28th Jun 2005 14:47
Skyepharma PLC28 June 2005 FOR IMMEDIATE RELEASE 28 June 2005 SkyePharma PLC First European Filing for New Aerosol Inhaler Version of AstraZeneca's Pulmicort(R) LONDON, ENGLAND, 28 June, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)announces today that a new pressurized metered-dose aerosol inhaler (pMDI)formulation of the inhaled corticosteroid Pulmicort(R) (budesonide) has beenfiled by AstraZeneca in its first European market. Pulmicort(R) HFA-pMDI willbe available in two strengths, 100 (micro)g and 200 (micro)g, and will be usedfor the treatment of asthma in adults and children. The currently available pMDIformulation of Pulmicort(R) has been on the market since 1981 and useschlorofluorocarbons (CFCs) as the propellant. In accordance with the MontrealProtocol, this will now be replaced by a non-ozone depleting device usinghydrofluoroalkanes (HFA) as propellant. SkyePharma developed the new HFA pMDIdevice, which employs its proprietary formulation technology, and SkyePharmaalso conducted the clinical development programme for AstraZeneca. The filingtriggers a milestone payment to SkyePharma, which will also earn a royalty onAstraZeneca's sales of this formulation of Pulmicort(R). Michael Ashton, SkyePharma's Chief Executive, said: "We are delighted thatPulmicort(R) HFA pMDI has successfully completed clinical development and nowbeen filed. This is another example of the growing family of products based onour portfolio of pulmonary delivery technologies." For further information please contact: SkyePharma PLC +44 207 491 1777Michael 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 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 Pulmicort(R) Pulmicort(R) (budesonide) is an inhaled corticosteroid indicated formaintenance treatment of asthma in children and adults. In some countriesPulmicort(R) is also indicated for maintenance treatment of Chronic ObstructivePulmonary Disease ("COPD"). Pulmicort(R) was first registered and launched in1981 and is now approved in 89 countries. Pulmicort(R) is available in threeadministration forms, a dry powder inhaler (Pulmicort(R) Turbuhaler(R)), as anebulising suspension (Pulmicort(R) Respules(R)) and as a pressurizedMetered-Dose inhaler (Pulmicort(R) pMDI). Pulmicort(R) is a trademark of the AstraZeneca group of companies 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:
SKP.LAstrazeneca