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Analyst: FDA Decision Poses Risk for AstraZeneca

From Associated Press (December 9, 2010)

INDIANAPOLIS -- An upcoming U.S. regulatory decision on AstraZeneca’s blood thinner drug carries substantial risk for the British drug maker that may be underestimated, according to a Jefferies International Ltd. analyst.

THE OPINION: The Food and Drug Administration is expected to complete its review of Brilinta by Dec. 16, and analyst Jeffrey Holford said in a research note he sees a high risk of a delay in the regulatory body’s decision or an "uncommercial labeling" for the drug.

In September, an FDA advisory committee voted 7 to 1 to recommend the approval of Brilinta in patients with acute coronary syndrome, or blocked arteries. An international study conducted by AstraZeneca showed that patients taking Brilinta versus Plavix were less likely to experience various heart-related problems. But U.S. patients studied were more likely to report heart problems while taking the drug.

The drug has received European approval, but that should not reassure investors, Holford said. He noted that the FDA will be focused on the U.S. population, and committee members have said more studies in the United States are needed to confirm the drug’s effectiveness.

"We see a number of significant issues that we do not believe the FDA has enough comfort on to issue a strong label for the product, if at all," Holford wrote, adding that he believes his firm is "anti-consensus" on the approvability of a strong label.

Holford also noted that AstraZeneca faces substantial exposure to generic competition over the next six years.

THE STOCK: Down 42 cents to $47.71 in Thursday morning trading, while broader trading indexes were up slightly.


Posted: December 2010