AstraZeneca, the Anglo-Swedish pharmaceuticals group, yesterday suffered another setback when it suspended the marketing of Irissa, a lung cancer drug launched early this year.
The company said it was in discussions with regulators over the possibility of withdrawing Irissa after the preliminary findings of a clinical trial showed that it had failed to significantly prolong the life of patients.
In a sign of the need for a broader overhaul of its operations, AstraZeneca also replaced Mr Martin Nicklasson with Dr John Patterson as executive director for development, with a remit to improve the company's relations with regulators and its approach to risk management.
Irissa is AstraZeneca's fourth high-profile medicine to face problems in the past three months. In September, the company failed to gain US regulatory approval for Exanta, a blood-thinning drug. The company also revealed slippage in its development of Galida, a diabetes drug.
In October, a US Food and Drugs Administration official indicated that Crestor, an anti-cholesterol drug, was under review, though the agency has since downplayed his remarks.
AstraZeneca's share price fell more than 8 per cent yesterday, closing down 170p at £18.86 (€27.49). Sir Tom McKillop, AstraZeneca chairman, yesterday described the news on Irissa as "disappointing".
"This has been a difficult and challenging year for the company," he said, adding it remained "financially very strong".
Mr Duncan Moore, analyst with Morgan Stanley Europe, said: "This represents another big pipeline opportunity for AstraZeneca gone, and a much bigger opportunity for OSI [the manufacturer of the rival lung cancer drug Tarceva]." OSI's shares were up more than 43 per cent at $67.39 in early Nasdaq trading.
AstraZeneca only received approval for Irissa from the FDA at the start of this year, conditional on further studies, but it had been licensed in more than 30 countries.
AstraZeneca said sales of Irissa for the first nine months of the year were $300 million, half from the US and one-third from Japan. The company said it was not changing its earnings guidance of $2.10 a share for 2004, and that the maximum provisions it would be likely to take would be the $70 million of outstanding stock.
The Irissa clinical study did demonstrate some scope for more restricted future use of the drug, which prolonged life in Japanese patients and non-smokers.
