Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
90TEN

90TEN is an award-winning healthcare communications consultancy that puts people at the heart of everything we do. Our Life.Changing. campaigns...

Latest intelligence

From lay summaries to patient engagement programmes: how patient-centricity is finally becoming a reality
How pharma is progressing their commitment in patient engagement...
Cuttsy+Cuttsy awarded CPD Platinum by the IPA
Four years after being awarded Gold for their continuous professional development (CPD) Cuttsy+Cuttsy (C+C) have reached another milestone and been awarded Platinum accreditation....
Breaking Bad
Six behaviours separate the good brand teams from the bad...

Infographics