Pharmaceutical company SkyePharma saw its share price drop in early trading today after the London-based company revealed that clinical trials for its new asthma treatment had been queried by the US drugs regulator.
Its application to seek clearance for the flagship drug Flutiform from the US Food and Drug Administration (FDA) is subsequently expected to be set back until the second half of 2008, the company confirmed in a statement.
SkyePharma said that the delay was likely to cost them between £3 million and £5 million.
However it stressed that the additional clinical work it intended to make in order to satisfy the US drugs regulator was not expected to impact upon timescales or costs for the development of Flutiform for the European drugs market.
The company explained that the FDA had "unexpectedly" queried a particular aspect of its clinical trial programme for the drug.
Having considered the issue SkyePharma said it had concluded that it might be necessary to provide additional clinical data in order to supplement its current trial programme.
But the company insisted that it had "increased confidence" in the process for developing of Flutiform.
"Although the potential requirement for additional clinical data would mean that we face some delay to the filing of Flutiform, we are pleased with the progress being made with the FDA on all other aspects of the planned filing and we are encouraged by the level of commitment of Abbott Laboratories, our US partner, to the project," said SkyePharma chief executive Frank Condella.
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