Stroke Pill Sales May Surge With Pfizer, Bayer Challenges to Boehringer
By Shannon Pettypiece, Naomi Kresge and Michelle Fay Cortez - Aug 29, 2010 6:01 PM ET
Boehringer Ingelheim GmbH may be the first drugmaker to win U.S. approval of a revolutionary alternative for preventing strokes. It likely won’t be the last.
Pfizer Inc., the world’s biggest drugmaker, and Bayer AG will present data at a medical meeting tomorrow on pills racing to overtake Boehringer’s Pradaxa, which U.S. regulatory advisers will review Sept. 20. The prize: a bigger stake in a blood- thinner market that may be worth $10 billion to $20 billion a year, said Seamus Fernandez, an analyst with Leerink Swann & Co.
Positive findings for Pfizer and Bayer may put their pills in line to replace warfarin, a 65-year-old drug that can cause dangerous bleeding at high doses and deadly blood clots when too little is given. Pradaxa was more effective than warfarin at preventing strokes in atrial fibrillation patients, a study last year found. Research tomorrow will give clues on whether the Pfizer and Bayer pills are as good as, or better, than Pradaxa.
“Pradaxa has set a pretty high bar,” said Deepak Bhatt, chief of cardiology at the VA Boston Healthcare System. “It showed superiority. That is really a tough threshold that has been set in terms of apixaban and Xarelto.”
Pfizer, based in New York, rose 19 cents to $16.09 in New York Stock Exchange composite trading at the 4 p.m. close on Aug. 27. Bristol-Myers Squibb Co., also of New York, gained 27 cents to $26.12. Johnson & Johnson, of New Brunswick, New Jersey, increased 34 cents to $57.60, and Leverkusen, Germany- based Bayer climbed 32 cents to 47.15 euros in Frankfurt trading.
Drug Partnerships
Pfizer is partnering with Bristol-Myers on apixaban, while Bayer has teamed with J&J on Xarelto. Boehringer, based in Ingelheim, Germany, is the world’s biggest family-owned drugmaker and isn’t publicly traded.
Doctors now rely on aspirin and warfarin, a powerful but difficult-to-control medicine crafted from rat poison, to help prevent strokes in 2.2 million Americans with an irregular heartbeat, a condition also known as atrial fibrillation, Bhatt said. For patients at risk for developing clots in the leg or veins deep within the body as the result of other conditions, physicians use the generic drug heparin or Sanofi-Aventis SA’s Lovenox, with 3.08 billion euros ($3.9 billion) in 2009 sales.
All these drugs, though, have flaws making them difficult and dangerous to use, Bhatt said.
Tomorrow’s data, to be presented at the European Society of Cardiology meeting in Stockholm, will provide early insight into whether apixaban or Xarelto can match last year’s finding on Pradaxa, said Tony Butler, an analyst at Barclays Capital in New York, in an Aug. 25 note to clients.
Positive Results
Analysts are expecting positive results from Pfizer and Bristol-Myers’s product after the companies stopped their study comparing apixaban to aspirin ahead of schedule when an early analysis showed it cut the rate of strokes and certain clots, said Leerink Swann’s Fernandez, in an Aug. 20 report.
Apixaban may have trimmed the relative risk of having a stroke in the study by 38 percent, compared with aspirin, Fernandez said in a June report after the study was halted.
For Pfizer and Bristol-Myers, getting apixaban to market is critical as they brace for generic competition to their top- selling pills. Next year, Pfizer will start losing the majority of revenue for its cholesterol pill Lipitor, the world’s biggest drug with $11.4 billion in sales last year. The company has had a string of research setbacks this year, halting late-stage testing on four medicines.
Bristol-Myers is expected to face generic competition in 2012 for its anti-clotting drug Plavix, the world’s second-best selling medicine generating $6.1 billion last year for Bristol- Myers. It markets the drug with Paris-based Sanofi.
Einstein
The Bayer trial, dubbed Einstein-DVT, found that Xarelto was as effective as the standard therapy of Lovenox plus warfarin at preventing clots in the lungs and legs, the company said on Aug. 4. Investors will be looking at the specific bleeding rates when the full results of the study are presented tomorrow to determine how it compares to Pradaxa, Butler said.
Boehringer has said it expects approval of Pradaxa for atrial fibrillation patients later this year or early next year. Bayer has said it will request regulatory approval for Xarelto in both deep vein thrombosis and atrial fibrillation by the end of the year.
Pfizer’s apixaban may not come to market in the U.S. until 2012 as the company waits for results from a larger 18,000- patient study of atrial fibrillation patients comparing apixaban with warfarin, said Deutsche Bank analyst Barbara Ryan. The results from that study should be presented early next year, she said.
Sold in Europe
Both Xarelto and Pradaxa are sold in Europe, mainly to prevent blood clots from forming after hip and knee surgery. European regulators may approve apixaban next year for blood clots following surgery, Ryan said in a July 13 note to clients.
Pfizer and Bristol-Myers’s study to be presented tomorrow, dubbed Averroes, compared apixaban to aspirin for preventing strokes in patients with atrial fibrillation who couldn’t tolerate or chose not to take warfarin. Almost half of atrial fibrillation patients choose aspirin over warfarin because it has a lower risk of bleeding, fewer drug interactions and requires less monitoring, said Bhatt.
Atrial fibrillation means the heart doesn’t properly pump blood out of its upper chamber, allowing it to pool and clot, according to the American Heart Association. A stroke can result if part of that clot breaks off and gets lodged in the artery to the brain.
“Physicians and patients are sick of warfarin and there is a lot of hope of not having to deal with it anymore,” Bhatt said. “If something comes along that is as good or better than warfarin, that would be a very big improvement.”
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