Drug delay hits AstraZeneca

ASTRAZENECA was today hit by news that its cholesterol-lowering drug Crestor cannot be launched in the key US marketplace until at least the second half of 2003.

The drugs company's shares lost 110p to 2225p, continuing a volatile few weeks for the stock that began with an announcement from the US Food and Drug Administration in June giving Crestor an 'approvable letter' but stopping short of full approval for the drug.

The Anglo-Swedish group sought to reassure investors today by saying it will provide the FDA with extra information by early next year that should satisfy any remaining concerns.

However, the target review time for such information is six months. This means that the earliest possible date for full approval is the third quarter in 2003, and even then the manufacturer has logistical issues to resolve before the drug can be distributed.

An AstraZeneca spokesman said Crestor is still scheduled for launch in Europe by the end of this year: 'We're not changing our guidance for approval in Europe, which is due in the second half of this year,' he said. 'We could see distribution in Europe by the end of 2002.'

He also said FDA concerns over the use of Crestor at a high dosage of 80mg made no difference to the commercial prospects for the drug.

'Our position on the 80mg dosage is that we're not seeking approval for it in the US or Europe at this time although we may revisit it at a later date. We always saw 10mg-40mg as the commercial window and budgeted for that.'