20th Jun 2005 07:01
Skyepharma PLC20 June 2005 FOR IMMEDIATE RELEASE 20 June 2005 SkyePharma PLC Foradil(R) Certihaler(TM) Approved in Germany LONDON, UK, 20 June 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcestoday that the German pharmaceutical regulatory authority has approvedFORADIL(R) CERTIHALER(TM) (formoterol fumarate inhalation powder) for thetreatment of asthma and chronic obstructive pulmonary disease ("COPD").FORADIL(R) CERTIHALER(TM) was co-developed by SkyePharma PLC and Novartis PharmaAG. FORADIL(R) CERTIHALER(TM) is a trademark of Novartis. FORADIL(R)CERTIHALER(TM) was submitted for regulatory review in Europe on acountry-by-country basis beginning in December 2002 and has now been approved inSwitzerland, Austria, Finland, Portugal and the Netherlands as well as inGermany. It has also been approved in five countries in Latin America.FORADIL(R) CERTIHALER(TM) was also submitted for regulatory review in the US inDecember 2002. The US Food and Drug Administration (FDA) has assessed theproduct as approvable and Novartis is preparing to provide the agency withadditional data that were requested. The US Foradil(R) franchise has beenlicensed by Novartis to Schering-Plough Corporation. Michael Ashton, SkyePharma's Chief Executive Officer, commented: "The sixthEuropean approval for FORADIL(R) CERTIHALER(TM) is a further milestone in thevalidation of our pulmonary delivery technologies - already recognised by otherunrelated collaborations in the pulmonary area with major pharmaceuticalcompanies such as AstraZeneca and GlaxoSmithKline. We are now manufacturinglaunch material for our partner and look forward to the initiation of commercialsales." FORADIL(R) CERTIHALER(TM) embodies two proprietary SkyePharma technologies, theSKYEHALER(TM), a novel breath-actuated multi-dose dry powder inhaler ("MDDPI")device, and SKYEPROTECT(TM), a powder formulation that protects the drug fromatmospheric moisture to ensure product stability and dose-to-dosereproducibility. Formoterol, the active ingredient in FORADIL(R) CERTIHALER(TM), is a long-actingbeta2-agonist bronchodilator that combines a rapid onset of action (within 5minutes) with a long-lasting bronchodilation effect for 12 hours. This featureoffers important benefits for patients who suffer from asthma and COPD. A majorindependent study published in October 2003 in the European RespiratoryJournal(1) showed that formoterol (delivered by an alternative device) wassuperior to the widely-used short-acting bronchodilator salbutamol in relief ofasthma symptoms under real-life conditions. The breath-actuated FORADIL(R)CERTIHALER(TM) dry-powder inhaler contains 60 doses, giving patients theconvenience of 30 days of therapy in a single inhaler. This evolution of theFORADIL(R) line was developed to provide a valuable and convenient option forasthma and COPD patients who require maintenance therapy with a long-actingbronchodilator. SkyePharma will earn a royalty on future sales of FORADIL(R) CERTIHALER(TM) inall markets. SkyePharma will also manufacture and supply FORADIL(R)CERTIHALER(TM). 1 "Formoterol as relief medication in asthma: a worldwide safety andeffectiveness trial", Pauwels et al., European Respiratory Journal 2003; 22:787-794 For further information please contact: SkyePharma PLC +44 207 491 1777Michael Ashton, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 205 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Notes to Editors 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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