Daiichi Sankyo Co. (4568)’s experimental blood thinner edoxaban was as effective and less risky than standard treatment warfarin in a study that may position the Japanese company to compete with drugmakers including Pfizer Inc., Johnson & Johnson (JNJ) and Bristol-Myers Squibb Co. (BMY)
The 8,240-patient study found that a once-daily edoxaban pill given after initial heparin therapy was equivalent to the generic medicine warfarin at preventing new blood clots in patients who have had clots in a vein or lung. Patients who took edoxaban had significantly less bleeding, a feared side effect of blood thinners, than did patients on warfarin.
The results may help Daiichi Sankyo join the race to replace warfarin, a half-century-old therapy that requires close monitoring to avoid side effects such as severe bleeding that can be life-threatening.
“The bar is high, but if we look at analogous areas like the development of ACE inhibitors” to treat high blood pressure, “there was scope for the development of several,” Keith Fox, professor of cardiology at the Center for Cardiovascular Science at the University of Edinburgh, said in an interview before the results were released.
Fox is chairman of the program committee for the European Society of Cardiology’s meeting in Amsterdam, where the data were announced today. The study was also published online today in the New England Journal of Medicine.
Daiichi Sankyo is seeking to offset a drop in sales when its best-selling Benicar hypertension drug loses patent protection in 2016 with edoxaban and another anti-clotting treatment called Effient, which was approved in the U.S. in 2009.
Benicar generated 258.8 billion yen ($2.6 billion) for the year ended March for Daiichi Sankyo, or 26 percent of its total sales.
Today’s four-year-long study, dubbed Hokusai-VTE, is part of the last stage of patient trials generally required for regulatory review. Patients were given edoxaban or warfarin for as long as 12 months after being diagnosed with a blood-clotting condition called venous thromboembolism.
Edoxaban caused less bleeding across a broad range of patients, including those with severe blockages in the arteries of the lungs, the researchers said.
In venous thromboembolism, clots form in veins deep in the body, often in the legs. The clots can then break off and travel into the lungs, causing a potentially deadly pulmonary embolism.
From 300,000 to 900,000 people in the U.S. are affected by VTE each year, according to the Centers for Disease Control and Prevention in Atlanta. Almost half of the conditions occur either during or soon after discharge from a hospital stay or surgery and an estimated 60,000 to 100,000 Americans die of the illness each year.
Daiichi Sankyo is also testing the drug in patients with a heart rhythm disorder called atrial fibrillation, to prevent blood clots from forming in the heart. If it’s approved in both groups of patients, sales of edoxaban are expected to reach 40 billion yen by the year ending March 2018, according to SMBC Nikko Securities Inc.
“Edoxaban will face intense competition when it reaches the market,” Yasuhiro Nakazawa, a health-care analyst at SMBC Nikko in Tokyo, said in a telephone interview before the study results were published. “Patients and doctors don’t seem to switch brands once they are on medication, so it’ll be a slow start for Daiichi Sankyo.”
Edoxaban will compete with Boehringer Ingelheim GmbH’s Pradaxa, J&J and Bayer AG (BAYN)’s Xarelto, and Pfizer and Bristol-Myers Squibb’s Eliquis.
“The important point for the VTE trials is the safety profile of the drug, how it can minimize the risk of major hemorrhage,” SMBC Nikko’s Nakazawa said. Eliquis has a good safety profile, Nakazawa said.
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