Bayer’s Xarelto Wins EU Drug Panel Backing for Added Uses
Bayer AG (BAYN)’s Xarelto won the backing of a European drug advisory panel for use in irregular-heartbeat patients, putting the blood thinner in line for approval in a market that may reach $9 billion in annual sales worldwide.
The Committee for Medicinal Products for Human Use also recommended Xarelto to treat deep vein thrombosis, or clots in the legs or lungs, the European Medicines Agency said in a statement on its website today.
Bayer and its U.S. marketing partner Johnson & Johnson (JNJ) are battling Pfizer Inc. (PFE), Bristol-Myers Squibb Co. (BMY) and Boehringer Ingelheim GmbH to sell a replacement for warfarin, an old and difficult-to-use blood thinner for people with the most common type of abnormal heart rhythm. A U.S. regulatory panel this month backed the Bayer drug for atrial fibrillation against the recommendation of Food and Drug Administration workers.
“It looks like a smoother ride in Europe than in the U.S.,” Alistair Campbell, an analyst with Berenberg Bank, said in a telephone interview today. “Now it all comes down to marketing.”
Bayer expects a decision from the European Commission during the fourth quarter, the Leverkusen, Germany-based company said in an e-mailed statement. In the U.S., the FDA is scheduled to decide whether to approve Xarelto by Nov. 5 and doesn’t have to follow the recommendation.
Bayer rose 7.1 percent, the most since March 20, 2009, to close at 39.42 euros at 5:30 p.m. in Frankfurt trading.
Bayer already sells Xarelto in Europe, where it won approval in 2008 for use in knee- and hip-surgery patients.
The market for warfarin replacements may reach $7 billion to $9 billion a year, according to analysts for ISI Group and Leerink Swann & Co.
The irregular heartbeat patient group may contribute about 600 million euros ($811 million) of an estimated 2.2 billion euros in peak Xarelto sales, Daniel Wendorff, a Frankfurt-based analyst for Commerzbank AG, wrote in a note to clients before the decision. Wendorff has a “buy” recommendation on Bayer shares.
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