SkyePharma is celebrating after winning German approval for its Foradil Certihaler (formoterol fumarate) in the treatment of asthma and chronic obstructive pulmonary disease.
Foradil Certihaler was co-developed by SkyePharma and Novartis and was filed for regulatory review in Europe on a country-by-country basis beginning in December 2002. it has so far won the green light in Switzerland [[09/03/04e]], Austria, Finland, Portugal and the Netherlands and Germany, as well as five Latin American countries. It has deemed approvable by the US regulator, following its filing in December 2002, and Novartis is preparing to provide the agency with the additional data requested. Novartis licensed the US Foradil franchise to Schering-Plough in 2003 [[11/04/03d]].
Michael Ashton, SkyePharma’s chief executive officer, commented: “We are now manufacturing launch material for our partner and look forward to the initiation of commercial sales.” SkyePharma will earn a royalty on future sales of Foradil Certihaler – a long-acting, multi-dose dry powder inhaler device and powder formulation that protects the drug from moisture – in all markets