Astra shares dealt regulatory blow

Shares in pharmaceuticals giant AstraZeneca tumbled on Friday after approval for a new heart drug was delayed by a US regulator’s demand for more information.

The Food and Drug Administration (FDA) wants further analysis of research into Brilinta – a blood-thinning pill – before it clears the drug for sale in the US.

The move could set AstraZeneca’s US plans back by nine months, one analyst said. Shares fell more than 6%.

The group, which employs 11,000 staff in the UK, won marketing approval in Europe earlier this month for Brilinta and a similar vote was expected from the FDA, but the regulator now wants more details from a recent study on the drug.

Astra has shifted focus on to new drugs like Brilinta in the wake of increased competition from cheaper rivals against its core range.

Brilinta, like the market’s leading anti-clotting drug Plavix, is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes. The company recently conducted the study into Brilinta on nearly 20,000 patients who had been treated for a heart attack or worsening chest pain in 43 countries. Astra’s submission to the US was based on the results of this trial programme.

Astra said it remained confident the FDA will not require additional clinical trials – which would be costly for the company – and plans to provide the additional analysis as soon as possible.

Tom Kemp, analyst at Panmure Gordon, said the FDA’s move was “not good” for Astra and expects a nine-month delay. Mr Kemp said Astra’s trial had proven the drug could stand up to rival Plavix, produced by French firm Sanofi-Aventis. But he added: “We believe the company has been negotiating strongly on the label and probably pushed it too far so the FDA responded with a request of further analysis.”

Astra’s UK sites include Macclesfield and Wilmslow in Cheshire, Luton, Loughborough, Edinburgh and Brixham in Devon.

AstraZeneca recently posted a 26% drop in pre-tax profits in its third quarter to 2.2 billion US dollars (£1.4 billion), blaming a mixture of legal costs and increased competition from cheaper rivals.