Bayer tanks after doubts over Xarelto
Leverkusen - It was a black Tuesday for Bayer. After rumours were leaked out that the FDA has doubts over the German pharmaceutical company's potential blockbuster Xarelto, the shares temporarily dropped as much as 17 percent. Until now, Bayer and its partner Johnson&Johnson expected substantial revenues from the drug to treat blood clotting in patients with atrial fibrillation. Xarelto was planned to get on the market in 2012 and reap yearly revenues of about €2bn.This schedule is now endangered. “There is insufficient information about the drug to determine whether it is safe for use with its proposed labelling,” the Food and Drug Administration said in a staff report released Tuesday. Bayer and J&J had already won approval on July 1 to market the drug for prevention of blood clots after knee or hip replacement surgery. An advisory panel of outside experts to agency will meet Sept. 8 to discuss the new use of the drug, chemically known as rovaroxaban. The FDA isn't required to follow the recommendations. If Xarelto enters the market, it will compete with Boehringer Ingelheim GmbH's Pradaxa, approved by the FDA for the heart patients in October, and Pfizer Inc. and Bristol-Myers Squibb Co.'s apixaban, known as Eliquis, now being tested in clinical trials.