AstraZeneca shares hit by cholesterol drug delay

Astrazeneca conceded yesterday that it will need to do additional safety trials on its new cholesterol-busting drug Crestor before launching the product on the US market.

The news means Crestor will not reach patients in the world's most lucrative pharmaceuticals market for another year, and could mean AstraZeneca fails to hit the market's profit forecasts for 2003. The company's shares, which have lost a third of their value in three months, ended down 4 per cent at 2,248p yesterday, after earlier falling as much as 8 per cent.

Although the Food and Drug Administration has said it could approve Crestor for launch with certain conditions, after a meeting earlier this week it became clear AstraZeneca would need to do more trials to convince the US medicines regulator to allow the drug on the market in doses that would make the product commercially viable. Safety concerns have dogged Crestor's development since last year, when a similar drug ­ Bayer's Baycol ­ was withdrawn after being linked with 100 deaths. Side effects of the class of drug known as statins include a potentially fatal muscle-wasting disorder.

AstraZeneca said yesterday it had pulled its application to launch a super-strong dose of Crestor in both the US and Europe. In a short statement, the company said: "AstraZeneca has undertaken to provide further information from its ongoing study programme to supplement that already submitted.... There are now more than 10,000 patients in ongoing studies of Crestor and the company remains confident in the product's profile and commercial potential."