Potential Effient rival recommended for approval

May 21, 2012

Johnson & Johnson and Bayer AG’s blood-thinner Xarelto should be approved to help prevent heart attacks and strokes in patients with a common condition, a U.S. regulatory report recommended.

The drug works in patients with acute coronary syndrome, which occurs when a blood clot blocks blood supply to the heart, Food and Drug Administration staff said Monday in a report ahead of a advisory panel meeting Wednesday on Xarelto. The agency is scheduled to decide on expanding use of the drug by June 29.

If approved for acute coronary syndrome, Xarelto would compete with London-based AstraZeneca Plc’s Brilinta and Indianapolis-based Eli Lilly and Co.’s Effient. Lilly sold about $300 million worth of Effient in 2012.

Acute coronary syndrome accounts for 1.2 million hospitalizations each year, according to New Brunswick, N.J-based J&J. The market for treatments for the condition may total more than $1 billion. The FDA approved Xarelto in November to prevent stroke in patients with irregular heartbeat. The medicine has been on the market since July to prevent blood clots in patients undergoing knee and hip surgeries.

“The benefit risk ratio for Xarelto appears to be favorable, predominantly because there is a reduction in” cardiovascular death “despite an increased risk of major and fatal bleeding,” reviewer Karen Hicks said in the FDA report.

Xarelto given at 2.5 milligrams reduced heart attacks and strokes 15 percent compared with placebo while resulting in a two-fold increase in fatal bleeding and three-fold increases in major bleeding, intracranial hemorrhage, hemorrhagic stroke and minor bleeding that indicated a hemorrhage, according to the report.

Les Funtleyder, a portfolio manager at Miller Tabak & Co., and Tony Butler, an analyst at Barclays Capital Inc. in New York, said they expect Xarelto to gain approval because of its ability to prevent death.

J&J’s drug “will probably be a market leader,” Funtleyder said. “All of these things have bleeding risks.”

J&J owns U.S. rights to the drug while Leverkusen, Germany- based Bayer sells the medicine in Europe. The drug would be taken twice daily in combination with aspirin and Plavix, made by Paris-based Sanofi and New York-based Bristol-Myers Squibb Co.

Xarelto is one of the medicines attempting to replace warfarin, which requires constant monitoring and dose adjustments to keep blood from getting too thin and putting patients at risk of severe bleeding. Xarelto’s sales are expected to reach $799 million in 2015, according to the average of four analysts surveyed by Bloomberg.

New York-based Pfizer Inc. and Bristol-Myers are awaiting a June 28 decision on their blood-thinner Eliquis in patients with an irregular heartbeat. Boehringer Ingelheim Gmbh, a closely held company based in Ingelheim, Germany, won approval in 2010 to sell its blood thinner, Pradaxa, for those patients.

Lilly shares were up 13 cents Monday morning, to $40.56 apiece.


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