Press Release: Skyepharma Announces FDA Approves Foradil Certihaler
Skyepharma Announces FDA Approves Foradil Certihaler London, UK -- Dec 18, 2006 -- LONDON, UK, 18 December 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces today that the US Food and Drug Administration (FDA) has approved FORADILÂ® CERTIHALER(TM) (formoterol fumarate inhalation powder) for the treatment of asthma. FORADILÂ® CERTIHALER(TM) has been co-developed by SkyePharma and Novartis, and is a trademark of Novartis. The FDA issued an "approvable" letter for FORADILÂ® CERTIHALER in April 2006. Following a recall from the German and Swiss markets in January 2006 because of concerns that accidental mishandling of the device may have resulted in inaccurate dosing in a small number of cases. The device was modified and the modifications were submitted to the FDA. The ForadilÂ® Certihaler(TM) has been approved in 27 countries outside the USA, and SkyePharma is in discussion with Novartis with respect to commercial launch in these territories. SkyePharma earns a royalty on sales of FORADILÂ® CERTIHALER(TM) in all markets. SkyePharma also manufactures and supplies the FORADILÂ® CERTIHALER(TM). Frank Condella, CEO, SkyePharma said: "We are extremely pleased by the FDA's decision to approve the modifications to FORADILÂ® CERTIHALER(TM). We believe that this approval validates SkyePharma's inhalation technology and paves the way to future products." For further information please contact: SkyePharma PLC +44 207 491 1777 Frank Condella, Chief Executive Officer Ken Cunningham, Chief Operating Officer Buchanan Communications +44 207 466 5000 Tim Anderson / Mark Court / Rebecca Skye Dietrich The Trout Group + 1 617 583 1308 Seth Lewis Notes for editors About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now eleven approved products incorporating SkyePharma's technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit www.skyepharma.com. Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma's 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma's ability to manufacture products on a large scale or at all, risks related to SkyePharma's and its marketing partners' ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma's ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.