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UPDATE 2-New AstraZeneca heart drug hits snag in France

Stock MarketsMar 23, 2011 01:17PM ET
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* Company withdraws reimbursement submission, will resubmit

* Brilinta is AstraZeneca's biggest new drug hope

* France accounts for nearly third of EU anti-platelet sales

(Adds analyst comment, latest shares, background)

By Ben Hirschler

LONDON, March 23 (Reuters) - AstraZeneca's new heart medicine Brilinta -- a rival for the world's second-biggest selling drug, Plavix -- faces a snag in winning reimbursement in France after officials there asked for more information.

The Anglo-Swedish drugmaker said on Wednesday it had decided to withdraw the reimbursement submission to the French Transparency Commission (TC) and would resubmit in the coming months.

Brilinta, known as Brilique in Europe, is a pivotal product for AstraZeneca as it seeks to make up for sales of older drugs being lost to generic competition.

Its path to market has been difficult, however, with the U.S. Food and Drug Administration delaying a decision on its approval until July.

In Europe, the drug has been approved in 27 countries but the majority of launches are not due to occur until the second half of the year due to pricing and reimbursement negotiations. It has so far been launched in Germany, Britain and Denmark.

"The company remains confident in its ability to respond to the TC's request for additional information," AstraZeneca spokeswoman Sarah Lindgreen said in a statement.

France is one of the largest potential markets for the new medicine, accounting for nearly a third of anti-platelet drug sales in Europe, and the setback in France will unsettle investors already worried about its U.S. prospects.

Sanford Bernstein analyst Tim Anderson, who first flagged up the issue in a research note, said the French authorities appeared to have ruled that the risk/benefit profile of Brilinta was unfavourable or uncertain, and as such the drug would not be able to advance to final pricing discussions or launch.

Shares in AstraZeneca ended down 0.5 percent at 2,834 pence after a low of 2,811.5p.

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

The blood thinner is a competitor to Sanofi-Aventis and Bristol-Myers Squibb's Plavix, which has sales of more than $9 billion a year.

Brilinta is designed to prevent dangerous blood clots in patients with serious chest pain or previous heart attacks.

As well as competing with Plavix, which is now off patent in parts of Europe and will lose U.S. patent protection in 2012, it is also a rival for Eli Lilly's and Daiichi Sankyo's newer drug Effient.

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

(Editing by Erica Billingham)

UPDATE 2-New AstraZeneca heart drug hits snag in France

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