SkyePharma PLC announced the submission by Novartis Pharma AG of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and to health authorities in EU for Foradil Certihaler (formoterol fumarate inhalation powder). The Certihaler embodies SkyePharma's Skyehaler novel, breath-activated multi-dose dry powder inhaler (MDDPI) technology to ensure patients receive their full, prescribed dose of medication every time. Product stability is greatly improved by Skyeprotect, a powder formulation technology, which protects the drug from moisture.

SkyePharma, who will manufacture and supply the Foradil Certihaler, and Novartis have co-developed this evolution of the Foradil line, aiming to provide a valuable option for asthma patients who require maintenance therapy with a long-acting bronchodilator. The NDA submission by Novartis triggers an undisclosed milestone payment to SkyePharma.

Michael Ashton, SkyePharma's Chief Executive Officer commented "This filing moves SkyePharma closer to its goal when the greater proportion of our earnings will derive from product-related revenues. It also highlights how SkyePharma has transformed its business offering. We are now able to act in true partnership right the way through the development process from product design and formulation to manufacture and supply. The fact that Novartis, a leading player in the pharmaceutical industry, chose to work with SkyePharma on this project validates both our business model and our technical strength in the challenging area of inhaled product development."

In October, Novartis granted Schering-Plough exclusive U.S. distribution and marketing rights to all Foradil products. Schering-Plough currently markets Foradil Aerolizer (formoterol fumarate inhalation powder). Novartis Pharma AG retains international rights to the FORADIL product line.