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Last Updated: Monday, 13 September, 2004, 16:24 GMT 17:24 UK
AstraZeneca hit by drug rejection
Pills
AstraZeneca has been working on producing new drugs
Shares in Anglo-Swedish drug giant AstraZeneca have fallen after a US medical panel advised regulators to reject its anti-clotting pill Exanta.

The drug had been seen as a key product for the company's future growth.

A Food and Drug Administration (FDA) panel said Exanta's risk of harming the liver and heart outweighed potential benefits in preventing blood clots.

In London, shares in AstraZeneca slid nearly 4.5% on the FTSE 100 to end the day at 2340 pence.

This news will damage sentiment and forecasts severely
Martin Hall, HSBC

The FDA will now decide on 23 October whether or not to approve Exanta.

The group had been hoping that Exanta and other new drugs would make up for falling sales of ulcer pill Losec-Prilosec.

The drug is the first oral anti-coagulant to be developed in the last half-century.

It was designed to replace warfarin in the prevention of strokes and blood clotting after hip and knee replacements.

Safety trials

Martin Hall, a pharmaceuticals analyst with HSBC, said the panel's decision was the worst possible outcome for AstraZeneca.

"AstraZeneca is likely to withdraw its application to prevent getting a 'not approvable' letter in December and re-submit with new data in two years time," he wrote in a note.

"This news will damage sentiment and forecasts severely."

The panel of outside experts encouraged the FDA to require additional safety trials.

In July AstraZeneca reported that sales in the three months to June were up by 19% to $5.29bn (�2.87bn), with profits up 24% to $1.14bn.


SEE ALSO:
New drugs fuelling AstraZeneca
22 Jul 04  |  Business
AstraZeneca in $355m fraud fine
20 Jun 03  |  Business
Drug giants beat forecasts
30 Apr 03  |  Business


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