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Boehringer says Pradaxa sales exceed hopes

Tue, 29 Mar 2011 20:56 GMT

Source: reuters // Reuters

* Expects at least 180,000 U.S. Pradaxa patients mid-year

* Expects to convert at least one third of warfarin users (Adds details about Daiichi Sankyo, Portola drugs)

By Ransdell Pierson

NEW YORK, March 29 (Reuters) - Privately held drugmaker Boehringer Ingelheim said on Tuesday it expects at least 180,000 U.S. patients to be taking its recently approved Pradaxa blood clot preventer before midyear, twice the number counted in late January.

Company officials said in an interview about 1.6 million Americans now take the standard warfarin oral blood clot preventer for stroke prevention, and at least one-third of them will likely ultimately switch over to Pradaxa.

"I don't see why we shouldn't be able to get one third of them," said Wa'el Hashad, a Boehringer Ingelheim vice president who oversees the Pradaxa marketing campaign, when asked whether the company could capture that proportion of warfarin users.

"We continue to grow beyond the initial goals we set for ourselves, and you will see a doubling of patients even before mid-year," Hashad said, compared with the 90,000 U.S. patients taking Pradaxa in late January.

U.S. regulators approved Pradaxa in October after a 18,000-patient trial showed the pill was 35 percent more effective than warfarin in preventing strokes among patients with atrial fibrillation, a type of irregular heartbeat most common among the elderly. Moreover, patients taking the Boehringer drug had no greater risk of bleeding.

Warfarin has been the standard for preventing stroke in such patients since it was introduced in the mid 1950s.

But patients taking warfarin, which is sold by a number of generic drugmakers, must follow stringent diets and have frequent blood tests to make sure there is neither too little nor too much of the drug in their bloodstream. If too little, stroke prevention is reduced; if too much, they can be at high risk of bleeding, including brain hemorrhage.

With Pradaxa -- the first oral member of a family of drugs called direct thrombin inhibitors -- patients do not have to adhere to special diets or have to undergo blood monitoring.

"This was a large trial with compelling results, so Pradaxa has gotten a lot of attention," said John Smith, Boehringer Ingelheim's senior director for clinical development, who predicted far more doctors will prescribe Pradaxa in coming months.

Pradaxa has gotten a big head start as other drugmakers race to bring to market another class of promising blood clot preventers called Factor Xa inhibitors also meant to prevent stroke among patients with atrial fibrillation.

They include Xarelto, from Bayer AG <BAYGn.DE> and Johnson & Johnson <JNJ.N>, which has been awaiting U.S. approval for stroke prevention since January. Meanwhile, Bristol-Myers Squibb Co <BMY.N> and Pfizer Inc <PFE.N> are conducting late-stage trials of their promising pill called apixaban.

Japanese drugmaker Daiichi Sankyo <4568.T> in December said it had completed enrollment of more than 21,000 patients in a late-stage study of its edoxaban -- the largest trial ever conducted of a Factor Xa inhibitor.

Merck earlier this month returned to privately held Portola Pharmaceuticals rights to betrixaban -- which Merck once said had potential to be the "best in class" of the Factor Xa medicines.

Merck said it was giving up rights to betrixaban after determining it no longer fit its portfolio -- based on the drug's potential for success and costs to develop it.

Industry analysts speculated Merck's decision was based in part on the fact that betrixaban was behind rival drugs in development. Also it would have had had a tough time wresting sales away from the rival drugs, the analysts said. (Reporting by Ransdell Pierson; editing by Carol Bishopric)