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Friday, July 23, 2010astrazenecabusiness

AstraZeneca slips ahead of US meeting on its Brilinta heart drug

AstraZeneca is under pressure ahead of a couple of key events next week, with its shares down more than 2%. On Thursday - 29 July - the company is due to report second quarter and half year figures. But the day before comes a meeting of a US Food and Drug Administration advisory panel to discuss its new heart drug Brilinta, and whether or not to grant approval. Some believe that even if the panel gives the drug the go-ahead, there could still be further delays before full approval. Analysts at Jefferies International said: We suspect that the panel of key opinion leaders may vote in favour of approval. [But] we expect the FDA to follow with a subsequent request for more clinical trials to be conducted before an approval for the US market is given. We continue to see Brilinta as carrying a number of commercial handicaps regarding its future sales, i.e. twice daily dosing, higher dyspnoea rates than Plavix or Effient, increased minor bleed rates, potential exclusion populations and significant cost/efficacy hurdles once Plavix generics penetrate its potential markets. We estimate peak sales for Brilinta of $2bn, though with the added caution of a possible delay to US approval against consensus expectations. In the uncertainty ahead of the meeting, Astra's shares have fallen 71p to £31.52.

Source: The Guardian ↗

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