SKP.L Regulatory News (SKP)

31 May 2006 09:08

Skyepharma PLC31 May 2006 For Immediate Release 31 May 2006 SkyePharma PLC PAPERS ON DEPOCYT(R) TO BE PRESENTED AT ASCO LONDON, UK, 31 May 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcestoday that at the forthcoming 2006 Annual Meeting of the American Society ofClinical Oncology ("ASCO"), which is being held in Atlanta, Georgia on June 2-6,two papers will be presented on DepoCyt(R), SkyePharma's treatment forneoplastic meningitis. William R Shapiro, MD from St Joseph's Hospital and Medical Center, Phoenix,Arizona, will present "A randomized phase III/IV study to determine benefit andsafety of cytarabine liposome injection for treatment of neoplastic meningitis."Michael J Glantz, MD from the Oncology Department of the University ofMassachusetts, Worcester, Massachusetts, will present "Interaction between routeof intra-CSF chemotherapy administration and efficacy of therapy in patientswith neoplastic meningitis" DepoCyt(R) is a sustained release injectable formulation of cytarabine and isapproved in both the USA and Europe for the treatment of lymphomatousmeningitis, a serious late-stage complication of lymphoma, a form of canceraffecting the lymphatic system. Lymphomatous meningitis is a subset ofneoplastic meningitis (see explanation below). Cytarabine is known to be aneffective treatment for neoplastic meningitis but it is rapidly metabolised.Patients therefore require spinal (intrathecal) injections at least twice a week- these are uncomfortable for the patient and carry significant risks includingthe introduction of infection. SkyePharma's proprietary DepoFoamTM deliverytechnology encapsulates cytarabine in a water-based solution within minuteparticles of lipid. After injection, these particles gradually degrade,prolonging the release of the drug and extending the period between injectionsto two weeks. This brings much less disruption to the life of the patient,reduces the associated risks accompanying frequent injections and also bringssavings in hospital costs with the reduced admission rate. Sustained maintenanceof high levels of cytarabine in the cerebrospinal fluid may also prolong thetime to neurological progression. Lymphomatous meningitis is a comparatively uncommon condition with approximately10,000 cases reported worldwide each year. Consequently DepoCyt(R) has beengranted "Orphan Drug" status in the USA. SkyePharma has conducted a Phase IVstudy in patients with lymphomatous meningitis and solid tumour neoplasticmeningitis. DepoCyt(R) was approved by the US Food & Drug Administration in April 1999 andis marketed in North America by Enzon Pharmaceuticals. Rights in Japan werelicensed to Nippon-Shinyaku in 2001 although the product is not yet on themarket. DepoCyt(R) is licensed to Mundipharma for Europe (which markets it asDepoCyte). DepoCyte(R) was approved by the European Medicines EvaluationAuthority in August 2001. 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 / Mark Court Notes for editors: About neoplastic meningitis In many forms of cancer, secondary tumours (metastases) form in the meninges,the membrane that surrounds the brain and spinal cord. From autopsy data,neoplastic meningitis affects up to 20% of all cancer patients (Posner,Neurological Complications of Cancer, 1995) but the condition is only diagnosedin 4-7% of cancer patients. The symptoms are pain and progressive deteriorationof neurological function and few patients survive more than a few months, withdeath either from neurological dysfunction or from the primary tumour. The goalof therapy for neoplastic meningitis is palliation, not cure. The principaltreatments are normally radiotherapy and chemotherapy to clear the cerebrospinalfluid of malignant cells and to prevent or slow recurrence. Most cytotoxic drugsdo not cross the blood-brain barrier so the main chemotherapy treatments aremethotrexate or cytarabine, injected intrathecally. These drugs reduce pain andslow degradation of neurological function but have the disadvantage of rapidclearance from the circulation and so require frequent injections. About DepoFoamTM DepoFoamTM is SkyePharma's proprietary sustained release injectable deliverytechnology. This is fully commercialised and approved by regulatory agencies inboth the USA and Europe. DepoFoamTM consists of tiny lipid-based particleswhich contain discrete water-filled chambers dispersed through the lipid matrix.The particles are 10-30 microns in diameter and are suspended in saline. Thesuspension resembles skimmed milk and can be injected through a fine needle. Thewater-filled chambers containing active drug account for most of the weight ofthe particles. The lipids are naturally occurring substances (or closeanalogues) such as lecithin and triglycerides. The small amount of lipid iscleared rapidly in the body as the particles deliver their drug payload over aperiod that can be modified from 1 to 30 days. For example in DepoCyt(R)/DepoCyte(R) the circulating half-life of the drug cytarabine is increased from3.4 hours to 141 hours. 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. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances after the date of this release. This information is provided by RNS The company news service from the London Stock Exchange