Pfizer/BMS clot drug expected to best Pradaxa, Xarelto

Look out, warfarin-alternative market. Eliquis may be the last to hit, but it may hit the hardest. Some much-anticipated data came out at the European Society of Cardiology conference over the weekend, showing the Pfizer/Bristol-Myers Squibb drug beat standard warfarin therapy at reducing stroke or systemic embolism in patients with atrial fibrillation--with less risk of bleeding to boot. Plus, the risk of death from any cause was cut by 11%, a statistically significant result that's sure to make it into Eliquis' marketing campaigns.

So, with this data from the Aristotle trial, Pfizer ($PFE) and Bristol-Myers ($BMY) can tout their drug as the only new-generation anticoagulant to surpass warfarin in both efficacy and safety. And it's the first to show a statistically significant reduction in deaths, Forbes notes. Boehringer Ingelheim's Pradaxa proved better than warfarin at stroke-prevention, but the bleeding risk was about the same. And Xarelto from Bayer and Johnson & Johnson ($JNJ) basically matched the older drug at both. Pradaxa is FDA- and EMA-approved for stroke prevention, while Xarelto has a clot-prevention indication, and the partners expect to hear on its stroke-prevention app soon.

Pfizer and BMS will certainly roll out a major marketing push, assuming Eliquis gets FDA approval to launch. But this data has experts talking up the drug already, even before the companies have asked FDA for the indication. "It's a remarkable achievement," said Dr. Valentin Fuster, a past president of American and world heart associations, who was not involved with the trial, told the New York Times. "This is one of the most significant advances in cardiovascular medicine in the last [5] years, no question." And as the study leader tells Reuters, "It gives a lot of confidence when you see a drug that reduces mortality. That's another feather in the cap."

Analysts are also hailing Eliquis, predicting it will easily take the lead position in this anticoagulant market, which is expected to top $10 billion. Leerink Swann's Seamus Fernandez figures Eliquis will top the new class of drugs with $4.2 billion in sales by 2017. Tony Butler of Barclays pegs peak sales at more than $5 billion, the Wall Street Journal reports. Mark Schoenebaum of ISI Group predicts Eliquis will get 60% of the market.

- see the release from Pfizer and BMS
- check out the Forbes story
- read the NYT piece
- get more from Reuters
- see the Bloomberg coverage
- check out the WSJ story