Result of Expert Report

RNS Number:4829T
Skyepharma PLC
19 December 2003


For Immediate Release                                          19 December, 2003

                                 SkyePharma PLC


   NEW STUDY SHOWS PATIENTS TREATED WITH PAXIL(R) CR FOR DEPRESSION ARE LESS
                         LIKELY TO DISCONTINUE THERAPY

LONDON, UK, 19 December 2003 -- SkyePharma PLC (LSE: SKP, Nasdaq: SKYE) welcomes
the publication of a new study in the December 2003 issue of "Managed Care
Interface" showing that patients with depression who were prescribed
controlled-release paroxetine (GlaxoSmithKline's Paxil(R) CR) were less likely
to discontinue therapy than patients receiving immediate-release selective
serotonin reuptake inhibitors (SSRIs). Paxil(R) CR, a modified version of
GlaxoSmithKline's SSRI antidepressant Paxil(R), incorporates SkyePharma's
Geomatrix(TM) oral controlled release delivery technology. Paxil(R) CR was
designed to reduce the incidence of nausea, the most common side-effect of SSRI
antidepressants, especially in patients initiating therapy. Paxil(R) CR has
been available in the US market since April 2002 and SkyePharma receives a
royalty on GlaxoSmithKline's sales. In the three months ending 30 September
2003, sales of Paxil(R) CR were #110 million ($177 million), representing 30%
of the US Paxil(R)/Paxil(R) CR franchise total.

The database study looked at more than 80,000 patients in managed care
organizations across the United States and found that patients taking
controlled-release paroxetine were 28 percent less likely to discontinue therapy
during a 180-day period than patients taking immediate-release SSRIs. American
Psychiatric Association (APA) treatment guidelines recommend that patients with
depression remain on antidepressant therapy for a minimum of six months. However
more than 40 percent of patients discontinue treatment within the first 90 days.

The clinical benefit of increased length of treatment is well-documented,
indicating that depression and/or anxiety relapses are less likely with patients
who remain on therapy longer. A decrease in relapse rates could substantially
reduce the current costs associated with this disease in America, which
currently total in excess of $80 billion annually. Previously-published clinical
trial data1 shows that controlled-release paroxetine is associated with improved
tolerability and a lower adverse event drop-out rate as compared with
immediate-release paroxetine, suggesting a rationale for the extended treatment
duration of patients taking controlled-release paroxetine.

"With controlled-release paroxetine, more patients remain on therapy during the
critical maintenance-phase period than with immediate-release SSRIs, enhancing
the quality of depression management," said Dr. Quentzel, Chief of Primary Care
Psychiatry at Beth Israel Medical Center in New York, NY. "Controlled-release
paroxetine offers primary care physicians and mental health providers an
encouraging option to help reduce treatment discontinuation."

The study examined claims data obtained from the PharMetrics Integrated Outcomes
Database, including data from 61 different managed care organizations,
encompassing more than 36 million lives and nearly 1 billion claims. Patients
were required to be at least 18 years of age and to have six months of enrolment
before their index date, defined as the date of the first SSRI prescription.
Only patients experiencing new therapy with SSRIs between April 1, 2002 and
December 31, 2002 were included in the study. A total of 82,337 patients were
eligible for study inclusion. Most patients had prescriptions for sertraline
(Pfizer's Zoloft(R)), followed by immediate-release paroxetine
(GlaxoSmithKline's Paxil(R), now also available generically), citalopram
(Forest Laboratories' Celexa), and fluoxetine (Eli Lilly's Prozac(R), now also
available generically). Eight percent of eligible patients received
controlled-release paroxetine (GlaxoSmithKline's Paxil(R) CR).

In the time-to-discontinuation analysis, patients were deemed to have
discontinued therapy when more than 15 days beyond the days' supply elapsed
between prescriptions. The discontinuation analysis indicated that patients
receiving controlled-release paroxetine were 28 percent less likely to
discontinue therapy as compared with patients receiving immediate-release SSRIs.
Furthermore, during the 180-day follow-up period, patients receiving
controlled-release paroxetine were 16.5 percent less likely to switch or augment
therapy as compared with patients receiving immediate-release SSRIs.

"Not only does non-compliance in antidepressant therapy make it more difficult
to effectively treat patients, but early therapy change or discontinuation also
places a financial burden on the health system." said investigator Timothy
Regan, Senior Manager with Applied Health Outcomes, the outcomes research firm
that conducted the study. "The improvements in length of therapy seen with
controlled-release paroxetine are expected to yield substantial economic and
clinical benefits for patients and managed care organizations."

1 Golden et al., J. Clin. Psychiatry, 63:7 (July 2002)


Notes for Editors:

About SkyePharma

SkyePharma develops pharmaceutical products benefiting from world-leading drug
delivery technologies that provide easier-to-use and more effective drug
formulations. There are now nine approved products incorporating three of
SkyePharma's five technologies in the areas of oral, injectable, inhaled and
topical delivery, supported by advanced solubilisation capabilities. For more
information, visit 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 drugs' 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 Managed Care Interface

Managed Care Interface, launched in 1988, is a monthly peer-reviewed journal for
the US managed care industry. Each month, Managed Care Interface publishes fully
refereed articles in a broad spectrum of interest, including Pharmacy Practice,
Pharmacoeconomics, Disease Management, and Health Care Policy.

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              [phone]
Sandra Haughton, US Investor Relations                         [phone]

Buchanan Communications                                        [phone]
Tim Anderson / Mark Court


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