Pfizer, Bayer Studies Show Clot Drugs Safe as Standard Therapy
Aug. 31 (Bloomberg) -- Pfizer Inc. and Bayer AG revealed study results today that may give their medicines a foothold in a $10-billion-a-year market to prevent clots that cause strokes and deadly lung damage. Bloomberg's Shannon Pettypiece reports. (Source: Bloomberg)
Pfizer Inc. and Bayer AG revealed study results today that may give their medicines a foothold in a $10-billion-a-year market to prevent clots that cause strokes and deadly lung damage.
The research provided evidence that Pfizer’s apixaban and Bayer’s Xarelto are as safe as existing therapy, which may ease concerns among doctors who are seeking a replacement for warfarin, a powerful and unwieldy blood thinner used for more than a half-century. Apixaban beat aspirin at preventing strokes in patients with irregular heartbeat, while Xarelto matched standard treatments for clots in the legs and lungs.
At stake is a share in a warfarin-replacement market that could reach $10 billion to $20 billion a year, according to an estimate from Seamus Fernandez, an analyst with Leerink Swann & Co. Doctors and patients will “insist” on using a replacement as soon as one is available for warfarin, which requires regular blood tests and can leave patients vulnerable to deadly clots or uncontrollable bleeding at too low or high a dose, said Ralph Brindis, president of the American College of Cardiology and a cardiologist at Oakland Medical Center in California.
“We’re getting pretty close to the holy grail in finding a replacement for warfarin,” Brindis said in an interview. “I don’t know which one is going to win or lose in that family, but the body of evidence is growing.”
Pfizer rose 5 cents, or 0.3 percent, to $15.91 at 4 p.m. in New York Stock Exchange composite trading, while partner Bristol-Myers Squibb Co. rose 23 cents, or 0.9 percent, to $26.08. Bayer rose 1.15 euros, or 2.4 percent, to 48.18 euros in Frankfurt trading, and partner Johnson & Johnson fell 28 cents, or 0.5 percent, to $57.02 in New York.
Boehringer’s Pradaxa
Boehringer Ingelheim GmbH may be the first drugmaker to win U.S. approval of a revolutionary alternative to warfarin, which is derived from rat poison. U.S. regulatory advisers will review Pradaxa, already approved in Europe to prevent clots following hip and knee surgery, on Sept. 20.
Pradaxa, apixaban and Xarelto interfere with the body’s own clotting mechanisms to minimize strokes, lung clots and extended leg clots, commonly at a risk of increased bleeding, Brindis said. Apixaban, which is still being tested, and Xarelto, which is approved in Europe for hip and knee surgery patients, appear to be effective and safe, perhaps safer than the current standard, he said.
Apixaban Results
Patients who took apixaban were 54 percent less likely to have a stroke or damaging clot than those who took aspirin in a study of 5,600 patients who couldn’t use warfarin, researchers said today at the European Society of Cardiology conference in Stockholm. Apixaban and aspirin showed a similar risk of major bleeding, a feared side effect of blood thinners, according to the study, dubbed Averroes after a 12th century Islamic philosopher.
“The use of aspirin will probably be reduced after this study,” said Harald Arnesen, a professor at Ullevaal University Hospital in Oslo.
Warfarin typically reduces the rate of stroke 40 percent more than aspirin, Larry Biegelsen, a New York-based analyst for Wells Fargo Securities, wrote in a note to investors on Aug. 30. That’s a less potent effect than apixaban showed in today’s trial.
Results from the larger 18,000-patient Aristotle study comparing apixaban with warfarin in patients with an irregular heartbeat called atrial fibrillation are expected in the first half of next year, Tim Anderson, a New York-based analyst with Bernstein Research, said today in a note to clients.
Xarelto Results
“Aspirin isn’t the recommended treatment simply because there’s significant amounts of clinical data that shows that in fact protection is greater on warfarin,” said Nick Turner, a London-based analyst at Mirabaud Securities, in a telephone interview today. “So exactly how well a drug compares to aspirin is probably not that significant.”
Xarelto matched the standard therapy of Sanofi-Aventis SA’s Lovenox plus warfarin at blocking blood clots in the lungs and legs, researchers said today in a study of more than 3,400 patients. Some 2.1 percent of those in the Xarelto group developed clots compared with 3 percent of people taking the older standard treatments.
Patients who took Xarelto were 33 percent less likely to develop either clots or major internal bleeding, Bayer said. The Leverkusen, Germany-based drugmaker is developing Xarelto with Johnson & Johnson. About 8.1 percent of patients in both treatment groups developed serious bleeding, the study found.
The company designed the study, dubbed Einstein-DVT, to see whether the once-a-day pill could match the existing therapies, which are “very, very effective,” said lead researcher Harry Bueller, of Academic Medical Center in Amsterdam.
Bayer’s Plans
Medicines to prevent clots after knee surgery or in the lungs and legs are a small part of the blood thinner market, said Flemming Oernskov, head of the women’s health and general medicine unit at Bayer. The much bigger market is in atrial fibrillation, Oernskov said in an interview.
Bayer has said it plans to present its trial on Xarelto versus warfarin in atrial fibrillation patients at the American Heart Association conference in November.
“We think that when all indications are there, we have all the trials and it has worked out well, it could be for us as a company over 2 billion euros in annual revenue,” the Bayer executive said. “You can imagine this market will be several factors higher than the 2 billion euros.”
To contact the reporter on this story: Naomi Kresge in Stockholm at nkresge@bloomberg.net; Chris Kay in London at ckay5@bloomberg.net
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