AstraZeneca drug launch faces delay

By Stephen Foley
Wednesday 19 March 2014 03:57
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Astrazeneca faces the prospect of delays to the launch of Crestor, its crucial new anti-cholesterol drug, after a rival product was withdrawn from sale following reports of serious side effects.

Bayer, the German chemicals conglomerate, pulled its Baycol cholesterol product yesterday, saying it was linked to potentially fatal muscle weakness in some patients, particularly those who were also using gemfibrozil, a treatment against heart disease.

Baycol is the latest cholesterol-lowering drug from a class known as statins, which also includes AstraZeneca's Crestor.

Analysts said Bayer's move could prompt regulators to demand more safety checks before approving Crestor.

An AstraZeneca spokesman said he remained confident about Crestor's safety profile. "Phase II and phase III clinical trials have involved 4,200 patients and this data has been part of our regulatory filings in the US and Europe."

The US Food and Drug Administration has become increasingly concerned with safety issues in its drug licensing process, attracting criticism from pharmaceutical companies over longer approval times. The UK company hopes to launch Crestor in autumn 2002, and analysts expect sales could reach £3.5bn a year, filling the hole left when its lead drug, the ulcer treatment Losec, loses its patent protection.

Baycol, launched in 1998, was expected to account for a fifth of Bayer's sales and profits this year, and the company issued a profit warning alongside its withdrawal.

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