SkyePharma Announces FORADIL(R) CERTIHALER(TM) Launched in Germany

LONDON, Sept. 7 /PRNewswire-FirstCall/ — SkyePharma PLC announces today that its partner Novartis Pharma AG (Novartis) has launched FORADIL(R) CERTIHALER(TM) (formoterol fumarate inhalation powder) on the German market for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The German pharmaceutical regulatory authority approved FORADIL(R) CERTIHALER(TM) in June. FORADIL(R) CERTIHALER(TM) is a trademark of Novartis. FORADIL(R) CERTIHALER(TM), co-developed by SkyePharma PLC and Novartis, 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 now been approved in five countries in Latin America and in South Africa. FORADIL(R) CERTIHALER(TM) 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 has provided the agency with additional data that were requested. The US FORADIL(R) franchise has been licensed by Novartis to Schering-Plough Corporation.

Michael Ashton, SkyePharma’s Chief Executive Officer, commented: “We are delighted that FORADIL(R) CERTIHALER(TM) has now reached the market in Germany, and we expect patients to appreciate the design features in this sophisticated and reliable device.”

FORADIL(R) CERTIHALER(TM) embodies two proprietary SkyePharma technologies, the SKYEHALER(TM), a novel breath-actuated multi-dose dry powder inhaler (“MDDPI”) device, and SKYEPROTECT(TM), 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(R) CERTIHALER(TM), is a long-acting beta2-agonist bronchodilator that combines a rapid onset of action (within 5 minutes) with a long-lasting bronchodilation effect for 12 hours. This feature offers important benefits for patients who suffer from asthma and COPD. The breath-actuated FORADIL(R) CERTIHALER(TM) dry-powder inhaler contains 60 doses, giving patients the convenience of 30 days of therapy in a single inhaler. This evolution of the FORADIL(R) line was developed to provide a valuable and convenient option for asthma and COPD patients who require maintenance therapy with a long-acting bronchodilator.

SkyePharma will earn a royalty on future sales of FORADIL(R) CERTIHALER(TM) in all markets. SkyePharma will also manufacture and supply FORADIL(R) CERTIHALER(TM).

   For further information please contact:    SkyePharma PLC    +44 207 491 1777    Michael Ashton, Chief Executive Officer    Peter Laing, Director of Corporate Communications    +44 205 491 5124    Sandra Haughton, US Investor Relations    +1 212 753 5780    Buchanan Communications    +44 207 466 5000    Tim Anderson / Mark Court / Rebecca Skye Dietrich   

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 and marketed products incorporating SkyePharma’s technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit http://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.

SkyePharma PLC

CONTACT: SkyePharma PLC, +44-207-491-1777, or Michael Ashton, ChiefExecutive Officer, or Peter Laing, Director of Corporate Communications,+44-205-491-5124, or Sandra Haughton, US Investor Relations, +1-212-753-5780,all of SkyePharma PLC, or Tim Anderson, Mark Court or Rebecca Skye Dietrich,+44-207-466-5000, all of Buchanan Communications for SkyePharma PLC

Web site: http://www.skyepharma.com/