SkyePharma filing Flutiform in Europe
pharmafile | March 26, 2010 | News story | Sales and Marketing | Fluctiform, Skyepharma
SkyePharma is filing its asthma inhaler Flutiform with European regulatory authorities for approval.
If approved Flutiform, a fluticasone and formoterol combination with a newly patented inhaler, will compete with GlaxoSmithKline’s Seretide, a dual-therapy combination inhaler of fluticasone and salmeterol.
The situation is less positive in the US, where authorities raised a number of issues with the drug in January this year.
This triggered the return to SkyePharma of the product’s New Drug Application from Abbott, which has US marketing rights to Fluctiform.
SkyePharma has requested a meeting with the FDA to determine the steps it needs to take to get the application back on track but has yet to hear form the regulator.
Full year results
Meanwhile, the company last year saw a 10% drop in revenue to £56 million amid lower milestone payments and non-recurring manufacturing costs, but did manage to slash losses from £28.7m to £1.4m.
The year also saw Lodotra launch in Germany for the treatment of rheumatoid arthritis joint stiffness, bringing SkyePharma’s total number of marketed products to 12.
In pipeline developments, SkyePharma’s partner Somnus secured funding for phase II studies of SKP-1041 in sleep maintenance and formulation work for diabetes pipeline candidate SKP-1052 began.
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