Pfizer Inc is voluntarily recalling its drug to treat a life-threatening lung condition and will end ongoing studies of the pill, after it was linked to potentially deadly liver toxicity.
The European Medicines Agency on Friday said on its website that the modest-selling drug to treat pulmonary arterial hypertension, called Thelin, was withdrawn due to "new information on two cases of fatal liver injury."
Pfizer spokesman Curtis Allen said Thelin, which is not sold in the United States, is being voluntarily recalled from Europe, Canada and Australia after being linked to a new liver complication "that occurs rarely and unpredictably in patients."
"The decision was based on a review of emerging safety information and post-marketing reporting," said Allen, referring to reports by doctors that have prescribed the medicine.
Thelin and similar medicines already carry warnings of elevated liver enzymes, a marker for potential liver damage. But the new liver risk for Thelin now suggests its overall risks outweigh its potential benefit, Allen said.
Pfizer, the world's biggest drugmaker, whose chief executive Jeffrey Kindler abruptly quit on Sunday, scrapped U.S. trials of Thelin among patients with pulmonary arterial hypertension (PAH).
Such patients have elevated blood pressure in lung arteries and veins that cause shortness of breath and other symptoms which can lead to heart failure and early death.
About 1,100 patients have taken Thelin since it was introduced in Europe in 2006 and in Australia and Canada the following year.
Pfizer in 2008 paid $195 million for the company that developed the product, Encysive Pharmaceuticals, even though the U.S. Food and Drug Administration had repeatedly rejected the drug for lack of efficacy.
Pfizer had been counting on the U.S. studies to ultimately prove its worth. The bad bet is the latest in a long string of setbacks for Pfizer, whose own laboratories have not generated any big-selling drugs for more than a decade, despite having the industry's biggest research budget.
Thelin garnered sales of $44 million in the first nine months of 2010, making it a small product for Pfizer.
It competes with Tracleer, a drug made by Actelion that had sales of $1.4 billion in 2009. Actelion has been rumored as a potential takeover candidate, with biotechnology company Amgen Inc considered a likely acquirer.
ReutersLast Mod: 11 Aralık 2010, 11:03