(Updates company shares in sixth, seventh paragraphs.)
June 23 (Bloomberg) -- Pfizer Inc.’s and Bristol-Myers Squibb Co.’s experimental blood thinner apixaban prevented more strokes with less major bleeding than traditional treatment in patients with irregular heartbeats in a key study.
The results position apixaban, expected to trail two rivals in gaining approval, to leap into the lead in a $7 billion market for warding off strokes in patients with the condition known as atrial fibrillation, said Mark Schoenebaum, an analyst with ISI Group, in a note to investors. Pfizer and Bristol-Myers plan to file for regulatory approval in the U.S. and Europe by year’s end, the New York-based companies said yesterday in a statement summarizing the study’s data.
Apixaban will compete against Boehringer Ingelheim GmbH’s Pradaxa, approved last year, in the contest to replace the half- century-old drug warfarin, a sensitive medicine that requires regular laboratory tests to ensure patients get the proper dose. Xarelto, another rival from Bayer AG of Leverkusen, Germany, and New Brunswick, New Jersey-based Johnson & Johnson, is awaiting U.S. approval.
“Since apixaban looks very likely to be the only blood thinner with superior efficacy and safety, we think it could take as much as 50 percent” of the market for atrial fibrillation, Schoenebaum wrote. “At peak that represents worldwide sales of $3.5 billion” in the heart condition alone, and increase from a $1.4 billion estimate before yesterday’s data, he wrote.
Atrial fibrillation is the biggest single market for the new blood thinners, according to Schoenebaum. Apixaban, to be marketed under the brand name Eliquis, was approved in Europe last month to prevent clots after surgery to replace hips or knees, another major market for the medication.
Pfizer rose 37 cents, or 1.8 percent, to $20.65 at 4 p.m. in New York Stock Exchange trading. Bristol-Myers gained $1.59, or 5.7 percent, to $29.33, its biggest single-day increase in more than a year.
Bayer declined 6.3 percent to 54.40 euros at the close of Frankfurt trading, the biggest drop since March 2009 on concerns that the study results would harm the market for Xarelto.
Apixaban may offer the best of all possible drugs, said Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston, in a note to clients. Pfizer and Bristol-Myers are marketing powerhouses, the drug appears to be the best in the class and the market is untapped territory that could generate billions in sales, he said.
“Bristol-Myers/Pfizer should be able to claim superiority on efficacy to warfarin or aspirin with major bleeding rates superior to warfarin and comparable to aspirin,” Fernandez wrote. “With a marketing pedigree that includes the two biggest cardiovascular blockbusters, Pfizer with Lipitor and Bristol- Myers with Plavix, we believe BMY/PFE can deliver apixaban’s full potential.”
Apixaban has been shown effective in treating the minority of atrial fibrillation patients who aren’t candidates for warfarin, according to results published in the March 3 New England Journal of Medicine. It is better than aspirin in preventing strokes in these patients, the study found.
The new study, called Aristotle, compared twice-daily apixaban to warfarin in 18,206 patients with atrial fibrillation, according to a March 2010 description of the trial in American Heart Journal. The drug met its primary goal of showing apixaban was not inferior to warfarin in preventing strokes and clots that cause blood-vessel blockages.
It also was successful in two secondary goals: showing the drug was more effective than warfarin and leading to fewer cases of major bleeding, Pfizer and Bristol-Myers said in yesterday’s statement. Pradaxa, currently the drug’s biggest rival from closely held German drugmaker Boehringer, was more effective than warfarin with similar bleeding at a high dose and as effective as warfarin with less bleeding at a lower dose. Apixaban was more effective and safer, the companies said.
Spokesmen for Pfizer and Bristol-Myers declined to provide additional details about the study results. The findings will be presented at the European Society of Cardiology meeting in Paris in August.
--Editors: Andrew Pollack, Angela Zimm, Marthe Fourcade.
To contact the reporters responsible for this story: Robert Langreth in New York at firstname.lastname@example.org; Michelle Fay Cortez in Minneapolis at email@example.com
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