1st Nov 2005 07:00
Skyepharma PLC01 November 2005 For Immediate Release 1 November, 2005 Maruho and SkyePharma Sign Development and Marketing Agreement for Novel Pain Control Agent DepoBupivacaineTM in Japan LONDON, ENGLAND, 1 November, 2005 -- Maruho Company Limited ("Maruho") andSkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announce that they have entered into astrategic agreement for the development, marketing and distribution ofDepoBupivacaineTM in Japan. DepoBupivacaineTM is SkyePharma's novelsustained-release injectable formulation of the local anaesthetic bupivacaineand is designed to provide localised pain relief for more than 48 hours after asurgical operation. Maruho shall pay to SkyePharma up to 18 million dollars including up-front andmilestone payments in consideration of this agreement. Maruho will conduct atits own cost the clinical development of DepoBupivacaineTM required forregulatory approval in Japan. Additionally, SkyePharma will receive a share ofMaruho's sales of this product in Japan, out of which SkyePharma will bear thecost of manufacture. Maruho's president Koichi Takagi said: "Pain is one of Maruho's target strategiccare domains. We believe that DepoBupivacaineTM addresses the disadvantage ofshort-time efficacy of conventional anaesthetics. By using DepoFoamTMtechnology, a single injection at operation sites or affected sites provideslong-term efficacy without the need for continuous epidural injection, which iscomplicated and also whose technique is more difficult, and improves the qualityof life of patients who suffer pain." SkyePharma's Chief Executive Michael Ashton said: "DepoBupivacaineTM is a keypipeline product for SkyePharma. We are delighted to have found in Maruho anexcellent development partner for the important Japanese market. There areapproximately 5 million surgical procedures each year in Japan and the number isgrowing fast because of the ageing population. We and Maruho believe thatDepoBupivacaineTM will bring important advantages to patients undergoingsurgery." DepoBupivacaineTM 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 to recover at home.DepoBupivacaineTM employs SkyePharma's proprietary DepoFoamTM technology andhas been shown in Phase 1 studies to provide local relief of pain for more than48 hours 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. DepoBupivacaineTM is currently in Phase II clinicaldevelopment outside Japan, the results of which are expected to be available bythe end of 2005. In April 2005, SkyePharma announced that it had entered into a development andmarketing agreement with Mundipharma Inc. for all territories outside NorthAmerica and Japan. Endo Pharmaceuticals Inc., SkyePharma's North Americanmarketing partner for DepoDurTM, SkyePharma's first product for relief ofpost-operative pain, has the right of first negotiation for rights toDepoBupivacaineTM in North America, exercisable once SkyePharma has requestedan end of Phase II trial 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 Maruho +81-6-6371-8438Strategy & Licensing Department Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich Notes to Editors About Maruho Maruho, established in Osaka in 1915, is a research-based pharmaceutical companywith a focus on dermatological and orthopaedic products. In 2004 it employedover 800 staff and had revenues of Y37 billion (US$345 million). For furtherinformation, visit www.maruho.co.jp. 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 DepoBupivacaineTM DepoBupivacaineTM is an extended-release injectable formulation of thewidely-used local anaesthetic bupivacaine. Local anaesthetics temporarily blockthe transmission of pain signals along nerve fibres. DepoBupivacaineTM employsSkyePharma's proprietary DepoFoamTM technology to release bupivacaine over aperiod of several days and is supplied as a ready-to-use injectable suspension.DepoBupivacaineTM 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, subarachnoid or intravenous administration. DepoBupivacaineTM 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 DepoBupivacaineTM will also be suitable for useduring surgery on hospital in-patients. 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 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. 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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