RNS Number:7395P
Skyepharma PLC
15 September 2003

For Immediate Release                                         15 September, 2003

                    SkyePharma's partner Astralis initiates
                 US phase I trial for novel psoriasis treatment

LONDON, ENGLAND, September 15, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
welcomes the recent announcement by its partner Astralis Ltd (OTCBB: ASTR -
News) that it has initiated a Phase I clinical trial in the USA for
PsoraxineTM, a novel injectable treatment for moderate psoriasis, a common
chronic skin condition. A first generation version of PsoraxineTM has already
been studied extensively in Venezuela, where nearly 3,000 patients participated
in open-label clinical studies, the vast majority showing a positive response
with few side-effects. Through a service agreement, SkyePharma is providing
development, manufacturing, pre-clinical and clinical development services to
Astralis for a second generation version of PsoraxineTM, up to the completion
of Phase II clinical studies. In the event that Phase II studies are
successfully completed, Astralis will offer SkyePharma the option to acquire the
worldwide licensing and distribution rights to PsoraxineTM. SkyePharma has a
minority equity stake in Astralis.

Michael Ashton, SkyePharma's Chief Executive, said "We are delighted that the US
Food & Drug Administration has authorised the start of US clinical studies of
PsoraxineTM. We look forward to working with our partner Astralis to validate
the very promising results from the previous studies in Venezuela. Psoriasis
remains a common and highly debilitating condition with well-recognised failings
in standard treatments. Despite the recent introduction of some new approaches
to psoriasis, there remains a substantial opportunity for a safe and effective
new therapy."

The double-blind, placebo-controlled US study is being conducted by Dr. William
Abramovits, Professor of Dermatology at Baylor University Medical Center,
Dallas, Texas. The trial will evaluate the safety of a single dose of
PsoraxineTM in patients with moderate psoriasis that has lasted for more than
three months and covers between 3% and 15% of the body surface. PsoraxineTM is
administered by intramuscular injection and the trial will encompass three dose
ranges of 50, 150, and 300 micrograms in addition to a placebo control arm. The
study will also provide some preliminary information on efficacy using measures
of psoriasis severity and Quality of Life improvement.


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 psoriasis
Psoriasis is a chronic, genetically linked skin disorder that affects
approximately 2-3% of the world's population. For example, there are 7 million
patients in the USA, with around 250,000 new cases diagnosed every year. The
prevalence in Europe is similar. About 25% of patients are classified as
moderate to severe, with over 10% of their body area affected. Psoriasis
symptoms result from the overproduction of skin by epidermal cells induced by
cells from the immune system. These blood cells over-stimulate the epidermis and
act as though the skin was damaged, manufacturing skin cells at a much faster
rate than is required by undamaged skin. The overproduction of skin cells can
cause symptoms ranging from itchy rash-like patches to painful plaques or
pustules, accompanied by massive inflammation.

Psoriasis is normally episodic, with patients experiencing flares of increasing
severity followed by periods of remission. Disease severity in psoriasis is
measured by the PASI (Psoriasis Area and Severity Index) score, based on
subjective assessment by the patient and objective measurements by the
clinician. The PASI score ranks from 0-72 with zero indicating symptom-free. The
FDA hurdle for demonstrating the efficacy of psoriasis treatments is a 75%
reduction in PASI score.


About PsoraxineTM

PsoraxineTM is a protein-based therapy that is believed to stimulate cells from
the patient's immune system to reverse the inflammatory process responsible for
psoriasis symptoms. Jose O'Daly MD, PhD, Chairman of the Board and Head of R&D
for Astralis, is a Venezuelan parasitologist. While developing an improved
vaccine for leishmaniasis, a parasitic infection transmitted by sandflies and
endemic in much of South America, he noticed that vaccinated patients with
psoriasis saw their symptoms resolve. The version of PsoraxineTM used in the
clinical studies in Venezuela was based on a cellular extract from several
species of the Leishmania parasite. Since 1992, nearly 3,000 patients have been
treated with a course of injections in open-label studies. A clinically
significant reduction in PASI score was reported for a great majority of the
patients treated. The only significant side-effect in these studies was pain at
the injection site. The second generation version of PsoraxineTM to be used in
the US trials is a purified protein fraction.


About Astralis

Astralis Ltd, an emerging biotechnology company based in Fairfield, New Jersey,
focuses on the research and development of novel treatments for immune system
disorders and skin diseases. For further information visit  
www.astralisltd.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                                         +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications

Sandra Haughton, US Investor Relations                 +1 212 753 5780

Buchanan Communications                                +44 207 466 5000
Tim Anderson / Rebecca Skye Dietrich

Astralis Ltd
Mike Ajnsztajn, Chief Executive Officer                +1 973 227 7168
Gina Tedesco, Chief Financial Officer


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