19th Apr 2005 15:31
Skyepharma PLC19 April 2005 For Immediate Release 19 April, 2005 SkyePharma PLC $80 million European Development and Marketing Agreement for Novel Pain Control Agent DepoBupivacaine(TM) LONDON, ENGLAND, 19 April, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)announces that it has entered into a strategic development and marketingarrangement with Mundipharma International Holdings Limited ("Mundipharma") forthe marketing and distribution of DepoBupivacaine(TM) in Europe and otherinternational markets excluding the USA, Canada and Japan. Mundipharma isalready SkyePharma's European marketing partner for the cancer treatmentDepoCyte(R). Under the agreement with Mundipharma, SkyePharma will receive $10 million onsignature, most of which will be deferred and recognised to income to cover thecost of the Phase II clinical trials. SkyePharma will also receive furthercontributions of up to US$20 million towards the cost of the Phase III clinicaltrials required to gain approvals, and additional milestone payments onattainment of development milestones, marketing approvals and sales targets. Ifall targets are met total payments will amount to over US$80 million. SkyePharmawill be responsible for clinical development. SkyePharma will also receive a 35%share of Mundipharma's sales of DepoBupivacaine(TM) in Europe (30% in otherterritories), out of which SkyePharma will bear the cost of manufacture. SkyePharma's Chief Executive Michael Ashton said: "DepoBupivacaine(TM) is one ofthe most important products in our pipeline. With the possibility of providingextended localised pain relief for up to 4 days, DepoBupivacaine(TM) shouldbecome the analgesic of choice for the increasing number of day surgeries. Thistype of surgery has already overtaken hospital inpatient operations to becomethe most common surgical procedure and is the fastest growing part of themarket. We are delighted to extend our relationship with Mundipharma, which iscurrently successfully marketing another of our products, DepoCyte(R), inEurope. This deal structure not only continues our recent trend towards a larger royaltyshare but also relieves our income statement of the considerable cost ofResearch and Development." DepoBupivacaine(TM) is SkyePharma's novel sustained-release injectableformulation of the local anaesthetic bupivacaine, currently widely used as alocal or regional anaesthetic during surgery, either in a hospital in-patientsetting or in ambulatory (or "day") surgery in which the patient is dischargedfrom the hospital or clinic shortly after surgery and recovers at home.DepoBupivacaine(TM) employs SkyePharma's proprietary DepoFoam(TM) technology andhas been shown in Phase 1 studies to provide local relief of pain for up to 96hours after a single injection instead of 8-12 hours for conventionalimmediate-release bupivacaine. Superior control of pain after discharge isexpected to reduce the need for other analgesics and to improve patient recoveryand rehabilitation. DepoBupivacaine(TM) is currently in Phase II clinicaldevelopment. Endo Pharmaceuticals Inc., SkyePharma's North American marketingpartner for DepoDur(TM), SkyePharma's other product for relief of post-operativepain, has the right of first negotiation for rights to DepoBupivacaine(TM) inNorth America, exercisable once SkyePharma has requested an end of Phase IItrial meeting with the US Food & Drug Administration. For further information please contact: SkyePharma PLC +44 207 491 1777Michael Ashton, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 207 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 MundipharmaRob Cohen, European Communications Director +44 1223 424211 +44 7734 159122 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Notes to Editors About SkyePharma SkyePharma PLC uses its world-leading drug delivery technology to developeasier-to-use and more effective formulations of drugs. The majority ofchallenges faced in the formulation and delivery of drugs can be addressed byone of the Company's proprietary technologies in the areas of oral, injectable,inhaled and topical delivery, supported by advanced solubilisation capabilities.For more information, visit www.skyepharma.com. About Mundipharma Mundipharma is one of the Purdue/Mundipharma/Napp independent associatedcompanies, privately owned companies and joint ventures that cover the world'spharmaceutical markets. The companies have particular expertise in bringing topatients the benefits of novel drug delivery systems such as those used toenhance medicines for the relief of severe pain. For further information, visitwww.mundipharma.co.uk. About DepoBupivacaine(TM) DepoBupivacaine(TM) is an extended-release injectable formulation of the localanaesthetic bupivacaine. Local anaesthetics temporarily block the transmissionof pain signals along nerve fibres. DepoBupivacaine(TM) employs SkyePharma'sproprietary DepoFoam(TM) technology to release bupivacaine over a period ofseveral days and is supplied as a ready-to-use injectable suspension.DepoBupivacaine is designed for administration by local infiltration at woundsites, as a peripheral nerve block or by the lumbar epidural route. It is notsuitable for intrathecal or intravenous administration. DepoBupivacaine(TM) is designed for the prolonged control of pain after surgery.SkyePharma expects that its main use will be in control of post-operative painin patients who have undergone ambulatory surgical procedures under local orregional anaesthesia. However DepoBupivacaine(TM) will also be suitable for use in surgery on hospital in-patients. About DepoFoam(TM) DepoFoam(TM) is SkyePharma's proprietary sustained-release injectable deliverytechnology. This is fully commercialised and approved by regulatory agencies inboth the USA and Europe. DepoFoam(TM) consists of lipid-based particlescontaining 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 phospholipids 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 post-operative pain after ambulatory surgery Ambulatory surgery (also known as "day" surgery) is normally performed inhospital out-patient facilities, free-standing ambulatory surgery centres or inphysicians' offices. In contrast with a major surgical operation on a hospitalin-patient, which routinely involves general anaesthesia followed by severaldays of recovery in the hospital, ambulatory surgery is normally conducted undera local or regional anaesthetic, and a few hours after the procedure the patientis discharged to recover at home. The development of less invasive surgicalprocedures and the drive to reduce the high costs of hospitalisation has led toa rapid growth in ambulatory surgery, which now accounts for about 65% ofelective surgical procedures in the USA (against 16% in 1980). Today more than30 million patients undergo surgical procedures on an ambulatory basis each yearin the United States. Typical ambulatory procedures include tonsillectomies,hernia repairs, gall bladder removals, colonoscopies, some cosmetic surgeries,and cataract surgeries. Currently oral analgesics are the principal approach to control of pain afterthe anaesthetic used in ambulatory surgery wears off. Patients discharged fromhospital after ambulatory surgery to recover at home are not under full-timemedical supervision, which restricts both the type and quantity of analgesicsthat can be used. For example, the highly effective opioid analgesics arelargely precluded in the home setting because of the accompanying risks ofnausea and vomiting and respiratory depression. Patients are therefore oftensubject to inadequate pain relief during the immediate post-surgical period,which not only is undesirable but also can delay recovery. Recent surveysindicate that after ambulatory surgery up to 40% of outpatients suffered frommoderate to severe pain during the first 24-48 hours after discharge. Moreinvasive, and therefore more painful, surgical procedures (such as kneereconstruction) are increasingly being performed on an ambulatory basis,reinforcing the need for more effective ways of controlling post-operative pain. Except for the historical information herein, the matters discussed in this newsrelease include forward-looking statements that may involve a number of risksand uncertainties. Actual results may vary significantly based upon a number offactors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. These include without limitation risks in obtaining andmaintaining regulatory approval for existing, new or expanded indications forits products, other regulatory risks, risks relating to SkyePharma's ability tomanufacture pharmaceutical products on a large scale, risks that customerinventory will be greater than previously thought, risks concerning SkyePharma'sability to manage growth, SkyePharma's marketing partners' ability to market apharmaceutical product on a large scale and manage their sales and marketingorganisation and maintain or expand sales and market share for its products,risks relating to the ability to ensure regulatory compliance, risks related tothe research, development and regulatory approval of new pharmaceuticalproducts, risks related to research and development costs and capabilities,market acceptance of and continuing demand for SkyePharma's products and theimpact of increased competition, risks associated with anticipated top andbottom line growth and the possibility that upside potential will not beachieved, competitive products and pricing, and risks associated with theownership and use of intellectual property rights. SkyePharma undertakes noobligation to revise or update any such forward-looking statement to reflectevents or circumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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