Xarelto researchers wow analysts with blockbuster PhIII data

Investigators for Bayer and J&J ($JNJ) have pulled back another veil from the body of late-stage data on the blood thinner Xarelto. Indeed, they have wowed analysts with evidence that the would-be mega-blockbuster demonstrated considerably improved efficacy over warfarin in preventing strokes with an improved safety profile for preventing intracranial bleeding.

The 14,264 patients enrolled in the massive late-stage study delivered a 21 percent improvement in stroke reduction over warfarin, an old and highly problematic drug that has long been a big, fat target for some of the world's biggest developers. Risk of fatal bleeding was halved in the Xarelto arm of the study, according to researchers at the American Heart Association meeting.

With a once-daily dosing regimen for Xarelto, some analysts say the experimental therapy is shaping up as an even bigger sales winner than they had earlier expected. Reuters notes that some analysts already expect the therapy to earn $5 billion. But other analysts zeroed in on a second analysis of the data, according to Bloomberg, which highlighted the equivalent profile of Xarelto and warfarin--a result that would give Boehringer Ingelheim's recently approved Pradaxa an edge in the market.

"The big advantage Pradaxa has is the data looks very good, everyone has been poring over it for ages, and it's now on the market without a competitor," Bernstein's Alex Blanckley tells the business news service. "If Xarelto's data is the same, it would only be second to market." Bernstein has estimated potential Xarelto income at $3.9 billion a year.

- see the Reuters story
- read the report from Bloomberg