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Watchdog delays UK debut of Astra swine flu treatment
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30 July 2009
FluMist, the spraying mechanism that is used to administer its flu vaccine, is available in the US but is still awaiting approval by the drug watchdog in Brussels, which will keep it out of the UK until at least next year.
FluMist works as a nasal spray rather than by injection, meaning needle phobics will prefer it to the jab pioneered by arch rival GlaxoSmithKline. The NHS has bought 60 million doses of the Glaxo vaccine to deal with the pandemic.
The American watchdog the Food & Drug Administration (FDA) approved the seasonal flu version of FluMist over a year ago, helping Astra to rake in $151 million (£92 million) from US sales of its swine flu vaccine so far this year.
But even though Astra submitted FluMist to the European Medicines Agency for approval in January, it is still awaiting a response.
Production has also been hit with delays: although Astra can make 200 million doses of vaccine, it only has 40 million sprayers available. Most of those have already been sold in the US.
The firm has begun clinical studies to find out whether the treatment is as effective via a drop in the nose.
Astra's swine flu vaccine contributed to an 18% rise in second-quarter pre-tax profits, which hit $2.6 billion. The Anglo-Swedish drug giant raised its full-year earnings forecast, after second-quarter sales of its blockbuster cholesterol fighter Crestor soared by a third, topping $1 billion for the first time.
There was also higher demand for the firm's blood pressure drug Toprol XL and cancer treatment Casodex, due to a lack of generic rivals on the market. A push to sell medicines in emerging markets also looks to be paying off: sales rose 8% in the second quarter.
Astra has had a barren drug pipeline since 2003, but submitted three new medicines for regulatory approval in the last three months.
Shares in AstraZeneca soared 57p to 2859½ as analysts digested the figures.
Chief executive David Brennan said: "Our performance in tough economic conditions has been better than anticipated, and continued progress on the pipeline is evidenced by signficant regulatory submissions since our first-quarter report."
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