The German pharmaceutical regulatory authority has approved Foradil Certihaler (formoterol fumarate inhalation powder) of SkyePharma for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Foradil Certihaler was co-developed by SkyePharma PLC and Novartis Pharma AG. Foradil Certihaler is a trademark of Novartis. Foradil Certihaler was submitted for regulatory review in Europe on a country-by-country basis beginning in December 2002 and has now been approved in Switzerland, Austria, Finland, Portugal and the Netherlands as well as in Germany. It has also been approved in five countries in Latin America.

Foradil Certihaler was also submitted for regulatory review in the US in December 2002. The US Food and Drug Administration (FDA) has assessed the product as approvable and Novartis is preparing to provide the agency with additional data that were requested. The US Foradilâ franchise has been licensed by Novartis to Schering-Plough Corporation.

Michael Ashton, SkyePharma's Chief Executive Officer, commented: "The sixth European approval for Foradil Certihaler is a further milestone in the validation of our pulmonary delivery technologies - already recognised by other unrelated collaborations in the pulmonary area with major pharmaceutical companies such as AstraZeneca and GlaxoSmithKline. We are now manufacturing launch material for our partner and look forward to the initiation of commercial sales."

Foradil Certihaler embodies two proprietary SkyePharma technologies, the Skyehaler, a novel breath-actuated multi-dose dry powder inhaler (MDDPI) device, and Skyeprotect, a powder formulation that protects the drug from atmospheric moisture to ensure product stability and dose-to-dose reproducibility.