SkyePharma has suffered a setback as the UK drug delivery firm revealed that discussions concerning the commercialisation in the USA of its asthma treatment formoterol Certihaler have ended.

The dry-powder inhalation device already has approval from the US Food and Drug Administration but the product’s fate seems to be sealed following a recent recommendation by a joint advisory committees to the agency. Those panellists declared that the benefits did not outweigh the risks in the current asthma indications for long-acting beta agonists such as formoterol when administered alone.

SkyePharma noted that ending of production for formoterol Certihaler will result in asset write-downs and a related non-cash charge of about £7-£8 million. The charge will be taken against the London-headquartered company’s full-year 2008 results.

Chief executive Ken Cunningham said it is “disappointing that formoterol Certihaler is unlikely to be commercialised, but we remain confident of the prospects of our other pipeline products”. In particular, SkyePharma has high hopes for the asthma combination drug Flutiform (fluticasone and formoterol) which remains on track for filing in the USA in the forthcoming first quarter.