Big trial failure for Xarelto in clot prevention won’t affect sales, Bayer vows

Xarelto didn't outperform aspirin in the secondary prevention of stroke and embolism, Bayer said, but that shouldn't affect peak sales.

Last year, Bayer was so confident about its best-selling drug, the $3.4 billion-a-year blood thinner Xarelto, that it told analysts to expect the product’s sales to peak at more than $5.3 billion a year. So when the German pharma giant said late yesterday that it stopped a trial of Xarelto in the secondary prevention of stroke and embolism for lack of efficacy, analysts would have been forgiven for taking an ax to their estimates for the drug, which Bayer markets in partnership with Johnson & Johnson.

Not so fast, Bayer says. Just after announcing the demise of the trial, the company promised the disappointment would not affect its sales estimates for Xarelto.

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In the study, patients taking Xarelto were compared with those taking low-dose aspirin. The patients had all recently suffered strokes, and the study demonstrated that the drug did no better than aspirin at preventing future strokes.

But that was only part of the problem. Bayer said in a statement that bleeding rates were higher in the Xarelto arm than they were among patients taking aspirin.

The bleeding risk with Xarelto is already well known. In fact, Bayer and J&J are facing more than 18,000 lawsuits over the side effect in state and federal courts. So far, the companies have had the upper hand in the litigation: In August, a jury in a Mississippi federal court ruled in favor of the drugmakers in a case brought by a woman who alleged Xarelto caused an abdominal bleed after surgery. It was the third win for the companies.

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Still, a positive result in the stroke-prevention trial would no doubt have made it easier for Bayer and J&J to reach their lofty sales goal for Xarelto. The main source of revenues now for the drug is for the prevention of stroke in patients with atrial fibrillation. And the product has formidable rivals in Eliquis from Pfizer and Bristol-Myers Squibb and Boehringer Ingelheim’s Pradaxa, with BI boasting the advantage of having an approved product that can be used alongside it in cases of uncontrolled bleeding.

Portola is working on a similar bleeding-reversal agent that will work with Xarelto called AndexXa, but the effort was slowed last year when the company got a complete response letter from the FDA citing manufacturing problems and other issues. Portola had to draw $50 million in loans from partners BMS and Pfizer to address the FDA’s concerns. In August, Portola announced the FDA accepted its resubmitted application for approval and will make a decision by February 2.

One of the reasons Bayer may be so confident about hitting that $5.3 billion peak sales goal for Xarelto is that it did chart one piece of good research news recently. At the European Society of Cardiology meeting in August, Bayer and J&J released data showing that Xarelto paired with aspirin slashed the risk of adverse cardiovascular events in patients with coronary artery disease and/or peripheral artery disease by 24% over aspirin by itself. One analyst predicted that would be enough to drive a $1.5 billion annual increase in Xarelto sales in the U.S. alone.