Friday, September 17, 2010

Clot Wars contd. - load up!

The market for new blood thinners including Johnson & Johnson and Bayer AG’s Xarelto could eventually reach $12 billion to $15 billion a year, Bayer Chief Executive Officer Werner Wenning said.

Safety and effectiveness will determine how the anti- clotting pill fares against rivals from Pfizer Inc., Bristol- Myers Squibb Co. and Boehringer Ingelheim GmbH, Wenning said at a dinner with journalists at Bayer’s headquarters in Leverkusen, Germany. Xarelto is already competing “very well” against Boehringer’s Pradaxa in hip and knee surgery patients outside the U.S., he said.

“It’s a very important asset,” Wenning said. Xarelto sales could exceed 2 billion euros ($2.6 billion) a year, he said. Wenning didn’t say when he expects the market for blood- thinners to reach his projected peak.

Family owned German drugmaker Boehringer is ahead in the race for U.S. approval of the first alternative to warfarin, a powerful and dangerous blood thinner derived from rat poison. The Food and Drug Administration is scheduled to issue preliminary findings tomorrow on whether Pradaxa should be approved to prevent strokes caused by blood clots in patients with an irregular heartbeat, a use that makes up the majority of the warfarin-replacement market. An advisory panel meets to discuss the drug on Sept. 20.

Positive Recommendation

The panel is likely to recommend Pradaxa be approved, Emmanuel Papadakis, a London-based analyst for Collins Stewart, wrote in a note to investors on Sept. 13.

Doctors rely on warfarin and aspirin to ward off strokes among 2.2 million Americans with atrial fibrillation, an irregular heartbeat that prevents the organ from properly pumping blood out of its upper chamber. The resulting clots may cause a stroke if they get stuck in the artery to the brain.

Bayer has said it will present results of a study of Xarelto in atrial fibrillation patients at the American Heart Association meeting in November. The German drugmaker said Aug. 31 it will seek U.S. regulatory approval next year for Xarelto for hip and knee surgery patients, after the FDA asked for more information about the drug at its initial review in May 2009.

Bristol-Myers and Pfizer are expected to have results next year for apixaban, a third warfarin-replacement candidate for irregular heartbeat patients. The experimental drug beat aspirin at preventing strokes in a study released last month.

Posted via email from Jack's posterous

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