RNS Number:7544N
Skyepharma PLC
21 July 2003


For Immediate Release                          21 July, 2003


                                 SkyePharma PLC

                      DepoMorphineTM  New Drug Application
                 submitted to the US Food & Drug Administration


LONDON, ENGLAND, July 21, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announced today that on 18 July it submitted a New Drug Application to the US
Food & Drug Administration ("FDA") for DepoMorphineTM, SkyePharma's novel
sustained-release injectable formulation of morphine for control of
moderate-to-severe post-operative pain. DepoMorphineTM  was licensed to Endo
Pharmaceuticals Inc. ("Endo", Nasdaq: ENDP) for North America at the end of
2002. SkyePharma will receive an unspecified milestone payment from Endo on
acceptance of the DepoMorphineTM  submission by the FDA.


SkyePharma's Chief Executive Michael Ashton said, "DepoMorphineTM  is currently
our most important pipeline product. Having taken the decision to undertake full
clinical development ourselves, we are extremely proud to have delivered on our
promise to complete the clinical studies for DepoMorphineTM  and to file it with
the FDA on time. Our clinical trials show that DepoMorphineTM  has great
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 highly effective 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 7 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. In the two Phase III
trials, in hip surgery and lower abdominal surgery, DepoMorphineTM  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 (p