According to a Reuters report on August 26, 2018, Bayer and Johnson & Johnson announced that the market launch process for their cardiac drug Xarelto had encountered setbacks, as a study targeting a potential new subgroup of patients failed to demonstrate statistically significant benefits.
According to The New England Journal of Medicine, this blockbuster drug for thrombosis prevention failed to reduce the incidence of dangerous blood clots after discharge in certain high-risk patients in the MARINER clinical trial. Participants in the MARINER study had previously been hospitalized for a range of conditions associated with an elevated risk of venous thromboembolism, such as heart failure, acute respiratory diseases, ischemic stroke, or infection.
According to Bayer’s report last year, Xarelto generated €1.3 billion ($3.77 billion) in revenue for the company, primarily from stroke prevention in elderly patients. The drug also received approval in July for the treatment of patients with atherosclerosis, representing a potentially lucrative market. The company expects annual sales of Xarelto to exceed €5 billion.
A Bayer spokesperson stated that the latest results would also be presented at the European Society of Cardiology Congress in Munich. The company expects these findings will not alter its peak sales forecasts, nor have they affected the approval of Xarelto for other indications. Nevertheless, this remains a setback for Bayer.
Bayer holds the marketing rights for Xarelto outside the United States, while its partner Johnson & Johnson is authorized to sell Xarelto in the U.S., with Bayer receiving royalties amounting to 20%-30% of U.S. sales.