NEW BRUNSWICK (dpa-AFX) - German pharmaceutical and life sciences major Bayer AG (BAYRY.PK, BAYZF.PK) announced that it has filed false advertising suit against Johnson & Johnson or J&J (JNJ) and Janssen Biotech, Inc. over the U.S. drug major's claims regarding NUBEQA for prostate cancer treatment.
Bayer alleges that J&J's claims regarding NUBEQA are deeply flawed and intentionally aimed at boosting sales of J&J's ERLEADA.
With the lawsuit filed in the United States District Court for the Southern District of New York, Bayer seeks preliminary and permanent injunctions in addition to damages.
The suit follows J&J's refusal to cease and desist its promotion of a scientifically flawed real-world evidence analysis, which conveys false information to patients and healthcare providers regarding the efficacy of NUBEQA.
The German firm noted that 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, a federal law.
The law prohibits a company from making false or misleading commercial representations about a product's safety, efficacy, or characteristics.
According to Bayer, superiority claims of ERLEADA are false and derived from an analysis with numerous and fatal methodological flaws. They are based on scientifically flawed data and are not supported by a true head-to-head clinical trial. With the flawed analysis, J&J aims to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market, the company noted.
Bayer added that J&J's real-world data analysis has other issues, such as almost exclusively unapproved use of NUBEQA; short follow-up time of less than 24 months for the majority of patients; treatment arms varied greatly in size; inferior data sources as the basis for its review; and improper control for comorbidities.
In the overnight trading, J&J shares were losing around 0.74 percent, after closing Monday's regular trading 1.4 percent higher at $245.84.
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