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 Welcomes Return of Paxil CR™ to US Market
LONDON, ENGLAND, 28 June, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
welcomes the announcement by its partner GlaxoSmithKline ("GSK") that Paxil
CR™ is now available at pharmacies throughout the United States.
Michael Ashton, SkyePharma's Chief Executive, said: "Paxil CR™ was designed
to address the side-effect of early nausea that affects many patients being
treated with SSRI antidepressants so its return to the US market fills an
obvious therapeutic gap. Paxil CR™ was our most important source of royalty
income in 2004. We are confident that a rebuild in US revenues, and the new
higher royalty rate, will mean that it will also be the major source of royalty
income in 2005."
On 4 March 2005, the US Food & Drug Administration ("FDA") halted distribution
of supplies of Paxil CR™, and another unrelated product, from GSK's
manufacturing plant at Cidra, in Puerto Rico, and from distribution depots,
thereby halting US distribution of Paxil CR™. Both GSK and the FDA agreed at
the time that manufacturing issues cited by the FDA posed no significant safety
issue for patients. On 28 April 2005, SkyePharma announced that it had entered
into an amendment agreement with GSK whereby the royalty rate payable on GSK's
sales of Paxil CR™ was increased from 3% to 4%. GSK also agreed to maintain
royalty payments while the product was off the market.
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 Paxil CR™
In March 1996, SkyePharma entered into a License Agreement with SmithKline
Beecham (now part of GlaxoSmithKline) for the development, manufacture and
marketing of a modified release version of Paxil®/Seroxat® (paroxetine
hydrochloride) using a combination of SkyePharma's Geomatrix™ Positioned
Release and Zero Order systems. Paxil® is an FDA-approved antidepressant drug
that is currently marketed primarily in the United States and Europe (where it
is known as Seroxat®) and is an immediate release formulation prescribed for
central nervous system disorders. Paxil CR™ was approved by the FDA in
February 1999 for the treatment of depression. Subsequently Paxil CR™ has
been approved by the FDA for four additional indications: panic disorder, the
continuous treatment of Pre-Menstrual Dysphoric Disorder (PMDD), social anxiety
disorder and the intermittent treatment of PMDD.
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.
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