28th Apr 2006 07:02
Skyepharma PLC28 April 2006 For Immediate Release 28 April, 2006 SkyePharma PLC SKYEPHARMA ANNOUNCEs first European APPROVAL OF DEPODUR(TM) Innovative Single Epidural Injection 48 Hours of Post-Surgical Pain Relief LONDON, UK, 28 April 2006 -- SkyePharma PLC (LSE: SKP, Nasdaq: SKYE)) announcestoday that the UK Medicines and Healthcare products Regulatory Agency ("MHRA")has approved SkyePharma's DepoDur(TM) for the treatment of pain following majorsurgery. Previously referred to as DepoMorphine(TM), DepoDur(TM) is a novelsingle dose sustained-release injectable formulation of morphine. Frank Condella, Chief Executive of SkyePharma, said: "We are delighted with theapproval of DepoDur in the UK and are confident that this will lead toadditional approvals in other European markets under the Mutual RecognitionProcess DepoDur(TM) represents another successful outcome resulting from themajor commitment SkyePharma has made to product development, including fundingthe product through Phase III trials and building and on-going funding of apurpose-built manufacturing plant in San Diego, USA. Our clinical trialprogramme for DepoDur(TM) involved over 1000 patients in four different painmodels and demonstrated the great potential of the product to improve thecontrol of post-operative pain. "DepoDur(TM) was developed and is manufactured by SkyePharma Inc. the San Diegobased injectable business, which SkyePharma has announced is in the process ofbeing divested, "This approval, along with the availability of EU rights forDepoDur(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 (Nasdaq: ENDP) for sale in theUSA. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 207 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson/Rebecca Skye Dietrich Notes for editors: About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now twelve approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. About DepoDur(TM) DepoDur(TM) is a single dose extended-release injectable formulation of morphinesulphate. DepoDur(TM) employs SkyePharma's proprietary DepoFoam(TM) technology and is supplied as a ready-to-use suspension. It is given as a single epiduralinjection before or during surgery and provides pain relief for up to 48 hoursfollowing surgery. There is no need for an in-dwelling catheter for continuousinfusion, thereby overcoming a major drawback to the otherwise theoreticallydesirable epidural route of administration for opioid analgesics. DepoDur(TM) is designed for the control of pain after major surgery. SkyePharmaexpects that its main use will be in control of post-operative pain inhospitalised patients undergoing major surgical procedures requiring general orregional anaesthesia such as major abdominal surgery, orthopaedic surgery andcaesarean section. Currently there are an estimated 6 million such proceduresevery year in the USA and 5 million in Europe. DepoDur(TM) is supplied in a 2 ml vial containing a 10 mg/ml suspension insterile saline and is administered as a single dose epidural injection at thelumbar level prior to surgery (or after clamping of the umbilical cord duringcaesarean section). The recommended dose is 10 mg for caesarean section, 10-15mg for lower abdominal surgery and 15 mg for major orthopaedic surgery of thelower extremities. Some patients may benefit from a dose of 20 mg. It should beappreciated that as with all opioids the incidence of serious adverserespiratory events is dose-related. Respiratory depression is the chief hazardof all opioid preparations and occurs more frequently in elderly or debilitatedpatients. For elderly patients (age >65 years), the low end of the dosing rangefor 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 andPhase III clinical development programme for DepoDur(TM) involved four separatepain models and included more than 1000 patients. In the two Phase III trials,in hip surgery and lower abdominal surgery, DepoDur(TM) demonstrated extendeddose-related analgesia and achieved its primary endpoint (superiority over studycomparators in terms of total demand for opioid analgesics after surgery) with ahigh degree of statistical significance (pRelated Shares:
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