LONDON (Reuters) - AstraZeneca AZN.L has discontinued development of its experimental drug motavizumab for preventing serious lung disease in infants and will take a charge of $445 million (286 million pounds).
The news is a further setback for the drugmaker’s pipeline but the company said on Tuesday that the charge, to be taken in the fourth quarter, would be excluded from “core” earnings and so had no impact on its guidance for 2010 earnings.
Last week, AstraZeneca’s heart medicine Brilinta failed to win approval from U.S. regulators, delaying a vital new product designed to rival Plavix, the world’s second-biggest selling drug. Brilinta is already approved in Europe.
Motavizumab, too, has faced roadblocks from the U.S. Food and Drug Administration, which issued a second so-called complete response letter for the drug in August, delaying its path to market.
Motavizumab, however, was never viewed as a multibillion-dollar seller on the same scale as Brilinta.
A U.S. medical advisory panel last June cited concerns about potentially serious side effects with motavizumab and said there was a need for more data.
The drug was developed by AstraZeneca’s MedImmune unit to prevent serious respiratory syncytial virus (RSV), which affects around 125,000 infants in the United States each year.
But FDA advisers said they were concerned that data showed the new drug to be only as effective in reducing RSV hospitalisations as AstraZeneca’s current therapy Synagis, while it carried a greater chance of serious skin reactions. Synagis had worldwide sales of $1.1 billion in 2009.
Preventing RSV was the primary use for which motavizumab was being developed. Despite the setback, AstraZeneca said it would continue to explore the use of the monoclonal antibody medicine for other RSV treatment.
Editing by Hans Peters
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