysis” comparing overall survival rates after 24 months in patients treated with either with Erleada or with darolutamide—the active ingredient in Nubeqa—both without the chemotherapy docetaxel.
Based on clinical data from U.S. medical and insurance databases, the retrospective analysis concluded that patients with metastatic castration-sensitive prostate cancer first treated with Erleada experienced a 51% reduction in risk of death compared to those who initially received Nubeqa.
At the 24-month point, about 92% of the 1,460 Erleada patients included in the analysis were still living, compared to just under 86% of 287 Nubeqa patients.
J&J later shared the findings in a slideshow presentation and in a one-page overview on its Medical Connect website for healthcare providers, according to the lawsuit.
According to Bayer, the analysis was “scientifically flawed” and “misinforms healthcare providers and patients in an effort to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market,” the company said in a Feb. 23 release when it first issued its complaint.
Weighing up the evidence, U.S. District Judge Dale Ho ruled on Friday that Bayer did not show it was likely to succeed on the merits of its claims, and that J&J’s communications were accurate. He turned down Bayer’s request for a preliminary injunction.
“Based on the current record,” the judge wrote in his decision and reported by Reuters, "the methodological choices made by the authors of the study were not errant or out-of-step within the relevant scientific community.”
J&J told Fierce Pharma Marketing in a statement: “This ruling is a win for scientific exchange and a strong win for patients. The Court wholly rejected Bayer’s effort to restrict the communication of important data that can help inform treatment decisions and validated the robust methodology of Johnson & Johnson’s scientific rigor and real-world analysis of Erleada and its impact on patient outcomes.”
In its case, Bayer requested an injunction stopping J&J from disseminating the analysis and its claims, as well as an order for its rival to put out a “corrective press release” dispelling the claims. The German pharma also asked for a judgment that would require J&J to pay Bayer its “unjust profits,” as well as both compensatory and punitive damages and reimbursement for Bayer’s court costs.
Bayer told Fierce in a statement: “This decision comes at a very early stage in the case and only addresses the preliminary, pre-trial relief sought by the company. Significantly, the court found that Bayer presented a ‘plausible hypothesis’ of methodological problems with the J&J study but lacked ‘empirical data’ to support it. During the merits phase, Bayer will seek this data once again through the discovery process and is confident that the Company will be able to provide sufficient data to the court to demonstrate the flaws in the study’s methodology and its false conclusions.
“Bayer maintains that J&J’s superiority claims over Nubeqa are false, misapply real-world evidence, mislead prescribers and patients, and are intended to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market.”