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
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)
- Judge rejects strict limits on U.S. nurse who treated Ebola patients |
- Test flight of Virgin Galactic spaceship ends in fatal crash in California
- Suspect in Pennsylvania police ambush denied bail |
- Dow, S&P 500 end at record highs; BoJ move adds fuel to rally |
- Judge issues order enforcing Ebola isolation of defiant Maine nurse