Kidney drug setback for Shire

SHIRE Pharmaceuticals faced a major setback today as US regulators delayed the approval of its new drug to treat severe kidney disease.

The US Food and Drug Drug Administration has extended by 90 days the date it can give approval for Fosrenol.

Analysts expect the drug to achieve annual sales of up to $200m (£107m) by 2008.

Shire had expected the approval date to be 26 July. But the company's chief executive Matthew Emmens insisted today that the delay would not change the previously-announced US launch date for December this year.

Emmens said: 'In the FDA's letter there were no issues raised about clinical safety or efficacy. We are proceeding with all pre-launch activities including manufacturing, market preparation and salesforce readiness.'

Shire bought the rights to Fosrenol in March for $31m for all countries except Japan and already has approval for the drug from Swedish regulators.

The drug was filed for European approval three years ago but it was delayed over long-term safety fears.

Shire shares were 11p to 447p at midday.