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UPDATE 1-SkyePharma says more tests needed for asthma drug
September 1, 2009 / 7:47 AM / 8 years ago

UPDATE 1-SkyePharma says more tests needed for asthma drug

* More clinical data needed by U.S. authorities

* Says U.S. approval of Flutiform ‘unlikely’ before H2 2011

* Partner Abbott will pay for tests and can recoup costs

* Shares fall almost 4 percent

(Adds details)

LONDON, Sept 1 (Reuters) - British drug delivery company SkyePharma SKP.L said on Tuesday it will need to do more tests on its asthma drug Flutiform, pushing the expected U.S. approval out to late 2011 and sending its shares down almost 4 percent.

The company has been told by the U.S. Food and Drug Administration that further tests will be required to get more data on the effects of different doses.

At 0731 GMT shares in the company were down almost 4 percent to nearly 107 pence per share.

Under the current license agreement, the company’s development partner Abbott (ABT.N) is responsible for paying for additional U.S. clinical trials, and is entitled to recoup its costs from future milestones and royalties.

Reporting by Ben Deighton; Editing by Clara Ferreira-Marques

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