A technical error means that SkyePharma faces a delay in making a European filing for its flagship asthma combination drug Flutiform.
The UK drug delivery specialist said that it has been notified by partner Mundipharma that there may be a few months’ delay in the filing of the European Marketing Authorisation Application for Flutiform (fluticasone and formoterol). SkyePharma said that this is due to the need to recruit additional patients into the on-going high- dose strength study.
This is because some patients were assigned to the wrong study arm “due to a randomisation issue”. However, SkyePharma said there is no cost implication for the additional work to the firm as a result of this development.
Analysts do not appear to be worried by the news of the European delay. Jacob Plieth at Edison Investment Research noted that “we take comfort in the fact that there are no safety or cost implications and the company’s assurance that Flutiform remains on track for a New Drug Application filing in the USA in the first quarter of 2009.
