Bayer's Xarelto could gain edge from new ACS trial

Bayer CEO Marijn Dekkers has been resolute in his multibillion-dollar predictions for the company's new bloodthinner Xarelto, developed in partnership with Johnson & Johnson ($JNJ), despite every disappointment. And there have been several: Data suggesting better efficacy for in-development competitor Eliquis; news that Xarelto probably won't get a superior-to-warfarin claim on its FDA label; and first-to-market advantage for fellow German drugmaker Boehringer Ingelheim and its warfarin alternative Pradaxa.

But Dekkers now has some vindication. Xarelto cut the rate of heart attacks, strokes and cardiovascular death in patients with acute coronary syndrome versus a placebo in a new study. That's something Eliquis failed to pull off, Bloomberg notes; a trial of the Pfizer/BMS drug was halted in November 2010 because of severe bleeding risks.

And it's something that could give Xarelto a lift vis-à-vis its rivals. Bayer now plans to ask regulators in the U.S. and Europe to approve Xarelto to treat patients with ACS. It's already approved for clot prevention in some surgery patients, and the company is waiting for the FDA and EMA to decide about its stroke-prevention applications.

The ACS indication wouldn't be as big for Xarelto as stroke prevention promises to be, LBBW analyst Karl-Heinz Scheunemann told Dow Jones. Still, people weren't counting on ACS to figure in for Xarelto at all. "As expectations for Xarelto in acute coronary syndrome were zero, this is a positive for Bayer," Bernstein Research said in a note. "It at least opens the door to a potentially large and lucrative indication."

However, the ACS results came with an increased risk of bleeding. And it was bleeding that prompted Pfizer and BMS to stop that trial, data presented in this past July showed. The difference is that with Eliquis, "[i]t is very clear there is an increased risk of bleeding, and in most patients it doesn't appear there is a lot of benefit to outweigh the risk," one of the trial researchers told HealthDay at the time.

- read the Dow Jones story
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- see the piece in Forbes