Johnson & Johnson’s and Bayer’s recent attempt to expand the market for its controversial anticoagulant, Xarelto, encountered a setback when the medication failed to prevent clotting in high-risk patients during a recent clinical trial.

Known as the MARINER Study, the trial involved approximately 12,000 patients who had been admitted to hospitals for a range of conditions that made them more vulnerable to venous thromboembolism, including infections, heart failure, stroke, and respiratory disease.

Participants were given Xarelto following their release from the hospital in hopes that the medication would reduce their risk of blood clotting.  According to the report published in the New England Journal of Medicine, there was no significant reduction in the rate of blood clotting among the patients who participated in the study. The results of the study were presented at this year’s congress of the European Society of Cardiology.

Despite the setback, Bayer remains optimistic about projected sales for Xarelto.  Last year, Xarelto accounted for just under $3.8 billion in revenues.  Analysts expect continued growth for Bayer’s flagship product, predicting as much as $5.75 billion in sales for the coming year.

The results of the MARINER trial will have no effect on other indications for which Xarelto has been approved.  This past July, the manufacturer gained approval from the FDA and the European Medicines Agency for patients suffering from atherosclerosis (more commonly known as hardening of the arteries).  Xarelto is marketed in the U.S. by Johnson & Johnson, while Bayer handles sales of the drug in all other countries. In addition, Bayer collects royalties on U.S. sales of up to 30 percent.

Johnson & Johnson is also optimistic about future Xarelto sales.  While acknowledging that the MARINER study did not provide the hoped-for results, a company spokesperson says Xarelto does “significantly reduce” the risk of embolism with “consistent and favorable safety.”

There are also approximately 21,400 plaintiffs with cases against the manufacturers who would question that data.  Injured parties allege that Bayer and Johnson & Johnson failed to warn doctors and their patients of the risks of uncontrollable hemorrhaging in emergency situations.

All of these injuries occurred prior to May of 2018 when the FDA finally approved an antidote developed by a small San Francisco-area biotech firm.  It is worth noting that “real-world” data “demonstrating” Xarelto’s safety and efficacy were based on studies funded by the manufacturer and has yet to be confirmed by independent, outside research.

Meanwhile, Bristol-Meyer Squibb (BMS), maker of the competing anti-coagulant drug Eliquis, is forging ahead with its own plans to expand the market for its own product.  Currently, BMS is preparing to explore the use of Eliquis for the prevention of blood clotting in cancer patients.  Undeterred by lawsuits and questions about Xarelto safety, Bayer is also conducting a study involving a similar patient population. That study, known as CASSINI, is scheduled for completion by the end of 2018.

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.