AstraZeneca Plc is expanding studies of its blood-thinner Brilinta to patients with peripheral artery disease in an attempt to take more market share from Plavix, the world’s second-best selling drug, and its generic competitors.
Brilinta will be compared with clopidogrel, the generic form of Plavix, in 11,500 patients who are 50 or older and have symptoms of the disease, the U.K.’s second-biggest drugmaker said in a statement today. Patients will receive either 90 milligrams of Brilinta twice daily or 75 milligrams of clopidogrel once daily in the trial, called Euclid.
AstraZeneca is looking for new uses for the drug as Brilinta faces competition from a generic form of Plavix. Brilinta sales may reach $502 million by 2014 from $21 million last year, according to the average estimate of analysts surveyed by Bloomberg.
Euclid will be part of a long-term trial for Brilinta called Parthenon, which will include 51,000 patients worldwide and study the drug’s use, the company said. The first trial was Plato, which compared Brilinta with Plavix, made by New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi, in patients at risk of artery-blocking clots that can cause heart attacks and severe chest pain.
The Food and Drug Administration cleared Brilinta a year ago for use by patients with severe chest pain or heart attack history to cut the risk of heart attacks, strokes and death. Brilinta’s label must include a boxed warning, the agency’s strictest caution, about a risk of bleeding and a reduction in the drug’s effectiveness if taken with more than 100 milligrams of aspirin a day. The drug was approved in Europe in December 2010 under the name Brilique.
Peripheral artery disease affects about 27 million people in Europe and North America and patients are at high risk of heart attacks and strokes, the company said in today’s statement. Information about Parthenon will be presented at the European Society of Cardiology Congress between Aug. 25 and Aug. 29 in Munich, Germany.