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AstraZeneca Rises After FDA Approval of Brilinta Heart Drug

AstraZeneca Plc, the U.K.’s second-biggest drugmaker, rose the most more than two months in London trading after winning U.S. approval to sell the blood-thinner Brilinta, a rival to the world’s second-best selling drug.

AstraZeneca advanced 59.5 pence, or 2 percent, to 3,092 pence at the close of trading, where the company is based. The gain was the biggest since May 3.

The Food and Drug Administration cleared Brilinta, which will compete with top-selling blood thinner Plavix, for use by patients with severe chest pain or heart attack history to cut the risk of heart attacks, strokes and death, the agency said yesterday in a statement. Brilinta’s label must include a boxed warning, the agency’s strictest caution, about a risk of bleeding and a reduction in the drug’s effectiveness if taken with more than 100 milligrams of aspirin a day.

“It will be very difficult for U.S. insurance companies to deny coverage of Brilinta” because Brilinta was shown to be more effective than Plavix in the company’s Plato study, Justin Smith, an analyst with MF Global UK Ltd. in London, said in a note to investors today.

The FDA delayed a decision in December, asking for more analysis of the Plato study comparing Brilinta, also known as ticagrelor, with Plavix, made by New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi.

AstraZeneca needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $10.3 billion in revenue last year. Brilinta sales may reach $1.14 billion by 2014, according to the average estimate of seven analysts surveyed by Bloomberg

European Approval

Brilinta won approval from the European Union in December under the name Brilique.

Jeffrey Holford, an analyst with Jefferies International Ltd., wrote in a note today that he has reduced his peak sales estimate for the drug to $1 billion from $2 billion, citing the warning on the label and the introduction of generic Plavix in the U.S. during the second quarter of next year.

Tim Anderson, an analyst with Sanford C. Bernstein & Co. in New York, said he has a “more modest” sales estimate of $750 million in 2015 due to the introduction of generic Plavix.

“We think the biggest impediment to Brilinta’s uptake will be the availability of generic Plavix, which will be available at a fraction of the price of Brilinta,” Anderson wrote in a note to investors last night.

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