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 September, 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 7 September 2005
SkyePharma PLC
FORADIL® CERTIHALER™ LAUNCHED IN GERMANY
LONDON, UK, 7 September 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces today that its partner Novartis Pharma AG
(Novartis) has launched FORADIL® CERTIHALER™ (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® CERTIHALER™ in
June. FORADIL® CERTIHALER™ is a trademark of Novartis. FORADIL® CERTIHALER™, 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® CERTIHALER™ 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® franchise has been licensed by Novartis to Schering-Plough Corporation.
Michael Ashton, SkyePharma's Chief Executive Officer, commented: "We are delighted that FORADIL® CERTIHALER™ has now reached the
market in Germany, and we expect patients to appreciate the design features in this sophisticated and reliable device."
FORADIL® CERTIHALER™ embodies two proprietary SkyePharma technologies, the SKYEHALER™, a novel breath-actuated multi-dose dry powder
inhaler ("MDDPI") device, and SKYEPROTECT™, 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® CERTIHALER™, 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® CERTIHALER™ dry-powder inhaler contains 60 doses, giving
patients the convenience of 30 days of therapy in a single inhaler. This evolution of the FORADIL® 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® CERTIHALER™ in all markets. SkyePharma will also manufacture and supply
FORADIL® CERTIHALER™.
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
Notes to Editors
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 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.
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: September 7, 2005