Pfizer/BMS data poses threat to BI's Pradaxa

When several drugmakers are developing similar new drugs, there's always a lot of talk about which one will reach the market first. In the case of clot-busting drugs to compete with the old standby warfarin, Boehringer Ingelheim won that race with Pradaxa. Since then, it's been a race for second-to-market status between Pfizer and Bristol-Myers Squibb's candidate apixaban--branded as Eliquis--and Bayer's Xarelto, approved in Europe but waiting for the FDA nod.

But now, new data on the Pfizer/BMS drug is throwing the contest into disarray. Pradaxa's first-to-market score may just be a token prize. That's because Eliquis, the yet-to-be-approved drug, aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than warfarin was--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug.

As Forbes notes, Eliquis had been considered the third-ranking drug in the warfarin-replacement crowd. Now, it might just find itself in first place. Boehringer's Pradaxa did perform better than warfarin, but the study wasn't totally blind, so the FDA didn't allow the company to claim superiority for its product. If the FDA allows Pfizer and BMS to slap a superiority note on Eliquis, their drug could gain a major edge. "At first blush, it's a home run for apixaban. It looks better than the other two drugs," as Barclays Capital analyst Tony Butler told Reuters.

Meanwhile, the data on Bayer's Xarelto shows the drug is equivalent to--not better than--warfarin on safety and efficacy, Forbes notes. But it's a once-a-day drug. So, it might have a dosing advantage; but then again, the lack of superiority could again give the edge to Eliquis. Investors were worried enough that Bayer's stock fell by as much as 5 percent.

But we'll only know more once the new study's details are unveiled at an upcoming conference. The early data is just headline info, not nitty-gritty stuff.

- read the Dow Jones story
- get more from Forbes 

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