Paxil CR New Indication

RNS Number:3167P
Skyepharma PLC
03 September 2003

For Immediate Release                                          3 September, 2003


                        SkyePharma Welcomes FDA Approval
                       of New Indication for Paxil CR(TM)


LONDON, ENGLAND, September 3, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
welcomes yesterday's announcement by its partner GlaxoSmithKline that the US
Food & Drug Administration ("FDA") has approved an additional therapeutic
application for Paxil CR(TM) (paroxetine hydrochloride Controlled Release) for
the treatment of premenstrual dysphoric disorder ("PMDD"). Paxil(R) is a
leading selective serotonin reuptake inhibitor ("SSRI") antidepressant and Paxil
CR(TM) is already on the market in the US for the treatment of depression and
panic disorder. SkyePharma developed the controlled release formulation used in
Paxil CR(TM) and receives a royalty on GlaxoSmithKline's sales.

In studies on the use of Paxil CR(TM) in the treatment of PMDD reported at the
156th Annual Meeting of the American Psychiatric Association in San Francisco
(22nd-24th May), over 1000 patients were enrolled in three separate studies and
were treated with either Paxil CR(TM) at a daily dose of 12.5 or 25 mg or with
placebo. Even at the lowest dose, there was a significant improvement in
patients' emotional and physical symptoms over placebo and the drug was well
tolerated. PMDD is a condition that affects about 5% of menstruating women and
is characterised by severe and disabling mood swings and physical symptoms
around the end of the menstrual cycle.

In Paxil CR(TM) GlaxoSmithKline's leading 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
USA in April 2002. Paxil CR(TM) is currently approved by the U.S. Food and Drug
Administration (FDA) for the treatment of major depressive disorder and panic
disorder. Paxil CR(TM) offers flexible dosing and is available in three 
different dosing strengths: 12.5 mg, 25 mg and 37.5 mg. In the first half of 
2003, US sales of Paxil(R) (including Paxil CR(TM)) were US$1.07 billion. 
SkyePharma receives ongoing royalty payments on GlaxoSmithKline's net sales of 
Paxil CR(TM). The FDA is currently reviewing Paxil CR(TM) as a treatment for 
social anxiety disorder and for the intermittent dosing of PMDD.

Michael Ashton, SkyePharma's chief executive officer commented, "Paxil CR(TM),
the flagship of our Geomatrix(TM) oral drug delivery platform technology, has
been very successful since its US launch last year. According to IMS market
data, Paxil CR(TM) currently accounts for over 38% of new prescriptions and over
30% of all prescriptions for the entire Paxil(R)/Paxil CR(TM) franchise in the
U.S. Clinical studies have demonstrated that Paxil CR(TM) significantly reduces
the incidence of nausea, a common and troublesome side-effect 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. The PMDD indication for Paxil CR(TM) should expand
the market opportunity for the product since the older version of Paxil(R) was
never approved for this indication.''

Notes to Editors

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.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and
health care companies, is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further information
visit http://www.gsk.com.

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                                             [phone]
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications

Sandra Haughton, US Investor Relations                     [phone]

Buchanan Communications                                    [phone]
Tim Anderson / Rebecca Skye Dietrich



                      This information is provided by RNS
            The company news service from the London Stock Exchange
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