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New Drug Application for DepoMorphine Accepted for Filing by FDA

LONDON, Sept. 23 /PRNewswire-FirstCall/ -- SkyePharma PLC (NASDAQ:SKYE) announced today that on 16 September the US Food & Drug Administration ("FDA") formally accepted for filing a New Drug Application ("NDA") for DepoMorphine(TM), 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. DepoMorphine(TM) 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 DepoMorphine(TM) submission triggers a US$5 million milestone payment from Endo to SkyePharma.

SkyePharma's Chief Executive Michael Ashton said, "DepoMorphine(TM) 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 DepoMorphine(TM) 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."

DepoMorphine(TM) employs SkyePharma's proprietary DepoFoam(TM) 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.

DepoMorphine(TM) 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 DepoMorphine(TM). The Phase IIb and Phase III clinical development programme for DepoMorphine(TM) involved four separate pain models and included nearly 1000 patients.

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

Source: SkyePharma PLC

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