Innovative Single Epidural Injection 48 Hours of Post-Surgical Pain Relief LONDON, April 28 /PRNewswire-FirstCall/ -- SkyePharma PLC (LSE:SKPLSE:Nasdaq:LSE:SKYE)) announces today that the UK Medicines and Healthcare products Regulatory Agency ("MHRA") has approved SkyePharma's DepoDur(TM) for the treatment of pain following major surgery. Previously referred to as DepoMorphine(TM), DepoDur(TM) is a novel single dose sustained-release injectable formulation of morphine. Frank Condella, Chief Executive of SkyePharma, said: "We are delighted with the approval of DepoDur(TM) in the UK and are confident that this will lead to additional approvals in other European markets under the Mutual Recognition Process DepoDur(TM) represents another successful outcome resulting from the major commitment SkyePharma has made to product development, including funding the product through Phase III trials and building and on-going funding of a purpose-built manufacturing plant in San Diego, USA. Our clinical trial programme for DepoDur(TM) involved over 1000 patients in four different pain models and demonstrated the great potential of the product to improve the control of post-operative pain. "DepoDur(TM) was developed and is manufactured by SkyePharma Inc. the San Diego based injectable business, which SkyePharma has announced is in the process of being divested, "This approval, along with the availability of EU rights for DepoDur(TM), provides further value to our injectable business." DepoDur(TM) was licensed to Zeneus for distribution in the EU. Recently, SkyePharma bought back the rights to the product. DepoDur(TM) is licensed to Endo Pharmaceuticals for sale in the USA. For further information please contact: SkyePharma PLC +44 207 491 1777 Frank Condella, Chief Executive Officer Peter Laing, Director of Corporate Communications +44 207 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000 Tim Anderson/Rebecca Skye Dietrich About SkyePharma 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 twelve approved products incorporating SkyePharma's 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 DepoDur(TM) DepoDur(TM) is a single dose extended-release injectable formulation of morphine sulphate. DepoDur(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 up to 48 hours following surgery. There is no need for an in-dwelling catheter for continuous infusion, thereby overcoming a major drawback to the otherwise theoretically desirable epidural route of administration for opioid analgesics. DepoDur(TM) is designed for the control of pain after major surgery. SkyePharma expects that its main use will be in control of post-operative pain in hospitalised patients undergoing major surgical procedures requiring general or regional 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. DepoDur(TM) is supplied in a 2 ml vial containing a 10 mg/ml suspension in sterile saline and is administered as a single dose epidural injection at the lumbar level prior to surgery (or after clamping of the umbilical cord during caesarean section). The recommended dose is 10 mg for caesarean section, 10-15 mg for lower abdominal surgery and 15 mg for major orthopaedic surgery of the lower extremities. Some patients may benefit from a dose of 20 mg. It should be appreciated that as with all opioids the incidence of serious adverse respiratory events is dose-related. Respiratory depression is the chief hazard of all opioid preparations and occurs more frequently in elderly or debilitated patients. For elderly patients (age >65 years), the low end of the dosing range for DepoDur(TM) is recommended together with vigilant peri- operative monitoring. On 20 November 2003 SkyePharma submitted an application for DepoDur(TM) to the UK Medicines and Healthcare products Regulatory Agency ("MHRA"). Following national approval in the UK, SkyePharma now intends to seek approval in other European Union countries under the Mutual Recognition procedure. SkyePharma has licensed DepoDur(TM) to Endo for North America and is now seeking a partner for the product in the EU. SkyePharma has completed seven clinical trials of DepoDur(TM). The Phase IIb and Phase III clinical development programme for DepoDur(TM) involved four separate pain models and included more than 1000 patients. In the two Phase III trials, in hip surgery and lower abdominal surgery, DepoDur(TM) demonstrated extended 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