RNS Number:0914U
Skyepharma PLC
12 January 2004


For Immediate Release                                    12 January, 2004



                                 SkyePharma PLC

                               Press Announcement



              SkyePharma Welcomes Canadian Approval of Paxil CR(TM)



LONDON, ENGLAND, January 12, 2004 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
welcomes the recent announcement by GlaxoSmithKline (NYSE: GSK) that the
Therapeutic Products Directorate of Health Canada has approved Paxil CR(TM)
(paroxetine hydrochloride Controlled Release tablets) for the treatment of
depression, panic disorder and social anxiety disorder. Paxil CR(TM), a
selective serotonin reuptake inhibitor (SSRI) antidepressant, is already
approved and marketed in the US for the treatment of major depressive disorder,
panic disorder, premenstrual dysphoric disorder (PMDD) and, most recently,
social anxiety disorder and is currently under FDA review for the intermittent
treatment of PMDD. SkyePharma developed the controlled release formulation used
in Paxil CR(TM) and receives a royalty on GlaxoSmithKline's sales.



Michael Ashton, SkyePharma's chief executive officer, commented: "We are pleased
by this additional market opportunity for Paxil CR(TM). Clinical studies have
demonstrated that Paxil CR(TM) significantly reduces the incidence of nausea, a
common and troublesome side-effect in the first few weeks of treatment that
results in poor compliance with many SSRI antidepressants. The low drop-out rate
for patients on Paxil CR(TM) may increase the likelihood that patients will
obtain the full therapeutic benefit. Paxil CR(TM) currently accounts for about
one in twelve new US prescriptions for SSRI antidepressants and we hope for a
similar level of success in Canada."



To develop Paxil CR(TM), GlaxoSmithKline's antidepressant Paxil(R) was
reformulated using SkyePharma's Geomatrix(TM) oral drug delivery technology in
which a multi-layered tablet controls the rate of dissolution and site of
absorption of the drug in the body. GlaxoSmithKline launched Paxil CR(TM) in the
US in April 2002. Paxil CR(TM) offers flexible dosing and in Canada will be
available in two different dosing strengths: 12.5 mg and 25 mg.



About SkyePharma

SkyePharma PLC uses its world-leading drug delivery technology to develop
easier-to-use and more effective formulations of drugs. The majority of
challenges faced in the formulation and delivery of drugs can be addressed by
one of the Company's proprietary technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
For more information, visit http://www.skyepharma.com.



About Geomatrix(TM)

Geomatrix(TM) controlled release systems control the amount, timing and location
of drug release into the body. This is achieved by constructing a tablet with
two basic components: a core containing the active drug or drugs, and one or two
additional barrier layers that control the drug's diffusion out of the core.
Tablets with a wide range of predictable and reproducible drug release profiles
can be made by combining different chemical components in the core and barrier
layers, each with a different rate of swelling, gelling and erosion.



Except for the historical information herein, the matters discussed in this news
release include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, market a pharmaceutical product on a large scale and
integrate and manage an internal sales and marketing organization and maintain
or expand sales and market share for its products, risks relating to the ability
to ensure regulatory compliance, risks related to the research, development and
regulatory approval of new pharmaceutical products, risks related to research
and development costs and capabilities, market acceptance of and continuing
demand for SkyePharma's products and the impact of increased competition, risks
associated with anticipated top and bottom line growth and the possibility that
upside potential will not be achieved, competitive products and pricing, and
risks associated with the ownership and use of intellectual property rights.
SkyePharma undertakes no obligation to revise or update any such forward-looking
statement to reflect events or circumstances after the date of this release.



For further information please contact:


SkyePharma PLC                                             +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications          +44 207 491 5124

Sandra Haughton, US Investor Relations                     +1 212 753 5780

Buchanan Communications                                    +44 207 466 5000
Tim Anderson / Mark Court




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            The company news service from the London Stock Exchange
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