22nd May 2006 07:00
Skyepharma PLC22 May 2006 For Immediate Release 22 May 2006 SkyePharma PLC SkyePharma to Develop Improved Controlled Release Version of Sular for First Horizon LONDON, UK, 22 May 2006 - SkyePharma PLC (LSE: SKP; Nasdaq: SKYE) announces thatit has entered into an agreement with First Horizon Pharmaceutical Corporation("First Horizon", Nasdaq: FHRX) to develop a novel controlled-release version ofSular (nisoldipine), an antihypertensive that is First Horizon's largestproduct. First Horizon's cardiovascular and metabolic product portfolio salesamounted to $145 million in 2005. The SkyePharma version is designed to have animproved pharmacokinetic profile and is expected to replace the current versionand to expand the market opportunity for Sular. Frank Condella, SkyePharma's Chief Executive Officer, said: "SkyePharma's corecompetency is the development of improved formulations of existing products.This new agreement reinforces our activities in this area now that we arefocusing on our core business of oral and inhalation products. We are alsopleased to expand our collaboration with First Horizon, a fast growing USpharmaceutical company." SkyePharma will receive a mid-single digit royalty on net sales of Sular CR.SkyePharma will also receive a total of up to $5 million in milestone payments.$1 million has been paid at signing and up to $4 million will be paidconditional on obtaining approval by the US Food & Drug Administration ("FDA"),which is expected in 2008. SkyePharma may manufacture and supply the productfrom its Lyon manufacturing facility. First Horizon will fund all ofSkyePharma's development costs for Sular CR and will market this product throughits speciality sales force (currently 525 representatives of whom 450 arefocused on primary care physicians). Nisoldipine, the active ingredient in Sular, is an antihypertensive agent usedto reduce blood pressure. It is estimated that 65 million Americans (nearly onequarter of the population) currently have elevated blood pressure, a recognisedrisk factor for stroke and heart attacks, and this number is increasing fromdemographic factors as the post-war "Baby Boom" reaches middle age. 60% of thoseaffected are diagnosed and receive treatment but only half of those treatedattain treatment goals so there is a recognised opportunity for bettertreatments. Nisoldipine is a calcium channel blocker that prevents calcium fromentering certain types of muscle cells. Because muscle cells need calcium tocontract, calcium channel blockers prevent the cells from contracting and causethem to relax. Nisoldipine selectively relaxes the muscles of small arteriescausing them to dilate but has little or no effect on muscles or the veins ofthe heart. For further information please contact: SkyePharma PLC Frank Condella, Chief Executive +44 207 491 1777Peter Laing, Director of Corporate Communications +44 207 491 5124 Sandra 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 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 First Horizon First Horizon is a leading US specialty pharmaceutical company that acquires,develops and markets prescription medicines within its chosen therapeutic areasof cardiovascular, obstetrical and gynaecological, paediatric andgastroenterological conditions and disorders. Since 1992, First Horizon hasintroduced 17 products. First Horizon promotes its products through itsnationwide sales and marketing force of more than 500 professionals. For moreinformation, visit www.horizonpharm.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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