18th Jul 2005 11:30
Skyepharma PLC18 July 2005 For Immediate Release 18 July 2005 SkyePharma PLC ANNUAL GENERAL MEETING STATEMENT LONDON, UK, 18 July 2005 - The Annual General Meeting of SkyePharma PLC (LSE:SKP; NASDAQ: SKYE) was held in London today. All resolutions were passed. Mr Torao Yamamoto, who has now resigned as a Director, was thanked for hiscontribution. Non-Executive Chairman Ian Gowrie-Smith made the following comments toshareholders: "In the past few months we have been able to report no less than eightsignificant events. "I am pleased to report that our partner First Horizon has launched Triglide(TM)on the US market. We and First Horizon believe that Triglide(TM) will have animportant role in this multibillion dollar market. Lipid disorders are verycommon and their association with heart disease is well known. However, eventhose patients who are treated rarely achieve target goals and so there is ampleroom for an effective and easy-to-use treatment such as Triglide(TM). We lookforward to Triglide(TM) becoming one of our most important sources of royaltyincome. "In April, we announced a new agreement with GlaxoSmithKline for Paxil CR(TM). We resolved our differences over the royalty rate we receive with an increase from 3% to 4%, backdated to 2003. Furthermore GlaxoSmithKline generously agreed to maintain our royalty payments even while Paxil CR(TM) was temporarily off themarket because of a manufacturing issue at GlaxoSmithKline's plant in PuertoRico. Such a move pays tribute to the strength of our relationship with ourpartner for this and other products. I am happy to report that Paxil CR(TM)returned to the US market at the end of June and the early prescription datamakes us confident that sales can be rebuilt. "Shareholders will be aware that we have been in negotiations with variouspotential partners to out-license our pulmonary package. We were pleased toannounce in April that we had negotiated Heads of Terms with a major globalpharmaceutical company for Flutiform(TM). This combination treatment for asthmaand COPD is likely to be by far the most important product in the pulmonarypackage with the potential to deliver very significant value to ourshareholders. This is reflected in the negotiated terms, which involve doubledigit royalties and up to $160 million in milestone payments and recovery ofclinical development costs from the beginning of this year. This agreement,which is currently for the US market only, is subject to final contract. Theannouncement of this agreement in April has attracted additional interest inthis product. "DepoDur(TM) is our novel treatment for the relief of pain after surgery. Theproduct was approved by the FDA last year and launched in the US in December byour partner Endo. A hospital product such as DepoDur(TM) takes time to becomeestablished in clinical use and to pass the procedure for acceptance on hospitalformularies. Therefore although sales in the first quarter of 2005 were only afew million dollars, we remain confident in the commercial potential of DepoDur. "In November 2003, the Company submitted the DepoDur(TM) marketing approvalapplication to the UK Medicines and Healthcare Products Approval Agency. We haverecently been informed by the Committee on Safety of Medicines ("CSM") that itwill recommend approval for DepoDur(TM), subject to certain conditions beingsatisfied (these conditions do not include further clinical trials), leading tomarketing authorization in the United Kingdom. The Company is in discussionswith the CSM in respect of these conditions and how they will be satisfied.Assuming the receipt of final approval, the UK approval will be used as thebasis for seeking approval throughout the European Union using the EU's MutualRecognition procedure. "DepoBupivacaine(TM) is another product for the relief of post-operative painbut this time for use primarily after out-patient (or "ambulatory") surgery, nowthe most common type of surgical procedure. We have now licensedDepoBupivacaine(TM) to Mundipharma in Europe. Mundipharma is a private companywhose name may be relatively unfamiliar but it is a hospital specialist and isalready doing an excellent job with DepoCyte(R). In the US we will commencelicensing negotiations once we have the results of our Phase II trial in theautumn. "Finally our partner Novartis has recently obtained approval for Foradil(R)Certihaler(R) in Germany. Although this product is now approved in 13 markets,Germany is the first major market and we are now supplying product to Novartisfor the launch. Foradil(R) Certihaler(R) has "approvable" status in the US andNovartis is working with the FDA to resolve the outstanding issues. Ourdry-powder inhaler and formulation technologies used in Foradil(R)Certihaler(R) are also being used by Novartis in a second collaboration for QAB149 (indacaterol), an even longer-acting bronchodilator that we believe will bean important component of the next generation of asthma treatments." 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 5780Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich Notes for editors: 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 eleven 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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