UPDATE 2-AstraZeneca heart drug wins European green light

Published 09/24/2010, 10:22 AM
Updated 09/24/2010, 10:24 AM

* EMA recommends Brilinta, to be sold as Brilique in Europe

* Brilinta is AstraZeneca's biggest new drug hope

* Consensus forecasts point to sales of $2 bln by 2014

* EU green light was expected, shares up 0.6 percent

* U.S. regulators to decide on drug by Dec. 16

(Updates share price, adds background)

By Ben Hirschler

LONDON, Sept 24 (Reuters) - AstraZeneca's new heart medicine Brilinta won a green light from regulators on Europe on Friday, boosting prospects for its biggest drug hope which analysts expect to become a multi-billion-dollar a year seller.

The European Medicines Agency said it had recommended approval for the drug, to be sold as Brilique in Europe, for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.

Recommendations from the regulator are normally endorsed by the European Commission within a few months.

AstraZeneca is relying on revenues from Brilinta to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.

Industry analysts expect Brilinta's sales to reach $1.95 billion by 2014, according to consensus estimates compiled by Thomson Reuters.

The drug is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's top-seller Plavix, the world's second-biggest drug with sales last year of more than $9.5 billion, which is off patent in parts of Europe and will lose U.S. patent protection in 2012.

Brilinta proved superior to Plavix in a key clinical trial presented last year.

AstraZeneca's product is also a rival for Eli Lilly and Daiichi Sankyo recently introduced Effient, which has so far had slow sales, due to concerns about bleeding risks.

Plavix, Brilinta and Effient all work by stopping blood platelets from sticking together and forming clots that can cause heart attacks and strokes.

Brilinta's approval in Europe had been widely expected by both investors and doctors. In a notable vote of confidence the European Society of Cardiology last month added Brilinta as a treatment option under new European medical guidelines, even though it has yet to be approved for sale.

AstraZeneca shares were 0.6 percent higher by 1400 GMT, outperforming a flat European drugs sector.

In the United States, the product was endorsed by an advisory panel in July, despite a perplexing lack of benefit seen in a North American sub-group of patients in the main clinical trial that showed strong overall advantages.

The U.S. Food and Drug Administration said on Sept. 15 it needed more time to study the application and would now complete its review of Brilinta by Dec. 16 rather than by Sept. 16 as originally indicated. (Editing by Kate Kelland, Greg Mahlich)

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