21st Jun 2006 07:01
Skyepharma PLC21 June 2006 For Immediate Release 21 June 2006 SkyePharma Business Review Day 2006 LONDON, UK, 21 June 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcestoday that it is holding a Business Review meeting. This meeting (which is beingwebcast on SkyePharma's website live at 09.30 a.m. (BST) www.skyepharma.com) istaking place at the offices of Buchanan Communications (45 Moorfields LondonEC2). Frank Condella, SkyePharma's Chief Executive, said: "I welcome the opportunityto review our expanding portfolio of marketed products, our near-term andearly-stage pipeline of products that we have developed for subsequentout-licensing and also our family of delivery technologies. With our Injectablesbusiness unit scheduled for divestment, this will provide an excellentopportunity for investors to learn more about our core business of oral andinhalation products." Frank Condella is providing the Introduction on SkyePharma's strategy. Aspreviously announced, SkyePharma has decided to concentrate on oral andinhalation products and to divest its injectable business interests. Theproposed divestment is expected not only to release cash but also to relieve theCompany of a significant cash burn and future capital expenditure. The residualcore business is also expected be able to achieve profitability in the nearterm. Furthermore, with greater focused resources the Company expects to be in abetter position to further develop its pipeline of oral and inhalation products.Ultimately, it is the Company's strategy to add a niche sales and marketingcapability in one or more markets that would improve profit growth and give itgreater control over revenue generation. This section contains information onthe Injectables business that is being divested, including clinical and marketpotential data on DepoBupivacaineTM, SkyePharma's novel sustained-releaseinjectable formulation of the local anaesthetic bupivacaine for control ofpost-operative pain. DepoBupivacaineTM has completed Phase II trials and isexpected to commence its Phase III trial programme later this year. Frank isalso reviewing the portfolio of sustained-release injectable formulations ofprotein and peptide drugs. Dr Werner Enz, SkyePharma's Vice-President - Commercial, is reviewingSkyePharma's currently marketed products. These include Paxil CRTM, SkyePharma'simproved formulation of GlaxoSmithKline's antidepressant Paxil(R) (paroxetine);Xatral(R) OD (Uroxatral(R) in the USA), a once-daily version of Sanofi-Aventis'sXatral(R) (alfuzosin), a treatment for the urinary symptoms of benign prostatichypertrophy; and Solaraze(R), SkyePharma's topical gel treatment for actinickeratosis, now marketed in the US by the Doak Dermatologics unit of BradleyPharmaceuticals and in Europe and certain other territories by ShirePharmaceuticals. Dr Enz is accompanied by Patrick Fourteau, Chief Executive ofSciele Pharma, Inc, (the new name for First Horizon Pharmaceutical Corporation),who is presenting information on TriglideTM, SkyePharma's novel formulation offenofibrate for the treatment of lipid disorders, which is marketed in the US bySciele. Mr Fourteau is also presenting on the controlled release formulationthat SkyePharma is developing for Sciele of its lead product Sular(R)(nisoldipine), which is expected to reach the market in 2008. Dr Francesco Patalano, Managing Director of SkyePharma AG, is reviewingSkyePharma's near-term and pre-approval pipeline. This includes Pulmicort(R)HFA-MDI, a non-CFC aerosol inhaler containing the inhaled steroid budesonide forasthma, developed for AstraZeneca and approved in its first market in Europeearlier this year; Requip Once-a-day, a new controlled release oral formulationof Requip(R), GlaxoSmithKline's treatment for Parkinson's disease, filed at theend of 2005; a new controlled release formulation of Zyflo(R) (zileuton),Critical Therapeutics' oral treatment for severe asthma, due to be filedshortly; and Nitec's LodotraTM, a novel approach to the treatment of rheumatoidarthritis that uses SkyePharma's GeoClockTM technology to deliver the activeingredient at the most appropriate time of day. This product, previouslyundisclosed, has recently completed Phase III and is expected to be filed laterthis year. Dr Geraldine Venthoye, the head of SkyePharma's Inhalation Business Unit, isreviewing Foradil(R) CertihalerTM, a new version of Novartis bronchodilatorForadil(R) based on SkyePharma's novel multi-dose dry-powder inhaler, theSkyeHalerTM. Foradil(R) CertihalerTM has now been approved in more than 20countries and has an "approvable" letter from the FDA. The product was launchedin Germany and Switzerland in September 2005 but a recall from these markets wasinitiated in January 2006 because of concerns that accidental mishandling of thedevice had resulted in inaccurate dosing in a small number of cases. SkyePharmais collaborating with Novartis and the relevant health authorities toinvestigate the reasons and the actions necessary before the product can bereturned to the market. In the US, the FDA issued an "approvable" letter forForadil(R) CertihalerTM in April 2006 but the FDA is requiring devicemodification as a prerequisite for approval. Dr Ken Cunningham, Chief Operating Officer, is reviewing FlutiformTM, afixed-dose combination of the long-acting bronchodilator formoterol and theinhaled steroid fluticasone in a metered-dose aerosol inhaler (MDI) using ahydrofluoroalkane (HFA) propellant. This is expected to be the third entrant tothe fast-growing US market for combination treatments for asthma and COPD. ThePhase III trial of FlutiformTM, started in February 2006, is on track for thetarget of filing in the second half of 2007 and US market entry in early 2009.Dr Cunningham's review includes a video interview with Professor Peter Barnes,one of the leading authorities in the field of respiratory disease, and acontribution from Adrian Adams, the President and Chief Executive of KosPharmaceuticals, recently appointed as SkyePharma's US licensee and developmentpartner for FlutiformTM. Dr Guy Vergnault, head of SkyePharma's Oral Delivery Business Unit, and DrVenthoye are reviewing SkyePharma's oral and inhalation delivery technologies.Dr Vergnault is focussing on the GeoClockTM and solubilisation technologies andDr Venthoye on SkyePharma's family of inhalation devices and associatedformulation technologies. Dr Cunningham is reviewing the early-stage pipeline. This includes twopreviously undisclosed oral products: SKLP-132, a fixed-dose combination of anopioid analgesic and a non-steroidal anti-inflammatory for moderate to severepain; and SKP-1041, a non-benzodiazepine hypnotic in a novel deliveryformulation for the maintenance of sleep. Both of these products addresssubstantial market opportunities. 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. 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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