SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of June, 2005
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
FOR IMMEDIATE RELEASE 28 June 2005 SkyePharma PLC First European Filing for New Aerosol Inhaler Version of AstraZeneca's Pulmicort® LONDON, ENGLAND, 28 June, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces today that a new pressurized metered-dose aerosol inhaler (pMDI) formulation of the inhaled corticosteroid Pulmicort® (budesonide) has been filed by AstraZeneca in its first European market. Pulmicort® HFA-pMDI will be available in two strengths, 100 ug and 200 ug, and will be used for the treatment of asthma in adults and children. The currently available pMDI formulation of Pulmicort® has been on the market since 1981 and uses chlorofluorocarbons (CFCs) as the propellant. In accordance with the Montreal Protocol, this will now be replaced by a non-ozone depleting device using hydrofluoroalkanes (HFA) as propellant. SkyePharma developed the new HFA pMDI device, which employs its proprietary formulation technology, and SkyePharma also conducted the clinical development programme for AstraZeneca. The filing triggers a milestone payment to SkyePharma, which will also earn a royalty on AstraZeneca's sales of this formulation of Pulmicort®. Michael Ashton, SkyePharma's Chief Executive, said: "We are delighted that Pulmicort® HFA pMDI has successfully completed clinical development and now been filed. This is another example of the growing family of products based on our portfolio of pulmonary delivery technologies." 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 Notes to 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. About Pulmicort® Pulmicort® (budesonide) is an inhaled corticosteroid indicated for maintenance treatment of asthma in children and adults. In some countries Pulmicort® is also indicated for maintenance treatment of Chronic Obstructive Pulmonary Disease ("COPD"). Pulmicort® was first registered and launched in 1981 and is now approved in 89 countries. Pulmicort® is available in three administration forms, a dry powder inhaler (Pulmicort® Turbuhaler®), as a nebulising suspension (Pulmicort® Respules®) and as a pressurized Metered-Dose inhaler (Pulmicort® pMDI). Pulmicort® is a trademark of the AstraZeneca group of companies 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. END
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: June 28, 2005