AstraZeneca's Brilinta May Be Cleared By U.S. FDA
AstraZeneca Research and Development Lab
AstraZeneca
Medicine chemistry at AstraZeneca's Research and Development Lab Charnwood, UK.
Medicine chemistry at AstraZeneca's Research and Development Lab Charnwood, UK. Source: AstraZeneca
AstraZeneca Plc gained in London trading after U.S. regulatory staff said the blood-thinner Brilinta is approvable if the drugmaker undertakes a study on its effectiveness in Americans once it’s marketed.
The shares rose 63 pence, or 2 percent, to close at 3,189 pence at 4:30 p.m. That gives the U.K.’s second-largest drugmaker a market value of 45.9 billion pounds ($71.4 billion).
AstraZeneca needs to replenish revenue over the next four years as patents expire on top-sellers Nexium for heartburn and the antipsychotic Seroquel, medicines that generated a combined $9.83 billion in 2009. The new study, recommended yesterday by U.S. Food and Drug Administration advisers, would seek to establish the treatment’s long-term benefit after results from testing in North America fell short of those seen elsewhere. Brilinta sales could reach $1.47 billion by 2016, according to the average estimate of three analysts surveyed by Bloomberg.
“The documents read more favorably in support of approval than we had expected, including around the key issue of U.S. patients,” Brian Bourdot, a Barclays Capital analyst in London, said in a report to investors today.
The drug would compete with Bristol-Myers Squibb Co. and Sanofi-Aventis SA’s Plavix, the world’s second-biggest drug, 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.
Panel Meeting
FDA advisers meet tomorrow to weigh whether to support Brilinta’s approval and the regulator is scheduled to decide by Sept. 19. The agency usually follows the recommendations of its advisory committees, though it isn’t required to do so.
If approved, Brilinta will “take substantial market share” because of its superior efficacy and health-care economics compared with Plavix, Bourdot said. That could push Brilinta’s yearly sales to more than $4 billion after the U.S. patent on Plavix expires in 2011, he said.
Results from AstraZeneca’s key company-funded study called Plato indicated that Brilinta, while generally more effective than Plavix, seemed to be worse than the other drug for study participants in the U.S. and Canada. AstraZeneca has suggested that higher aspirin use in the U.S., compared with other regions where Brilinta was tested, may have contributed to the unexpected outcome.
Delayed Onset
FDA reviewers examined this issue and determined that the timing of dosing in the U.S. and a potential delayed onset of Brilinta, which is also known as ticagrelor, may explain the discrepancy better than use of aspirin.
“The Office of Clinical Pharmacology has reviewed the submission and cannot resolve the differential effectiveness of ticagrelor in U.S. and non-U.S. sites,” FDA staff said in their report. “Given the overall results, the Office recommends approval of ticagrelor with a study post-approval aimed to reconcile the findings from the U.S. region.”
In Plato, 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.
Bleeding Risk
Life-threatening bleeding occurred in 11.6 percent of Brilinta patients and 11.2 percent on Plavix, though the difference wasn’t statistically significant.
Plavix and Effient are both taken daily and remain effective for one week after treatment is halted. Brilinta, taken twice daily, wears off more quickly. All three pills increase bleeding risk with surgery.
“In all these drugs there’s a tradeoff in effectiveness and bleeding,” said David Pearle, a cardiologist at Georgetown University Hospital in Washington, D.C., in a July 21 telephone interview. “Brilinta it turns out may be a little bit closer to the sweet spot than either Plavix or Effient. In other words, we want just enough platelet blockage to be effective but no more bleeding than is absolutely necessary.”
The Plato trial also pitted Brilinta primarily against a 300-milligram dose of Plavix, half the standard dose used in the U.S. since 2007, said Amit Roy, an analyst with Nomura International Plc in London, in a July 15 research report.
No Major Impact
“We do not expect a major impact of Brilinta on current medical practice,” Roy said. Brilinta may struggle to gain market share, as occurred with Effient, also tested against a 300-milligram Plavix dose, Roy said.
Plavix, chemically known as clopidogrel, had $9.8 billion in sales last year for New York-based Bristol-Myers and its marketing partner, Sanofi of Paris. Effient, approved in July 2009, had sales of $27 million last year for Lilly, based in Indianapolis, and its marketing partner Daiichi Sankyo Co. of Tokyo. The pill, also called prasugrel, was cleared with a warning of bleeding risk.
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.
To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net. Trista Kelley in London at Tkelley2@bloomberg.net
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