Formoterol dry-powder inhalation - Novartis/SkyePharma: Foradil MDDPI, Foradil MDPI, Foradil SkyeHaler, formoterol fumarate dry-powder inhalation

In November 1998, Novartis Pharma of Switzerland and SkyePharma PLC of the UK signed an agreement to jointly develop a new formulation of the β2-adrenoceptor agonist formoterol (Foradil®). The new product, Foradil® Certihaler™, utilises a multidose dry-powder inhaler (MDPI or MDDPI) device, SkyeHaler™, developed by SkyePharma. It also utilises SkyePharma's SkyeProtect™ powder formulation technology, which protects the drug from moisture. The product is waiting for approval for the treatment of asthma. Foradil® MDPI may also have potential for the treatment of chronic obstructive pulmonary disease (COPD). Novartis has stated that Foradil® Certihaler™ offers certainty of dosing and dose confirmation, and will also contain a dose counter that indicates the number of doses left. SkyePharma is responsible for development of the product in its finished form; this includes the supply of both the powder and the inhalation device as a product to Novartis. The product is manufactured at SkyePharma's Lyon facility in France. SkyePharma is receiving fees, development costs and milestone payments from Novartis. SkyePharma will also receive royalty income on worldwide sales. SkyePharma has granted Novartis an exclusive worldwide licence to market Foradil® MDPI. Foradil® Certihaler™ was approved in Switzerland in March 2004. This is the first approval in Europe, and will trigger an undisclosed milestone payment by Novartis to SkyePharma. Submissions for regulatory approval in the asthma indication were filed in the EU (on a country-by-country basis) and the US in December 2002. On 22 October 2003, SkyePharma announced that the US FDA had issued an 'approvable' letter for Foradil® Certihaler™. Launch of the product is anticipated for 2004. Clinical trials of Foradil® MDPI for the treatment of asthma began in October 1999. In December 2000, phase III trials commenced in Europe. SkyePharma stated in April 2001 that phase III trials had commenced recently in the US. SkyePharma estimated in April 2001 that the worldwide sales potential of Foradil® MDPI could be as much as $US600 million. SkyePharma anticipates receiving royalties and manufacturing revenues of more than 10%. © 20O4 Adis Data Information BV. All rights reserved.