Bayer has now gotten European regulators to sign off on selling its stroke prevention drug Xarelto in Germany, barely a month after the FDA approved the drug for sale in the U.S.
The approval is a mixed bag, as Reuters points out.
On the one hand, Bayer estimates its drug will generate $2.7 billion in annual sales at the market peak for Xarelto, an anti-blood-clotting pill designed to be safer than the long-time blood thinner warfarin, and Germany is the biggest regional market in the European Union. Also, the global market for next-generation oral anti-stroke drugs could be as much as $20 billion, according to analysts cited by Reuters.
So what could possibly be wrong with this? Well, there's less of the pie for Bayer than you'd think, because the company will only receive up to 30% of U.S. sales of the drug due to its co-developing and marketing arrangement there with Johnson & Johnson ($JNJ). The U.S. pharmaceutical market is arguably the biggest, but Europe, by default, will be Bayer's most important for Xarelto.
Xarelto is a once-daily pill indicated to prevent strokes in patients with atrial fibrillation and also to combat deep vein thrombosis, Bayer said.
EU rivals include Boehringer Inglheim's Pradaxa, which one European marketing clearance in August. But the drug has caused some cases of fatal bleeding, Reuters said. Another competitor is coming: Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) are developing Eliquis, and an FDA decision on the drug is expected by March under a fast track status.
- here's the Reuters story
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