AstraZeneca slumps as heart drug hit by new setback - The Independent

Astrazeneca's ambitions for its Brilinta drug have suffered another blow after US regulators held back their approval and asked for additional analysis of clinical trial data, delaying the launch of the pharma group's much anticipated heart medicine.

The company revealed yesterday that the US Food and Drug Administration has made a request for additional information, rather than giving the green light expected by the market. Although Astra said the FDA had not asked for any additional clinical studies, its shares slumped by almost 7 per cent as investors digested the news of the setback.

Brilinta is seen as Astra's answer to Plavix, the world's second best-selling drug. Manufactured by Sanofi-Aventis and Bristol-Myers Squibb, Plavix notched up sales of more than $9.5bn (£6.1bn) last year.

This is the second time the FDA has delayed approval of Astra's drug. The pharma giant applied for clearance in November last year and the initial deadline for approval was set for September. But the date was pushed forward when the regulator said it needed more time to study the application and would only complete its review in December.

The latest delay, which comes just days after European Commission regulators cleared the drug, means that Astra will now have to wait longer – possibly up to another year, according to some analysts – before it gets clearance from US authorities.

However, the company struck a hopeful note, saying it remained "confident" both in its application and in its ability to respond quickly to the US agency's questions.

Brilinta, which will be sold as Brilique in Europe, is seen as the pharma group's key new drug, something which, it is hoped, will help offset patent expiries in coming years. More than half of the group's revenue base for this year is "likely to face loss of patent exclusivity by 2016", according to Goldman Sachs, whose analysts said the delivery of new drugs was "key to AstraZeneca's near to mid-term prospects".

Evolution Securities said the developments highlighted the problem of counting on a limited number of products. "This does emphasise, to us, the risks associated with AstraZeneca – in that if you are dependent upon a small number of products, one 'issue' can have a disproportionate impact on the business," Evolution analyst Dominic Valder said.

Mr Valder added that the "lack of a sustainable core" was the key reason for his bearish view on Astra.

One reason for the market's surprise at the FDA's failure to approve the drug is that Brilinta was strongly endorsed by an independent advisory committee in July.

"To us, if there was any hidden risk, like a safety signal, we would have seen it in July at the [advisory committee] meeting," said Savvas Neophytou, a Panmure Gordon analyst.

At the close, AstraZeneca was the weakest stock on the FTSE 100 Index, ending 6.72 per cent down at 2941p last night.

via independent.co.uk

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