By Michelle Fay Cortez
Aug. 31 (Bloomberg) -- AstraZeneca Plc’s experimental clot- fighting drug Brilinta prevented 16 percent more heart attacks, strokes and deaths than standard therapy with Sanofi-Aventis SA’s and Bristol-Myers Squibb Co.’s Plavix in a study.
Brilinta’s potency didn’t cause more episodes of serious bleeding, a common complication seen with drugs that ward off heart conditions by preventing blood clots from developing, the research showed. The findings position Brilinta to rival Plavix, the second-biggest selling medicine in the world with almost $10 billion in annual revenue, for millions of patients suffering from heart attacks or severe chest pain.
About 1.3 million Americans are hospitalized each year with heart attacks and chest pain known as acute coronary syndromes. While aspirin and Plavix have lowered their subsequent health risks, cardiovascular disease remains the leading cause of death worldwide. Death from any cause was also significantly lower in patients taking Brilinta, according to the results of the study known as Plato.
“I think this will become the new standard of care,” said Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and a past president of the American College of Cardiology, in an interview. “It’s more rapid, more effective and it appears to be safer” than Plavix and another competitor, Effient, from Eli Lilly & Co. of Indianapolis and Daiichi Sankyo Co. of Japan. “I don’t think they could have done much better than they did in this trial.”
North America
The study included more than 18,000 patients in 43 countries. Those in North America may have done worse on Brilinta, a finding researchers couldn’t explain. That raised questions among analysts about future sales in the U.S.
“The North American market is such a big issue in terms of sales,” said Michael Leacock, an analyst at Royal Bank of Scotland in London. “This North American subgroup leaves a little more room for debate.”
While analyst estimates are sure to rise for Brilinta’s sales, it might not be enough to make the company’s shares more attractive, Leacock said in an interview. AstraZeneca faces lower-priced competition on products that generate 62 percent of sales by 2014.
“It certainly seems to be a more competitive product than we would have expected,” Leacock said. “The consensus is already at $1 billion a year. Even if you add another $1 billion to AstraZeneca’s sales in 2013, I’m not sure it makes a large difference to the investment case for AstraZeneca.”
AstraZeneca shares have gained 1.2 percent this year, compared with a 2.1 percent increase in the 17-member Bloomberg Europe Pharmaceutical Index. Sanofi, which is set to lose patent protection on Plavix in 2011, has risen 6.1 percent.
Eagerly Anticipated
The trial, funded by London-based AstraZeneca, was one of the most eagerly anticipated findings presented at the European Society of Cardiology meeting in Barcelona this week. It was simultaneously published in the New England Journal of Medicine yesterday. The researchers reported an unexpected 22 percent reduction in the overall risk of early death from any cause.
“Bristol-Myers Squibb and Sanofi-Aventis have not had an opportunity to fully analyze the results of Plato,” Laura Hortas, a spokeswoman for New York-based Bristol-Myers, said yesterday in an e-mail. Plavix is approved for use in a broad group of patients with cardiovascular conditions, while the Brilinta trial focused only on patients who suffer from acute coronary syndromes including heart attacks and chest pain, Hortas said.
Seeking Approval
The U.K. drugmaker plans to file for approval of Brilinta in the fourth quarter in Europe and the U.S. and hopes to begin selling it next year, said Gunnar Olsson, AstraZeneca’s head of cardiovascular therapy.
Brilinta, Plavix and Effient all work by preventing platelets from clumping together in the blood to form clots. Plavix and Effient, which was approved this year in Europe and the U.S., last for the life of the platelet, or about a week, and are given once a day. Brilinta needs to be taken twice daily, and patients are likely to comply with that regimen, said David Snow, AstraZeneca’s vice president of cardiovascular global marketing.
“You’ve had a heart attack,” Snow said in an interview in Barcelona. “You’re certainly going to be motivated to avoid another one.”
About 30 percent of patients don’t respond well to Plavix. Brilinta’s effects wear off in a few days, making surgery easier for patients who need it.
‘Huge Conundrum’
One in 10 patients rushed to the hospital with chest pain or heart attacks actually need by-pass surgery, said Christopher Cannon, a cardiologist at Brigham and Women’s Hospital in Boston. If they are given Plavix or Effient, they must wait five days before getting the surgery, he said.
“It’s a huge conundrum, a headache for doctors, hospitals and patients,” he said in a telephone interview. “This opens the door. It’s a neat differentiating factor that could open up treatment options.”
In the study, 9.8 percent of patients taking Brilinta for a year after being treated for a heart attack or worsening chest pain suffered another heart attack or stroke, or died from vascular disease, compared with 11.7 percent of those given Plavix. Overall, 4.5 percent of Brilinta patients died from any cause, significantly fewer than the 5.9 percent of Plavix patients who died.
Major Bleeding
The rates of major bleeding were similar between the two groups, occurring in 11.6 percent of those on Brilinta and 11.2 percent of those on Plavix. Fatal bleeding in the brain was more frequent in those given Brilinta, while fatal bleeding in other areas was more common with Plavix. Brilinta was linked to more serious bleeding in the brain and stomach of patients who didn’t undergo bypass surgery, the study found.
“You have to keep the big picture,” said Jay Horrow, AstraZeneca’s executive director of clinical development. “Ticagrelor had fewer patients with fatal bleeding overall than clopidogrel.”
To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net
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