AstraZeneca's Brilinta Fails to Win FDA Approval


AstraZeneca (AZN) announced that it failed to win the approval of the U.S. Food and Drug Administration for its heart drug Brilinta, a blood-thinner that the company -- facing a severe patent cliff -- has high hopes for. Shares in the U.K. drugmaker dropped in London and were over 5% lower in premarket trading in New York.

The FDA requested additional analyses of data from a large study called Plato that AstraZeneca had conducted. The study showed Brilinta (ticagrelor) worked better than Sanofi-Aventis's (SNY) and Bristol-Myers Squibb's (BMY) popular drug Plavix (clopidogrel) in preventing heart attacks, strokes and deaths from cardiovascular causes in patient with acute coronary syndrome, or heart conditions caused by the blockage of arteries flowing to the heart.

The problem was that American patients had worse results on Brilinta than people from other countries. Plavix was the second-biggest-selling drug in the world in 2009, after Pfizer's (PFE) cholesterol drug Lipitor, with nearly $10 billion in sales. If approved, Brilinta could take a piece of that pie, with analysts estimating sales reaching at least $2 billion within two to four years.

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AstraZeneca says it's evaluating the FDA's request for additional analyses and will respond as soon as possible. The agency did not request additional studies, AstraZeneca said, adding the company "remains confident in the drug application and in its ability to respond to the agency's questions."

"Our highest priority is to provide the requested Plato analyses to the FDA and progress to completion of the Brilinta NDA [new drug application] review," said Martin Mackay, president of research & development.

But investors, who also pinned their hopes on approval of Brilinta, weren't encouraged by the request for additional analyses. That's bound to delay approval of the potential blockbuster, making it more difficult for the pharmaceutical company to offset lost sales as a result of generic competition when several of its main drugs lose patent protection in the next four years. Not only that, the FDA request may also be an indication of possible limitations the agency will put on how Brilinta should be used, hindering projected sales.

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