30th Jun 2006 11:15
Skyepharma PLC30 June 2006 For Immediate Release 30 June 2006 SkyePharma PLC SkyePharma Reacquires European Rights for DepoBupivacaineTM LONDON, UK, 30 June 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcesthat it has completed negotiations with Mundipharma International HoldingsLimited ("Mundipharma") the result of which is that SkyePharma will reacquirethe rights for the marketing and distribution of DepoBupivacaineTM in Europeand other international markets excluding the USA, Canada and Japan. SkyePharmawill also obtain rights to the clinical data from the Phase II trials ofDepoBupivacaineTM. This is expected to simplify the ongoing divestment processof SkyePharma's injectables unit. SkyePharma's Chief Executive Frank Condella said: "DepoBupivacaineTM is themost important near-term product in the injectables pipeline and therefore a keycomponent of the value of this business unit. During our negotiations to divestthis unit we have identified the desirability of clarifying the commercialrights to this key product and we are gratified that we are now in a position tooffer unrestricted global rights to DepoBupivacaineTM (outside Japan) toparties interested in acquiring the injectables unit. Mundipharma remains ourvalued marketing partner for DepoCyte(R) in Europe." Under an agreement announced in April 2005, SkyePharma has received $10 millionto date from Mundipharma, primarily to fund the Phase II clinical trials forDepoBupivacaineTM. SkyePharma will now pay $5 million for the marketing anddistribution rights and for data generated during the Phase II clinicalprogramme. In November 2005 SkyePharma announced that it had entered into an exclusivemarketing and distribution agreement with Maruho Company Limited ("Maruho") forJapan. Maruho is funding the development of the product for approval by theJapanese regulatory agency. 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 / Rebecca Skye Dietrich 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 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. DepoBupivacaineTM has completed Phase II trials and is expected to commence itsPhase III trial programme later this year. 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. 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 ExchangeRelated Shares:
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