AZ's blockbuster Brilinta runs into FDA roadblock

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Regulators at the FDA handed AstraZeneca ($AZN) a painful setback on its biggest late-stage pipeline prospect this morning. Rather than approve the blood thinner Brilinta, the agency issued a complete response letter demanding a fresh round of data analysis from a late-stage trial. And while the delay may not be severe, analysts immediately started fretting about the potential impact it could have in limiting the drug's blockbuster potential.

The stakes are high. Bloomberg's average peak sale projection from three analysts comes in at $2.7 billion by the year 2015, a revenue stream that AstraZeneca badly needs to make up for the rapidly approaching loss of exclusivity on Nexium. But the FDA rejection quickly triggered some deep qualms about the drug's future. "This delay will come as a disappointment to many and may also start to raise uncertainties about the potential scale of the product's likely commercial success," noted Jeffrey Holford, an analyst at Jefferies International. Analyst Mark Clark at Deutsche Bank also voiced concern that the delay would sap the market's confidence in Brilinta's ability to pump in 10 percent of AstraZeneca's revenue by 2015.

With AstraZeneca's stock sliding five percent on the news, CEO Martin Mackay quickly tried to calm those fears by promising to deal with the agency's questions on Brilinta--or ticagrelor--as quickly as it can. Said Mackay: "Our highest priority is to provide the requested Plato analyses to the FDA."

Brilinta won a lopsided seven to one vote from the agency's expert panel. But they also had a detailed discussion about the data, which demonstrated that Americans and Canadians did less well on Brilinta than patients from other countries. Investigators tried, and failed, to put it off to wider use of aspirin in U.S., but the agency never bought that explanation. Agency advisors were willing to wait until after marketing began for a follow-up study.

- read the AZ release
- and here's Bloomberg's report
- see the Reuters story

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