SkyePharma PLC announced that the US Food and Drug Administration (FDA) has issued an "approvable" letter for Foradil Certihaler (formoterol fumarate inhalation powder). This means that the product can be approved by the FDA subject to resolution of certain outstanding issues. The Foradil Certihaler was co-developed by SkyePharma PLC and Novartis Pharma AG. The Foradil Certihaler was submitted for regulatory review in the US in December 2002. Foradil Certihaler embodies two proprietary SkyePharma technologies, the Skyehaler, a novel breath-activated 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.

Formoterol, the active ingredient in Foradil Certihaler, is a long-acting beta-agonist bronchodilator, that combines a rapid onset of action (within1-3 minutes) with a long-lasting bronchodilation of 12 hours. This feature offers large benefits for all patients who suffer from obstructive lung diseases. Formoterol is licensed by Novartis Pharma AG from Yamanouchi Pharmaceuticals. The Certihaler dry-powder inhaler contains 60 doses giving patients the convenience of 30 days of therapy in a single inhaler. This evolution of the Foradil line was developed to provide a valuable and convenient option for asthma patients who require maintenance therapy with a long-acting bronchodilator.

Michael Ashton, SkyePharma's Chief Executive Officer commented, "We are delighted by the FDA's positive reaction to the Foradil Certihaler submission. Royalty income following ultimate approval of Foradil Certihaler will be a key part of moving SkyePharma closer to its goal when the greater proportion of our earnings will be derived from product-related revenues."

In October 2002, Schering-Plough obtained exclusive U.S. distribution and marketing rights to all Foradil products from Novartis Pharma AG. Schering-Plough currently markets Foradil Aerolizer (formoterol fumarate inhalation powder), a single-dose inhalation device. Novartis Pharma AG retains international rights to the Foradil product line. Approval of Foradil Certihaler will trigger an undisclosed milestone payment by Novartis to SkyePharma, which will also earn a royalty on all future Foradil Certihaler sales. SkyePharma will also manufacture and supply Foradil Certihaler.