RNS Number:0446Q
Skyepharma PLC
23 September 2003


For Immediate Release                             23 September, 2003



             SkyePharma's New Drug Application for DepoMorphineTM
              Accepted for Filing by US Food & Drug Administration

LONDON, ENGLAND, September 23, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announced today that on 16 September the US Food & Drug Administration ("FDA")
formally accepted for filing a New Drug Application ("NDA") for DepoMorphineTM,
SkyePharma's novel sustained-release injectable formulation of morphine for
control of moderate-to-severe post-operative pain. SkyePharma submitted the NDA
on 18 July. DepoMorphineTM was licensed to Endo Pharmaceuticals Inc. ("Endo",
Nasdaq: ENDP) for North America at the end of 2002. Under the terms of this
licence agreement, the FDA's acceptance of the DepoMorphineTM submission
triggers a US$5 million milestone payment from Endo to SkyePharma.

SkyePharma's Chief Executive Michael Ashton said, "DepoMorphineTM is currently
our most important pipeline product. We now look forward to its
commercialisation, which we anticipate in the second half of 2004. Our clinical
trials show that DepoMorphineTM has the potential to improve the treatment of
pain after surgery. There is widespread recognition that pain relief is an
under-served market and current approaches to control of post-operative pain
leave much to be desired."

DepoMorphineTM employs SkyePharma's proprietary DepoFoamTM technology and is
supplied as a ready-to-use suspension. It is given as a single epidural
injection before or during surgery and provides pain relief for 48 hours
following surgery. There is no need for an indwelling catheter for continuous
infusion, which overcomes a major drawback to the epidural route of
administration for opioids.

DepoMorphineTM is designed for the control of moderate-to-severe post-operative
pain. SkyePharma expects that its main use will be in control of post-operative
pain in hospitalised patients undergoing surgical procedures requiring general
or local anaesthesia such as major abdominal surgery, orthopaedic surgery and
caesarean section. Currently there are an estimated 6 million such procedures
every year in the USA and 5 million in Europe.

SkyePharma has completed seven clinical trials of DepoMorphineTM. The Phase IIb
and Phase III clinical development programme for DepoMorphineTM involved four
separate pain models and included nearly 1000 patients.

SkyePharma plans to file DepoMorphineTM with the European Agency for the
Evaluation of Medicinal Products (EMEA) in the autumn. SkyePharma expects to
announce the appointment of licensees for DepoMorphineTM in Europe and other
non-US territories later this year.

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 DepoFoamTM

DepoFoamTM is SkyePharma's proprietary sustained-release injectable delivery
technology. This is fully commercialised and approved by regulatory agencies in
both the USA and Europe. DepoFoamTM consists of tiny lipid-based particles
containing discrete water-filled chambers dispersed through the lipid matrix.
The particles are 10-30 microns in diameter and are suspended in saline. The
suspension resembles skimmed milk and can be injected through a fine needle. The
water-filled chambers containing active drug account for most of the weight of
the particles. The lipids are naturally occurring substances (or close
analogues) such as phospholipids and triglycerides. The small amount of lipid is
cleared rapidly in the body as the particles deliver their drug payload over a
period that can be modified from 1 to 30 days. For example in DepoCyt(R)/
DepoCyte(R) the circulating half-life of the drug cytarabine is increased from
3.4 hours to 141 hours.

About post-operative pain

After a major surgical operation, the level of pain is usually very high for the
first one to two days but the intensity of pain gradually subsides and by the
end of the second day pain can normally be controlled with oral analgesics. For
the immediate post-operative period, opioid analgesics like morphine (used alone
or in combination with other non-opioid analgesics) are likely to remain the "
gold standard" for relief of severe acute pain. However the relatively short
duration of pain relief with opioids means that they require either continuous
infusion or patient-controlled analgesia ("PCA") in which a pump delivers a
series of doses of a short-acting opioid analgesic in response to the patient
pressing a button (under computer control to prevent over-dosing). Both of these
approaches require the patient to have an in-dwelling epidural or intravenous
catheter. Such catheters can fall out or interfere with patient mobility and are
a potential source of infections. Epidural catheters are also contra-indicated
with concomitant use of anticoagulants because of the risk of bleeding in the
spinal column that can potentially result in paralysis. There is a growing trend
toward routine use of anticoagulants in patients undergoing orthopaedic surgery
in order to prevent blood clots.

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 / Mark Court



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