Pfizer Inc.’s and Bristol-Myers Squibb Co.’s experimental blood thinner Eliquis saved more patient lives than standard treatment in a study that may position the drug atop a more than $10 billion-a-year market.
Patients with an irregular heartbeat who took the drug, also known as apixaban, had an 11 percent reduced risk of dying versus those on warfarin, researchers said Sunday at the European Society of Cardiology’s conference in Paris. Eliquis prevented 21 percent more strokes than the older drug, with a 31 percent lower risk of major bleeding, a feared side effect of blood thinners.
Results of this caliber may mean that while the drug lags behind two rivals in the race to win approval in the U.S., it could still take up to half of the market, Christopher Schott, a New York-based analyst for JPMorgan Chase & Co., wrote in a note to investors before the data was public. Schott said a “best-case scenario” may add $1 billion in peak annual sales to the $2.8 billion he estimated Eliquis will generate by 2017.
“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 in New York and a member of the executive steering committee on the study, said in a telephone interview. “You can’t argue with these impressive results.”
For every 1,000 patients treated during the trial, the blood thinner prevented a stroke in six people, major bleeding in 15 people and death in eight people, investigators wrote in a New England Journal of Medicine article published to coincide with the presentation in Paris. Pfizer and Bristol-Myers said in June the results of the trial, called Aristotle, were positive but didn’t disclose the data. The two companies funded the study, which followed 18,200 patients with an irregular heartbeat called atrial fibrillation.
“The answer is crystal clear: patients will do better on this drug,” lead investigator Christopher Granger, of the Duke Clinical Research Institute, said in an interview at the conference. Lower cost is the only reason for patients to continue taking warfarin, he said.
Doctors had been eager for a replacement for warfarin because patients need regular blood tests to ensure they’re getting a safe, effective dose of the older drug.
The Pfizer and Bristol-Myers drug would compete with other warfarin-replacement pills. Boehringer Ingelheim GmbH’s Pradaxa was the first, approved last year. Bayer AG and Johnson & Johnson also have a candidate, Xarelto, due for regulatory review in the U.S. next month.
“There was a warfarin era, and there is now the modern era,” Michael Ezekowitz, vice president of the Lankenau Institute for Medical Research and the Heart Center in Wynnewood, Pennsylvania, told cardiologists at the conference today. Based on their trial results, both Pradaxa and Eliquis will help “millions of patients worldwide with atrial fibrillation,” he said.
The condition occurs when the upper chambers of the heart quiver rather than contract, allowing blood to pool and form into clots. More than 2.5 million Americans suffer from it and 11,000 die every year.
Pradaxa and Xarelto didn’t significantly extend patients’ lives in studies, though both showed a trend toward being able to do so, Jessica Mega, a cardiologist at Brigham and Women’s Hospital in Boston, wrote in an editorial published alongside the results in the journal today. Yet all three appear to be better than warfarin, Mega wrote.
Boehringer’s Pradaxa has the most to lose from good Eliquis results, Larry Biegelsen, a New York-based analyst for Wells Fargo Securities, wrote in a note to clients before the study was published. Bayer’s Xarelto was studied in a more high-risk group of patients than Eliquis or Pradaxa and could maintain a market niche because it’s a once-daily pill, Biegelsen said.
Warfarin is also once-daily. Both Eliquis and Pradaxa must be taken twice each day. The market for warfarin-replacement drugs is worth more than $10 billion annually, according to analysts at Leerink Swann & Co.
“It’s hard to pit the drugs against each other,” Ralph Brindis, senior adviser for cardiovascular disease at Northern California Kaiser Permanente, said of the new drugs in an interview. “I have to say though that the Aristotle trial is pretty darn impressive.”
Still, if a patient is stable on warfarin and doesn’t mind a monthly doctor’s visit for a blood test, there may be no reason to switch to a new, more expensive medicine, Brindis said.
Pfizer and Bristol-Myers plan to submit Eliquis for U.S. and European regulatory approval by year-end.
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