Daiichi Sankyo Co. (4568)’s edoxaban, the latest in a new group of blood thinners aimed at replacing warfarin, was found to be as effective as the drug that has been the standard of care for 60 years, in a study.
Research presented today at the meeting of the American Heart Association in Dallas showed edoxaban was as good as warfarin at preventing embolisms and strokes in patients with abnormal heart rhythms. It was also found to be safer, with fewer incidents of serious bleeding.
The Tokyo-based drug maker’s edoxaban, if approved, will enter a field that already has similar treatments sold by Johnson & Johnson (JNJ), Boehringer Ingelheim GmbH, and Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY) Projected by analysts to be capable of generating initial annual sales exceeding $1 billion, demand has been slow. Edoxaban’s data looks similar to that of competitors and it faces the same challenges, said Robert Harrington, the chairman of the department of medicine at Stanford University School of Medicine.
“There’s a comfort with warfarin, we’ve used it a long time,” Harrington, who is chairman of the AHA scientific sessions, said in a telephone interview with reporters. “Although it’s a drug we love to bash, it’s the drug we know.”
Eliquis, sold by Pfizer and Bristol-Myers, was projected to lead the class of new drugs, based on its better effectiveness data. Before it was introduced, Wall Street analysts projected $1 billion in sales by 2014 for New York-based Pfizer, which splits sales of the medicine with Bristol-Myers, also based in New York. Analysts surveyed by Bloomberg now estimate about $270 million next year, just over a quarter of previous expectations.
Pfizer shares fell 1.1 percent to $31.66 at 4 p.m. New York time. Bristol-Myers rose less than 1 percent to $51.98. J&J increased less than 1 percent to $94.86.
Sales of the drugs probably won’t improve suddenly, even with the addition of new data, said Judson Clark, an analyst with Edward Jones & Co. “I struggle to remember slow ramps that all of a sudden take off,” he said in a telephone interview. “Eliquis may be a solid drug, but it may not be the resounding success everyone thought.”
Doctors may be reluctant to switch existing patients onto the new drugs. Warfarin relies on a network of clinics to run blood tests and monitor patients to make sure patients can clot enough, just not too much. It’s an infrastructure patients and doctors have gotten used to and may be difficult to displace, Harrington said.
“The absolute risk reduction is small” on the new drugs compared to warfarin, said Jeffrey Weitz, a professor at McMaster University’s Department of Medicine in Hamilton, Ontario. “If a patient is stable on warfarin, I don’t see a huge need to switch them.”
Edoxaban’s data, from the last of three stages of testing generally required for regulatory approval, were also released today by the New England Journal of Medicine to coincide with the heart association meeting in Dallas. In a trial of 21,105 patients, edoxaban was found to be at least as good as warfarin at preventing strokes and blood clots. It also had lower rates of major bleeding, a complication of blood thinners.
“The data are fairly lackluster,” said Timothy Anderson, an analyst with Sanford C. Bernstein & Co. He said he expects edoxaban to be approved by regulators, though, and potentially gain a partner such as Merck & Co. or AstraZeneca Plc for sale in the U.S. and Europe, where Daiichi gets about 30 percent of its sales.
Merck and AstraZeneca “have a cardiovascular presence and need new products,” Anderson said in a note to clients.
In the study, patients with atrial fibrillation, or abnormal heart rhythm, were given warfarin or one of two doses of edoxaban. In warfarin patients, 1.50 percent had a stroke or clot, compared with 1.18 percent on the highest dose of edoxaban and 1.61 percent on the lowest. There was also less bleeding: 3.43 percent of warfarin patients had a major bleed, versus 2.75 percent on the high dose of edoxaban and 1.61 percent on the low dose. Major bleeding includes life-threatening bleeds, intestinal track bleeds and inside-the-skull bleeding.
There were fewer deaths among patents on edoxaban than on warfarin, the study found. In a year, 8.11 percent of warfarin patients died, compared to 6.79 to 7.26 percent of patients on Daiichi’s doses of the drug.
Glenn Gormley, Daiichi’s head of research and development and its U.S. business, said the addition of the edoxaban data, plus giving doctors the option of two different doses, might help expand the market. “There’s now an overwhelming amount of data,” he said. “We hope physicians understand that message.”
Daiichi’s pill is taken once a day, like J&J’s Xarelto. Eliquis is twice a day, as is Boehringer Ingelheim’s Pradaxa.
Gormley wouldn’t comment on how or whether Daiichi would attempt to compete against the other companies on price, though its sales force, or other factors.
Xarelto is capturing the most new prescriptions now, according to data compiled by Bloomberg, about six times as many per week as Eliquis.
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