AstraZeneca Plc, facing expiring patents on its top-selling products, moved closer to winning U.S. approval for a blood thinner to rival Plavix, the world’s second-biggest drug.
Outside advisers to the Food and Drug Administration voted 7-1 yesterday in favor of using the AstraZeneca’s Brilinta to reduce the risk of heart attacks, strokes and death in patients with severe chest pain or earlier heart attacks. The panel said concerns that U.S. study participants did worse on the drug than people in other countries may be the result of chance and could be examined in a future trial after the drug is approved.
Brilinta sales could reach $1.47 billion by 2016, according to the average estimate of three analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second biggest drugmaker, needs to replenish revenue over the next four years as patents expire on top-sellers Nexium, for heartburn, and the antipsychotic Seroquel, the generators of a combined $9.83 billion in 2009.
“From a commercial perspective, I do see a higher hurdle to capture share in the U.S.,” said Amit Roy, an analyst at Nomura International and cardiac surgeon, in a telephone interview yesterday from London. He said he anticipates that the FDA will approve the drug based on the overall data.
American depositary receipts of London-based AstraZeneca rose 2.6 percent, or $1.33, to $52.84 in extended New York Stock Exchange composite trading yesterday, after closing 3.2 percent higher before the voting. Each ADR represents one ordinary share.
The FDA is scheduled to decide on Brilinta by Sept. 19. While the agency usually follows the recommendations of its panels, it isn’t required to do so. The advisory panel met yesterday in Adelphi, Maryland.
Brilinta would compete with Bristol-Myers Squibb Co. and Sanofi-Aventis SA’s Plavix and Effient, sold by Eli Lilly & Co. All three are pills designed to prevent platelets in the blood from clumping together to form clots, which can cause heart attacks and strokes.
Plavix, introduced in 1997, had sales of $9.8 billion last year. Effient, approved in July 2009, had $27 million in sales last year for Indianapolis-based Lilly and its marketing partner, Daiichi Sankyo Co. of Tokyo.
Brilinta is under review for use in people with previous heart attacks and chest pain known as acute coronary syndromes.
Results from AstraZeneca’s key company-funded study, called Plato, indicated the drug was generally more effective than Plavix in worldwide testing. At the same, it seemed to be worse for study participants in just the U.S. and Canada. In a report released this week, FDA staff rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome.
Use in U.S.
“Based on how the drug is used in the U.S., it’s not clear it has an advantage, and it may have a disadvantage,” said Jeff Holford, a London-based analyst with Jefferies International, in a telephone interview yesterday. “The commercial application in the U.S., without resolving that issue, is clearly impacted.”
While it’s not unprecedented for a study to show less benefit for U.S. patients and still be used for approval, “the discrepancy was larger than we usually see,” according to Bob Temple, director of the FDA’s Office of Drug Evaluation.
“I’m obviously concerned about it,” said panel chairman Sanjay Kaul, the director of cardiology fellowship training at Cedars-Sinai Medical Center in Los Angeles. “The issue in my mind comes down to whether we require the sponsor to minimize or eliminate the uncertainty pre-approval or post-approval in a manner that the FDA is able to control.”
Plavix and Effient are both taken daily and remain effective for one week after treatment is halted. Twice-a-day Brilinta, known chemically as ticagrelor, wears off more quickly so it may pose a lower risk of bleeding for surgery patients.
“I think it will be a very important advance in medicine” if approved, said David Pearle, a cardiologist and professor at Georgetown University Hospital in Washington, in a telephone interview. “It may be that ticagrelor will be our everyday workhorse with the others being used in certain niches.”
In the Plato study, 18,624 patients got Brilinta or Plavix for a year after being treated for a heart attack or worsening chest pain. With Brilinta, 9.8 percent of patients had a heart attack, stroke or died from cardiovascular disease. That compared with 11.7 percent for those on Plavix, according to data published in August 2009. Death from all causes was 4.5 percent with Brilinta and 5.9 percent with Plavix.
Discussions with FDA
“We look forward to continued discussions with the FDA as it evaluates the panel’s recommendation and completes its review, said Howard Hutchinson, AstraZeneca’s chief medical officer. The company is scheduled to report second-quarter earnings today.
About 733,000 hospitalizations in 2006 were credited to heart attacks and chest pain, representing a “conservative estimate” of the prevalence of acute coronary syndromes, according to the American Heart Association. Cardiovascular disease remains the leading cause of death worldwide.
Lipitor, made by New York-based Pfizer Inc., is the world’s best-selling drug with 2009 revenue of $11.4 billion. GlaxoSmithKline Plc is the biggest U.K. drugmaker and, like AstraZeneca, is based in London.