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SkyePharma shares fall as FDA queries asthma drug

SkyePharma's shares fell approximately 10 per cent as it warns of potential delays to the US launch of its flagship asthma treatment, Flutiform.

SkyePharma's shares fell approximately 10 per cent as it warned of potential delays to the US launch of its flagship asthma treatment, Flutiform.

The FDA, said the UK-based drug delivery firm, had questioned one particular aspect of the design of the phase III clinical trial programme.

SkyePharma revealed that the FDA query may force the company to conduct more clinical data to supplement the ongoing programme to satisfy the FDA and possibly delay the NDA until H2 2008.

Analysts had expected Skye Pharma to file for approval by Q4 2007 or Q1 2008, with a launch in Q2/ 3 2009.

Last week, GlaxoSmithKline's migraine drug, Trexima, was also held up by the FDA, after receiving only an approvable letter that asked the UK drug company for more safety data be before final approval was given.

CEO of SkyePharma, Frank Condella, refused to comment on what part of the clinical trial design the FDA had identified, but stressed that it was not a safety issue. He added that the programme had been positively reviewed by the FDA late 2005.

Shares in SkyePharma dropped 9.3 per cent to GBP 19.50 in am trading on 6 August.

6th August 2007

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