The press release touting Pfizer (NYSE: PFE) and Bristol-Myers Squibb's (NYSE: BMY) atrial fibrillation drug makes the whole thing sound like an afterthought: "In addition, Eliquis met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin."
But those 26 words could be worth billions to Pfizer and Bristol-Myers Squibb. Yes, billions.
It's a three-horse race to replace warfarin: Eliquis, Boehringer Ingelheim's Pradaxa, and Xarelto from Bayer and Johnson & Johnson (NYSE: JNJ). There's data that shows Pradaxa is superior to warfarin, but it wasn't a blinded study -- patients knew which drug they were getting -- so it's not considered all that strong. Xarelto failed to beat warfarin in atrial fibrillation patients.
Pfizer and Bristol-Myers hedged their bets making non-inferiority to warfarin the primary endpoint with superiority as the secondary endpoint, which is the reason the duo didn't lead with the more important news. Proving that Eliquis is as good as warfarin -- and its nasty side effect of major bleeding -- would have been good enough to get Eliquis on the market. Topping warfarin on efficacy and safety should be enough to rocket past Pradaxa and Xarelto.
The companies plan on submitting marketing applications for Eliquis in the U.S. and Europe later this year, which would make it the third drug to make it to market. Being third to the party with ho-hum data would result in ho-hum sales for sure. With superior data -- assuming they live up to the hype of the press release -- Pfizer and Bristol-Myers can expect major sales from Eliquis.
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