RNS Number:1760M
Skyepharma PLC
11 June 2003


For Immediate Release:                               11 June 2003



                     SKYEPHARMA RESEARCH & DEVELOPMENT DAY

          New Data on DepoMorphine and Propofol IDD-D to be Presented


LONDON, ENGLAND, June 11, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) is
today presenting an update on its Research and Development programmes. The
presentation provides institutional shareholders and sector analysts with an
update on the Group's extensive product pipeline and features clinical
development updates on its lead pipeline products, DepoMorphine and Propofol
IDD-D, as well as details of the product portfolio including both internally
developed products and those developed for SkyePharma's clients.


The presentation begins with a brief introduction by Michael Ashton,
SkyePharma's Chief Executive Officer, who provides an overview on the Group's
major marketed products: Paxil CR, a controlled-release version of
GlaxoSmithKline's antidepressant Paxil; Solaraze for actinic keratosis (marketed
by Quintiles Transnational in North America and by Shire Pharmaceuticals in
Europe); Xatral OD, a once-daily version of SanofiSynthelabo's Xatral for
urinary difficulties associated with benign prostatic hypertrophy; and Depocyt,
a controlled-release injectable formulation of cytarabine for lymphomatous
meningitis, marketed in North America by Enzon.


This is followed by a series of presentations from SkyePharma's senior
management.


*    New Phase III trial data on DepoMorphine to be presented.


SkyePharma's novel controlled-release injectable formulation of morphine for
control of post-operative pain. DepoMorphine, is given as a single epidural
injection before surgery and provides highly effective pain relief for 48 hours,
the period of peak pain after an operation. By contrast conventional morphine
only provides pain relief for up to 12 hours and repeat administration normally
requires catheters and infusion pumps that are a frequent source of problems. Dr
Gordon Schooley, head of clinical development for SkyePharma, reviews the
clinical development programme for DepoMorphine which involved four separate
pain models involving nearly 1000 patients. In the two pivotal trials, in hip
surgery and lower abdominal surgery, DepoMorphine demonstrated sustained
dose-related analgesia and achieved its primary endpoint (superiority over study
comparators in terms of total demand for opioid analgesics after surgery) with a
high degree of statistical significance. DepoMorphine also achieved statistical
significance on several secondary endpoints such as patient perception of pain
intensity and adequacy of pain relief. In two related Phase IIb trials,
DepoMorphine was significantly better than study comparators in the caesarean
section study and approached statistical significance in the knee arthroplasty
study. In the latter study, the primary endpoint was recalled pain intensity.
DepoMorphine did achieve a high degree of statistical significance in total
demand for opioid analgesics after surgery, a secondary endpoint in this trial
but the primary endpoint in the three other studies. SkyePharma expects to file
DepoMorphine with the FDA around the middle of this year and with the European
agency in September. DepoMorphine was licensed to Endo Pharmaceuticals for North
America at the end of 2002. SkyePharma expects to appoint licensees in other
territories this year.


*      New Phase II clinical data Propofol IDD-D 2%, a new proprietary
formulation of the injectable anaesthetic and sedative propofol.



The global market for AstraZeneca's Diprivan and some generic versions was $650
mn in 2002. The SkyePharma formulation cannot support microbial growth, a
recognized problem with current versions that requires opened vials and
contaminated tubing to be disposed of after 8-12 hours. Propofol IDD-D 2% should
provide uninterrupted sedation for 24 hours, avoids the need for preservatives
and reduces the risks of hyperlipidemia and fluid overload associated with
current versions of propofol. In the recently completed Phase II trial, the
SkyePharma version was shown to be similar to Diprivan in terms of
pharmacokinetics, anaesthetic efficacy and safety. Propofol IDD-D 2% will
commence Phase III trials, involving over 700 patients, by the end of 2003.
Propofol IDD-D 2% was licensed to Endo Pharmaceuticals for North America at the
end of 2002. SkyePharma expects to appoint licensees in other territories later
this year.



This is followed by an overview of SkyePharma's pulmonary product pipeline. This
includes a dry-powder inhaler version of Novartis' bronchodilator Foradil which
was filed with the FDA and European authorities in December 2002. Dr
Niederlander, head of SkyePharma's pulmonary unit in Basel, Switzerland, also
reviews an HFA aerosol inhaler version of formoterol (due to enter Phase III
trials later this year); an HFA aerosol inhaler version of budesonide
(AstraZeneca's Pulmicort) which will also enter Phase III trials later this
year; and an HFA aerosol inhaler containing a fixed dose combination of
formoterol and fluticasone (to move into Phase II development in the second
half).



Dr Richard Jones, head of R&D, will then present SkyePharma's controlled-release
injectable delivery technologies DepoFoam and Biosphere and their application to
the delivery of biologics. Protein drugs do not survive the digestive system and
so cannot be taken orally but injections are unpopular with patients.
SkyePharma's two complementary protein delivery technologies reduce injection
frequency and provide scope for improved products that overcome some of the
limitations of current protein drugs. Proof of principle has recently been
published and SkyePharma is currently in negotiations with various potential
partners.



Dr Paul Wotton, SKP's head of Business Development, presents an outline of the
company's Business Development strategy and CEO Michael Ashton concludes with a
summing up.



The presentation will commence at 09.45 a.m. BST at Salters Hall, Fore Street,
London, EC2Y 5DE. This meeting will be webcast live on www.skyepharma.com.



On Thursday, June 12th, SkyePharma will also host a lunch presentation in New
York for its U.S. audience at the St. Regis Hotel, 2 East 55th Street at 5th
Avenue, commencing at 11.45 a.m EDT.



SkyePharma PLC 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 delivery technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
SkyePharma has two FDA- and EMA-approved manufacturing plants in San Diego, USA,
and Lyon, France.  For more information, visit www.skyepharma.com


For further information please contact:


SkyePharma Plc                                             + 44 (0) 207 491 1777
Peter Laing, Director of Corporate Communications

US Investor Relations                                         + 1 (212) 753-5780
Sandra Haughton

Buchanan Communications                                     +44 (0) 207 466 5000
Tim Anderson  / Nicola How




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