28th Jun 2006 11:32
Skyepharma PLC28 June 2006 For Immediate Release 28 June, 2006 SkyePharma plc ANNUAL GENERAL MEETING STATEMENT LONDON, UK, 28 June 2006 - The Annual General Meeting of SkyePharma plc (LSE:SKP, NASDAQ: SKYE) was held in London today. All resolutions were passed, withthe minimum support level of 99%. Three directors are retiring; Michael Ashton,Sir Michael Beavis and Dr Keith Mansford, have not stood for re-election andwere thanked for their contribution. Non-Executive Chairman Dr Argeris "Jerry" Karabelas made the following commentsto shareholders: "Earlier this year, a strategic review of the company wascompleted. This led to a six-point strategic plan. We were gratified that theExtraordinary General Meeting in March supported this new strategic directionfor the company. 1. Appoint new leadership SkyePharma's founder Ian Gowrie-Smith resigned from the Board in January and Iwas appointed Non-executive Chairman in his place. A new executive managementteam has also been appointed this year with Frank Condella as Chief Executiveand Dr Ken Cunningham as Chief Operating Officer. Both have since joined theBoard. 2. Divest the injectables unit The injectables unit is a stand-alone operation with its own management team andR&D and manufacture in San Diego. SkyePharma's Board has concluded that the unitrequires significant investment in R&D and capital expenditure before it canbecome profitable. Divestment of the injectables unit is expected to bring anumber of benefits, including improving SkyePharma's profitability and reducingthe cash requirements of the ongoing business, and the cash raised by divestmentshould strengthen SkyePharma's balance sheet and permit the Company to explorestrategic options. Furthermore the divestment will allow management to focus onthe core oral/inhalation unit. UBS has been appointed as investment bank forthis disposal and currently a number of interested parties are completing duediligence and are in negotiations. We are working to complete this sale beforethe end of the year. 3. Continue Phase III for FlutiformTM and out-license this year I am pleased to report that FlutiformTM commenced its Phase III trial inFebruary, as planned. We have now completed recruitment for the 12 month safetystudy and the three pivotal studies will commence in the second half, all ontrack for our target of filing with the FDA in the second half of 2007. In May,we announced that we had granted exclusive marketing rights for FlutiformTM inUS (with a right of first negotiation for Canada) to Kos Pharmaceuticals, a USspecialist pharmaceutical company with a highly successful sales record andexperience in the respiratory market. Kos has 750 sales representatives and thisnumber will increase to over 1000 by the time that FlutiformTM is launched. Weare convinced that Kos has an ideal profile to optimise sales of FlutiformTM inthe key US market and we are gratified by their obvious degree of commitment tothe product. This agreement will bring SkyePharma up to $165 million inmilestone payments (including $25 million paid on signature) and a royalty ratethat starts in mid-teens and escalates on sales targets. We will share with Kosthe development of FlutiformTM for asthma and COPD: we will manage and fund thetrials needed for approval of FlutiformTM in adult asthma while Kos will manageand fund the trials needed for all other indications and all marketing andpost-approval studies. We remain in negotiation with other potential partnersfor Europe, Latin America, Japan and other territories. 4. Focus on core oral/inhalation unit and expand pipeline On 21 June SkyePharma held a Business Review day that focused on the core oraland inhalation business, we disclosed two new projects about to enter clinicaltrials: a treatment for pain and inflammation and a novel approach to thetreatment of sleep disorders. We also announced one new partnered project (acontrolled release version of Sular(R) , the lead product of Sciele Pharma (thenew name for First Horizon, our partner for TriglideTM) and reviewed twolate-stage products that had not previously been discussed in detail and whichwill be filed later this year: a controlled release version of the oral asthmadrug Zyflo(R) that we have developed for Critical Therapeutics and LodotraTM, anovel controlled release formulation of an anti-inflammatory drug for rheumatoidarthritis that we have developed for Nitec. We will be seeking additionalcomplementary projects to reinforce our pipeline. 5. Improve operational efficiency Most of SkyePharma's operating cost consists of R&D expenditure. There is littlescope to cut this without prejudicing the Company's future. However we aredetermined to save costs where possible. We have reviewed the rental cost ofour London head office and while this was found to be highly competitive we havedecided to relocate all of the head office staff on a single floor and subletthe rest of space. This will reduce our rental cost by nearly half and alsoavoid the inevitable disruption and cost incurred by moving to new premises. Inthe US we will be vacating our office in New York, which will be sublet. A newsmall office on the East Coast is planned once the injectables divestment hasbeen completed. We have also reviewed overall staffing levels and reduced thenumber of personnel at our plant in Lyon. Concluding remarks I would also like to draw shareholders' attention to certain recentdevelopments. Our injectable product DepoDurTM for post-operative pain wasapproved in the UK in May. This approval will be used as the basis for seekingapproval throughout the European Union. As disclosed in the Annual Report,Foradil(R) CertihalerTM was launched in Germany and Switzerland in September2005 but was recalled from these markets early this year because of concernsthat accidental mishandling of the device had resulted in inaccurate dosing in asmall number of cases. With our partner Novartis we have now completedmodifications to our dry powder inhaler device to prevent mishandling that wehope will allow Foradil(R) CertihalerTM to be returned to the market in Europeand obtain approval in the USA. Finally we have agreed with our US partner EndoPharmaceuticals to terminate development of Propofol IDD-DTM. We believe that the strategic initiatives we have adopted will enable theCompany to maximise the potential of FlutiformTM and other pipeline products, tobecome profitable in the near term and to deliver long-term value forshareholders." For further information please contact: SkyePharma PLC +44 207 491 1777 Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 207 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000 Tim Anderson / Mark Court / Rebecca Skye Dietrich About SkyePharma SkyePharma develops pharmaceutical products benefiting from world-leading drugdelivery technologies that provide easier-to-use and more effective drugformulations. There are now ten 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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