* Panel votes 7-1 to urge approval of Brilinta
* Potential $1 bln-plus pill seen as key for company
* FDA usually follows panel recommendations
* AstraZeneca shares add to gains in after-hours trade
(Adds further analyst comment, AstraZeneca official; updates
By Lisa Richwine
ADELPHI, Md., July 28 U.S. advisers backed a
potential blockbuster blood thinner from AstraZeneca (AZN.L)
(AZN.N) on Wednesday, a victory for a company seeking new drugs
to offset expiring patents on some of its best-selling
Members of a Food and Drug Administration panel voted 7-1
to recommend approval of Brilinta for patients suffering from
heart attacks or chest pain who need drug therapy or an
Analysts predict Brilinta's sales will top $1 billion a
year based on strong results showing the medicine reduced
deaths and heart attacks. [ID:nN27103952]
AstraZeneca shares, which surged in the final hour of
regular trading to finish 3.2 percent higher on the New York
Stock Exchange, gained another 2.6 percent in after-hours trade
to $52.84, following the panel vote.
The company overcame doubts about Brilinta's effectiveness
in U.S. patients. In a clinical trial of 18,000 patients, the
relatively small group from North America saw no benefit.
Panel members struggled to explain that result but voted
7-1 that the sharp reduction in deaths and heart attacks in
other patients justified Brilinta's use in the United States.
"The overall results are so striking," said panelist James
Neaton, a statistician at the University of Minnesota.
Viren Mehta, an analyst with Mehta Partners in New York,
said the lopsided vote in favor of Brilinta will prompt him to
review his earlier "conservative" sales projections for the
"Brilinta has potential to be a big product," he said,
especially as new uses of the drug are approved.
The FDA is supposed to make a final decision on Brilinta by
Sept. 16. The agency usually follows panel recommendations.
Anglo-Swedish drugmaker AstraZeneca is counting on
Brilinta, known generically as ticagrelor, to help offset the
looming loss of patent protection on drugs such as heartburn
treatment Nexium and antipsychotic Seroquel.
Consensus 2014 sales forecasts for Brilinta stand at $1.1
billion, according to Thomson Reuters data. The company's total
sales topped $32 billion in 2009.
The panel decision "came out more positive than we
certainly anticipated," Leerink Swann analyst Seamus Fernandez
AstraZeneca now could win approval for treating a broad
range of patients with acute coronary syndromes, which includes
heart attacks and chest pain, he said.
Fernandez said the final FDA ruling could slip beyond the
September deadline, "... but I think we're going to see this
drug on the market in the U.S. and Europe in 2011."
Brilinta would compete directly with Plavix, the standard
anti-clotting drug now given to prevent heart attacks. Sold by
Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb (BMY.N),
Plavix is world's second-best selling drug with annual sales of
about $9 billion.
In AstraZeneca's study, Brilinta proved better than Plavix
in preventing heart-related problems linked to blood clots.
After one year, 9.8 percent of Brilinta patients had suffered a
heart attack, stroke or cardiovascular-related death, compared
with 11.7 percent in the Plavix group.
Brilinta did not increase the chances of major bleeding, a
serious risk of anti-clotting drugs.
But the AstraZeneca drug did not help the roughly 9 percent
of patients who were from North America.
The company argued that higher aspirin doses routinely
given in the United States might have interacted with Brilinta
and a lower aspirin dose could have yielded benefits similar to
those seen in other countries.
FDA reviewers questioned that theory, and panel members
said they could not find an explanation.
"There is great uncertainty about this issue," said Dr.
Sanjay Kaul, the panel's chairman and a cardiologist at Cedars
Sinai Medical Center in Lost Angeles.
Some panelists urged a post-approval study of the drug's
effects in U.S. patients.
Plavix and Brilinta work by stopping blood platelets from
sticking together and forming clots that can cause heart
attacks and strokes.
AstraZeneca said it was pleased with the panel votes.
"We look forward to working with the FDA" as it continues
to review the drug, AstraZeneca Chief Medical Officer Howard
Hutchinson told reporters.
(Reporting by Lisa Richwine; Additional reporting by Ransdell
Pierson and Bill Berkrot in New York; Editing by Robert
MacMillan and Tim Dobbyn)