Bayer, J&J anti-clot drug shines in stroke trial

By Reuters
Posted Nov. 15, 2010 at 9:25 a.m.

A once-daily pill being developed by Bayer AG and Johnson & Johnson was better at preventing stroke than standard treatment, with less risk of the most worrisome types of bleeding, researchers said on Monday.

The fuller picture for Xarelto could boost Wall Street global sales forecasts for the product — already as high as $5 billion a year — and make it a tougher-than-expected competitor for an up-and-coming crop of new blood clot preventers that must be taken twice a day.

Shares of Bayer jumped more than 5 percent in Frankfurt while J&J rose 1.2 percent in trading in New York after the release of the trial data.

Xarelto was 21 percent better able than the widely used but problematic drug warfarin to reduce strokes caused by a form of irregular heartbeat called atrial fibrillation that is common among the elderly, according to results presented at the annual meeting of the American Heart Association in Chicago.

Although that improvement was not considered statistically significant, researchers said Xarelto demonstrated a superior effectiveness with its lower risk for intracranial bleeding and hemorrhagic stroke — the most feared consequences of anti-clotting medicines.

Two weeks ago, the drugmakers announced general findings from the 14,000-patient trial called ROCKET AF, including that Xarelto was at least as good as warfarin in preventing strokes and had a similar overall bleeding risk.

On Monday, researchers said patients taking Xarelto were about one-third less likely to have intracranial bleeding, which includes strokes and other bleeding within the brain area. An estimated 41 percent reduced risk was seen for hemorrhagic stroke.

Researchers said no other stroke trial has ever enrolled such a high percentage of very sick patients. Sixty-two percent of patients had heart failure, 91 percent had hypertension and 39 percent had diabetes.

Bleeding into a critical organ was reduced by 31 percent, while the risk of fatal bleeding was cut in half. But Xarelto patients had bigger drops in hemoglobin and required more blood transfusions, the other two components of major bleeding.

“Arguably, for the components that physicians and patients care most about, Xarelto was significantly lower,” Peter DiBattiste, J&J’s head of cardiovascular medicine development, said in an interview at the heart meeting.

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