FDA Approval

RNS Number:0637R
Skyepharma PLC
20 October 2003


For Immediate Release                                           20 October, 2003



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


            Paxil CR(TM) Becomes the First and Only Controlled-Release
            SSRI Antidepressant Approved for Social Anxiety Disorder



LONDON, ENGLAND, October 20, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
welcomes the recent announcement by its partner GlaxoSmithKline (NYSE: GSK),
that the US Food & Drug Administration ("FDA") has approved an additional
therapeutic indication for Paxil CR(TM) (paroxetine hydrochloride Controlled
Release) for the treatment of social anxiety disorder. Paxil CR(TM) is already
approved and on the market in the US for the treatment of depression, panic
disorder and, most recently, premenstrual dysphoric disorder (PMDD). SkyePharma
developed the controlled release formulation used in Paxil CR(TM) and receives a
royalty on GlaxoSmithKline's sales.



Social anxiety disorder ("SAD", also known as social phobia) is a condition in
which affected individuals have an intense and exaggerated fear of scrutiny by
other people in common everyday social interaction situations such as meetings,
parties, speaking in public and talking to strangers or authority figures.
Affected individuals exhibit symptoms such as rapid heartbeat, tremor, nausea
and diarrhoea in these circumstances, often leading them to avoid such
situations altogether, thereby adversely affecting their life, work and social
relationships. This highly debilitating condition is believed to affect more
than 10 million Americans and is the third most common psychiatric disorder
behind depression and alcoholism. Despite the devastating consequences of SAD,
relatively few patients are diagnosed and most are not even aware that this is a
medical condition that can be treated successfully. Paxil CR(TM) is the first
and only controlled-release selective serotonin reuptake inhibitor (SSRI)
antidepressant to be approved for treating SAD. The low level of treatment-
associated side-effects with Paxil CR(TM) is expected to contribute to the
effectiveness of therapy since adverse events are a major factor behind the
recognised problem of poor compliance with other antidepressants.



Michael Ashton, SkyePharma's chief executive officer, commented "We are
extremely excited by this recent milestone, which is testimony to the breadth of
therapeutic efficacy for Paxil CR(TM) when targeting incapacitating depressive
conditions such as SAD. Even though SAD is a common condition, it is
under-treated, with less than 1% of all US prescriptions for SSRI
antidepressants currently being written for SAD, so we believe that there is a
substantial opportunity for a superior treatment. Based on US IMS data through
August 2003, 72% of all prescriptions for SAD involve an SSRI antidepressant,
and nearly 30% of SSRI prescriptions for the condition are already written for
Paxil CR(TM). Clinical studies have demonstrated that Paxil CR(TM) significantly
reduces the incidence of nausea in the first few weeks of treatment, 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. We look
forward to a similar regulatory outcome for the remaining indication of Paxil CR
(TM) still under review, intermittent treatment of PMDD.''



Data from a 12 week multi-center, double-blind placebo-controlled trial was
presented by GlaxoSmithKline at the 156th annual meeting of the American
Psychiatric Association in San Francisco in May 2003. 370 patients diagnosed
with SAD were given a flexible dose regimen of Paxil CR(TM) (12.5 mg - 37.5 mg
per day) or placebo. The two primary efficacy variables were the mean change
from baseline in the Liebowitz Social Anxiety Scale (LSAS) and percent of
responders defined by a CGI-Global Improvement score of one (very much improved)
or two (much improved). The Sheehan Disability Scale (SDS) was also utilized to
measure functional impairment. Paxil CR(TM) resulted in statistically
significant improvement in symptoms from placebo in the efficacy scales and
significant improvements were seen in total functional impairments measures as
well as each of the subcategories: family life, work life and social life.
Additional results from this study demonstrated that Paxil CR(TM) achieved high
remission rates. Furthermore Paxil CR(TM) was well-tolerated, with a low patient
drop-out rate due to adverse events comparable with placebo (3% vs. 2%).



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 FDA for the
treatment of major depressive disorder, panic disorder and continuous
premenstrual dysphoric disorder (PMDD). 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 sales of Paxil CR(TM))
were US$1.07 billion. The FDA is currently reviewing Paxil CR(TM) as an
intermittent treatment for PMDD.


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 / Mark Court


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