Boehringer Ingelheim Chief Executive Andreas Barner says he expects the drug company’s profits to rise by a “high-single-digit percentage” this year and to continue to climb in 2013 thanks to new blockbuster drugs, including the blood thinner Pradaxa. Blockbuster status is defined as generating annual sales of $1 billion or more.
Pradaxa (dabigatran) is the first anticoagulant in more than five decades to be approved by the Food and Drug Administration (FDA) since warfarin (Coumadin). It is indicated for the prevention of strokes in patients with atrial fibrillation, a type of irregular heartbeat that can cause strokes.
Pradaxa was presented as a safer alternative to warfarin, a drug that requires regular monitoring because of the bleeding risk.
Shortly after Pradaxa’s approval in October 2010, reports of serious bleeding events with the drug began surfacing. According to the Institute for Safe Medication Practices, 856 complaints were made to the FDA about Pradaxa during the second quarter of 2011. Of those complaints, 117 involved patient deaths and 511 involved cases of hemorrhage.
Unlike warfarin, there is no antidote for Pradaxa. When bleeding events occur, generally in the gastrointestinal tract or in the brain, doctors have few options for treating the bleed.
Despite the concerns, Boehringer says Pradaxa is preforming brilliantly in the sales realm. Pradaxa alone increased sales EUR629 million in 2011.