DepoMorphine UK Filing

RNS Number:3056S
Skyepharma PLC
20 November 2003


For Immediate Release                                         20 November, 2003




                        SkyePharma Files DepoMorphineTM
                        with European Regulatory Agency


LONDON, ENGLAND, November 20, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announced today that it has submitted an application to the UK Medicines and
Healthcare products Regulatory Agency ("MHRA") for approval of DepoMorphineTM,
SkyePharma's novel sustained-release injectable formulation of morphine for
control of moderate-to-severe post-operative pain. After national approval in
the UK, SkyePharma intends to seek approval in other European countries under
the European Union's Mutual Recognition procedure.

SkyePharma submitted a new drug application ("NDA") for DepoMorphineTM to the
US Food & Drug Administration ("FDA") on 18 July, 2003. Formal acceptance of
this submission was announced on 22 September, 2003, and the NDA is currently
under review by the FDA.

SkyePharma's Chief Executive, Michael Ashton, said: "DepoMorphineTM is
currently our most important pipeline product. We are proud to have achieved our
stated objective of filing the product in both the US and Europe in 2003. We now
look forward to its commercialisation, which we anticipate could commence 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 current approaches to control of post-operative pain leave much
to be desired, suggesting a significant market opportunity for a superior
analgesic."

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 up to 48 hours
following surgery, normally the period of peak post-operative pain. By contrast,
conventional opioid analgesics are relatively short-acting and therefore require
an in-dwelling catheter for repeat or continuous infusion. DepoMorphineTM
avoids the need for an in-dwelling catheter, thereby overcoming a major drawback
to the theoretically desirable 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 more than 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