Pfizer, BMS unveil mega-blockbuster data on apixaban

Continuing its hot streak through the weekend, Pfizer ($PFE) and its partner Bristol-Myers Squibb ($BMY) posted promising late-stage data for apixaban, a bloodthinner with mega-blockbuster potential. In a clinical trifecta, investigators reported that a major Phase III study comparing apixaban with warfarin demonstrated that the experimental drug reduced the risk of stroke or systemic embolism by 21%, major bleeding by 31%, and mortality by 11% among patients suffering from atrial fibrillation.

"You now have a drug that is not only more effective but more safe," Jack Ansell, chairman of the department of medicine at Lenox Hill Hospital, told Bloomberg. "You can't argue with these impressive results."

The developers aren't likely to face much flak from the analysts. Several days ago Reuters' Ben Hirschler noted that a new bloodthinner which demonstrated a significant reduction in mortality could snatch half of a $9 billion market. That combo of data on safety and efficacy may well leave Pfizer with the lead position in a multibillion-dollar market, even if it does arrive late to the party. Pradaxa from Boehringer Ingelheim was approved last year while Xarelto from Bayer and J&J is up for review later this year. Researchers noted that in the study the drug prevented a stroke in 6 of every 1,000 patients, major bleeding in 15 and the death of 8.

"The risk for stroke in patients with atrial fibrillation is a major public health concern in an aging population," said Dr. Christopher B. Granger, professor of medicine at Duke University Medical Center and the lead investigator of the study. "We are therefore encouraged by the outcome of the ARISTOTLE trial, which showed that apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding and mortality."

Apixaban, which will be sold as Eliquis if it wins approval, is an oral Factor Xa inhibitor.

- see the Pfizer release
- here's the story from Bloomberg