18th Dec 2006 07:02
Skyepharma PLC18 December 2006 For Immediate Release 18 December 2006 SkyePharma PLC FDA APPROVES FORADIL(R) CERTIHALER(TM) LONDON, UK, 18 December 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)announces today that the US Food and Drug Administration (FDA) has approvedFORADIL(R) CERTIHALER(TM) (formoterol fumarate inhalation powder) for thetreatment of asthma. FORADIL(R) CERTIHALER(TM) has been co-developed bySkyePharma and Novartis, and is a trademark of Novartis. The FDA issued an "approvable" letter for FORADIL(R) CERTIHALER in April 2006.Following a recall from the German and Swiss markets in January 2006 becauseof concerns that accidental mishandling of the device may have resulted ininaccurate dosing in a small number of cases. The device was modified and themodifications were submitted to the FDA. The Foradil(R) Certihaler(TM) has been approved in 27 countries outside the USA,and SkyePharma is in discussion with Novartis with respect to commercial launchin these territories. SkyePharma earns a royalty on sales of FORADIL(R) CERTIHALER(TM) in all markets.SkyePharma also manufactures and supplies the FORADIL(R) CERTIHALER(TM). Frank Condella, CEO, SkyePharma said: "We are extremely pleased by the FDA's decision to approve the modifications toFORADIL(R) CERTIHALER(TM). We believe that this approval validates SkyePharma'sinhalation technology and paves the way to future products." For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich The Trout Group + 1 617 583 1308Seth Lewis 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 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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