SKP.L Regulatory News (SKP)

18 Jul 2005 07:00

Skyepharma PLC18 July 2005 FOR IMMEDIATE RELEASE 18 July, 2005 SkyePharma PLC Triglide(TM) Launched on US Market Addresses Major Market Opportunity in the Treatment of Lipid Disorders LONDON, ENGLAND, 18 July, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)announces that its partner First Horizon Pharmaceutical Corporation ("FirstHorizon") has launched Triglide(TM) (fenofibrate) and the product is nowavailable in pharmacies in the United States. Triglide(TM) is a once-daily oraltreatment for lipid disorders such as elevated cholesterol and triglycerides.Fenofibrate not only lowers levels of total triglycerides and LDL cholesterol ("bad cholesterol") in the bloodstream but also has the valuable property ofraising abnormally low levels of HDL cholesterol ("good cholesterol"), which isincreasingly recognized as a major cardiovascular risk factor. SkyePharmareceived FDA approval for Triglide(TM) on 7 May 2005. Michael Ashton, SkyePharma's Chief Executive Officer, said: "Elevatedcholesterol already affects over half of the US population and treatmentrepresents a major area of unmet medical need. Triglide(TM), our new formulationof fenofibrate, overcomes a major drawback of an otherwise valuable medicationand fenofibrate is more effective than statins in boosting HDL levels. We see asubstantial opportunity for Triglide(TM). First Horizon's 400-strong representative force focuses on cardiovascularphysicians and high-prescribing primary care practitioners and has a provenability to capture market share in the cardiovascular therapeutic area." Fenofibrate is highly insoluble in water, resulting in variable uptake from thestomach and requiring the patient to take the tablets with food. Triglide(TM),the new formulation of fenofibrate developed by SkyePharma, has a comparableabsorption under fed and fasting conditions and therefore allows patients totake the drug at any time, improving compliance and simplicity for both patientsand prescribers. Triglide(TM) is the first approved product utilizingSkyePharma's proprietary IDD(R)-P solubilization technology. In May 2004, SkyePharma announced that it had granted First Horizon exclusiveU.S. marketing and distribution rights for Triglide(TM). Under this agreement,SkyePharma will receive up to $50 million in milestone payments, $30 million ofwhich are sales-based milestone payments. SkyePharma received a payment of $5million upon signature of the agreement and a further $15 million on FDAapproval in May 2005. In addition SkyePharma will receive a royalty of 25% ofFirst Horizon's net sales of the product. SkyePharma will manufacture and supplythe product from its Lyon manufacturing facility. SkyePharma will also make acontribution of up to $5 million to First Horizon's initial marketing expensesto establish the product. For further information please contact: SkyePharma PLC +44 207 491 1777 Michael Ashton, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 205 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court/ Rebecca Skye Dietrich Notes to 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. About lipid disorders Lipid disorders are a group of conditions associated with excessive levels oflipids (fatty substances) in the bloodstream. Hyperpidaemia (elevated bloodlipids) is an important risk factor in the development of atherosclerosis andheart disease. The major lipids in the blood are triglycerides and cholesterol, either free orin the form of lipoproteins, molecules of fat or cholesterol linked to protein.Types of lipoproteins include very low-density lipoproteins (VLDL), low-densitylipoproteins (LDL), and intermediate-density lipoproteins (IDL). High-densitylipoproteins (HDL), or "good cholesterol," actually reduce the risk of heartdisease and are therefore protective factors. The treatment guidelines for hyperlipidaemia of the US National Institutes ofHealth aim to reduce the incidence of heart disease. The current guidelines arethat LDL levels should be below 100 mg/dl and total cholesterol below 200 mg/dland HDL levels should be above 40 mg/dl. Although these guidelines are widelyaccepted, it is estimated that over half of the American population have totalcholesterol above 200 mg/dl. Of these, less than half are currently treated andof the treated group less than one third achieve the target goals. The principal drug treatments for hyperlipidaemia are "statins" (HMG-CoAreductase inhibitors that block endogenous synthesis of cholesterol in theliver) and fibrates (PPAR-a agonists that increase the metabolic elimination oflipoproteins). References: Amer J Cardiol 2003:92:79- 81, 2001:88:265-269; Europ Heart J 2001:22:554-772; Current-Medical-Research-and-Opinion 2004:20:1025-1033 About fenofibrate Fenofibrate, an oral fibrate lipid lowering agent, was developed by GroupeFournier and first introduced internationally in 1975. In the US it was licensedto Abbott Laboratories, which launched it in 1996 as Tricor(R). Abbott's salesof Tricor(R) in 2004 were US$ 778 million (a year-on-year increase of 38%).Fenofibrate markedly reduces elevated plasma concentrations of triglycerides. Italso decreases elevated plasma concentrations of LDL and total cholesterol. Atthe same time, fenofibrate increases abnormally low levels of HDL cholesterol.The latter property is particularly important as there is growing recognitionthat abnormally low levels of HDL cholesterol may represent a more importantrisk factor for cardiovascular disease then elevated LDL levels. Althoughstatins are the most potent agents for lowering LDL levels, statins are onlymodestly effective in raising HDL cholesterol levels. The mode of action offenofibrate is different from that of the statins and the two actsynergistically, with a significantly greater effect on lipid levels when usedtogether than when each is used individually. Both the current American DiabetesAssociation and NICE guidelines recommend the appropriate use of fenofibrate incombination with statins. Fenofibrate is a prodrug of the active agent, fibric acid, and is virtuallyinsoluble in water. Uptake from the stomach under fasting conditions is highlyvariable but uptake is substantially enhanced by food, especially by dietaryfat. About SkyePharma's IDD(R)-P technology SkyePharma has a family of proprietary technologies designed to overcome theinsolubility of many drug substances in water, which adversely affectsbioavailability. SkyePharma's Insoluble Drug Delivery-MicroParticle (IDD(R)-P)technology involves preparing microparticles of active drug and then stabilizingthese with phospholipid surface modifying agents that prevent the microparticlesfrom reaggregating. Triglide(TM) tablets incorporate a novel fenofibrateformulation developed to optimize bioavailability independent of food. In thisformulation, fenofibrate crystals have been reduced to sub-micron to micron sizeparticles, stabilized by phospholipid (lecithin) surface modifiers The tabletsare designed to protect and rapidly release the fenofibrate microparticles. Thisexpands the surface area of drug exposed to the dissolution medium and therebyincreases bioavailability. 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 Exchange