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Pfizer, BMS release bullish Eliquis results

by Ben Fidler | Published August 29, 2011 at 1:10 PM

Pfizer Inc. and Bristol-Myers Squibb Co. have released the full results of the study for their oral anti-coagulant drug, Eliquis, and the figures have reaffirmed analysts' predictions that the treatment will be the leading candidate in the race to replace Warfarin.

Pfizer and BMS said on Sunday, Aug. 28, that the results of the so-called Aristotle study, a Phase 3 trial that pitted Eliquis against Warfarin -- used to prevent heart attacks, strokes and blood clots -- showed that their drug was not only on par with Warfarin, but superior. Specifically, the drug tested 21% superior to Warfarin in reducing the risk of stroke or systemic embolism and 31% better in reducing the risk of major bleeding in patients experiencing atrial fibrillation, which is an irregular heart rhythm that increases the risk of stroke.

The numbers reaffirm analysts' predictions on Eliquis in June -- that it gives Pfizer and BMS, two drugmakers facing major patent expirations in the next year -- a big edge over Warfarin's two other replacements, Boehringer Ingelheim Corp.'s Pradaxa and Bayer AG and Johnson & Johnson's Xarelto.

"These numbers are best-in-class data," said Leerink Swann LLC analyst Seamus Fernandez. "We're thinking [Eliquis] is going to be the clear winner."

Fernandez points to Eliquis' numbers in preventing major bleeding when compared to Warfarin and the other replacements. While Eliquis was 21% superior to Warfarin, Xarelto tested 4% worse. And Pradaxa, the only drug of the three replacements that has already been approved by regulators, showed just a 7% reduction. With Warfarin itself a multibillion dollar producer every year, analysts such as Fernandez, Jefferies & Co.'s Jeffrey Holford and Barclays Capital's C. Anthony Butler believe Pfizer and BMS could see nearly $4 billion in annual sales from the drug. Fernandez estimates $4.2 billion in sales by 2017. Holford predicts $3.7 billion in peak annual sales, while Butler sees Eliquis grabbing 50% of the U.S. market share and $4.5 billion in annual sales by 2021.

By comparison, Holford wrote that Xarelto could bring in $2.8 billion annually.

Pfizer and BMS are expected to file applications for approval in the U.S., Europe and Japan by the end of the year.

Companies have been scurrying to replace Warfarin because of the potential market size. Fernandez, for one, calls Warfarin's target market the "biggest new market for the pharmaceutical industry" since cholesterol-lowering statins or angiotensin receptor blockers, which are used to control high blood pressure.

Warfarin has long needed an update given what Fernandez calls a "checkered profile." While its efficacy in stroke reduction is good, Warfarin requires constant monitoring and reacts to both other drugs and food, he said.

"These new drugs are more selective and don't have food interactions," he explains.

BMS and Pfizer signed a collaboration agreement to develop and commercialize Eliquis in 2007. Under the deal, Pfizer made an up-front payment of $250 million to BMS in May 2007 and agreed to fund 60% of all of Eliquis' development costs, with BMS taking care of the remaining 40%. BMS may get up to $750 million in additional milestone payments from Pfizer. The two will evenly share both the commercialization expenses and profits, according to regulatory filings.

The Aristotle study randomized 18,201 patients with atrial fibrillation from more than 1,0000 centers in some 40 countries. Each patient was given either Eliquis or a comparable amount of Warfarin, a more than 50-year-old drug that was initially sold as rat poison.

The trial results are a big boost to BMS, whose best-selling drug, blood thinner Plavix, will lose patent exclusivity in 2012. BMS recorded $6.7 billion in sales from Plavix in 2010, accounting for about one-third of its revenue, while co-marketer Sanofi-Aventis SA took in $2.7 billion. Pfizer's Lipitor, which brought in $10.8 billion in 2010, faces its own patent cliff in November.

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Ben Fidler

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