J&J, Bayer fail at their second big attempt to spotlight a safe benefit for clot-buster Xarelto in VTE

J&J and Bayer have run into a major setback in their long-running quest to widen the market for their clot-busting drug Xarelto. Their second crack at finding a safe benefit for at-risk patients facing incidents of venous thromboembolism (VTE) — clots in the deep veins — flopped in a major study of more than 12,000 patients who enrolled in the Mariner trial.

And this one proved a nasty surprise.

Patients in both the drug and control arms of the study experienced roughly the same outcomes, failing to offer a clear benefit for the therapy and axing the pharma partners’ hopes that they could add to their revenue.

Credit Suisse had said earlier that a success here could significantly boost the market for this big blockbuster of theirs — and gave the researchers very good odds of success after they had a chance to design the study to correct for earlier mistakes that may have spiked an earlier trial.

The difference in risk (rivaroxaban minus placebo) was −0.27 percentage points (95% CI, −0.61 to 0.08).  The p value hit at a failed 0.14. The data were published in the New England Journal of Medicine.

Their failure could prove a big plus for Portola, though, which has been struggling to sell the rival Bevyxxa, which is approved for VTE. Credit Suisse had said a failure for Mariner could help the biotech reach peak sales of $750 million. And investors paid close attention driving up Portola’s stock by 5% in early trading. It didn’t last, though. By mid-morning the stock was down 2%.

The two big pharma partners set their sights on this second stab at VTE after their big Magellan trial actually demonstrated efficacy back in 2011, but also hiked the risk of bleeding. Here they were looking to repeat the efficacy, while controlling the risk.

It didn’t work.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,500+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->