24th Oct 2006 07:01
Skyepharma PLC24 October 2006 For Immediate Release 24 October, 2006 SkyePharma PLC FDA accepts New Drug Application for zileuton CR LONDON, ENGLAND, 24 October, 2006 -- SkyePharma PLC (LSE: SKP; NASDAQ: SKYE)today announces that Critical Therapeutics, Inc (NASDAQ: CRTX) has recentlyreceived acceptance from the FDA for its New Drug Application (NDA) for thetwice-daily, controlled-release formulation of zileuton (zileuton CR). Zileuton CR is an investigational drug developed for the prevention and chronictreatment of asthma in adults and children 12 years of age and older. CriticalTherapeutics (CRTX) submitted the NDA in late July and, pending regulatoryapproval, expects to launch zileuton CR in the second half of 2007. Theanticipated PDUFA date is 31 May 2007. Frank Condella, CEO, SkyePharma said: "This is another important step in a successful collaboration and continuedvalidation of our GeomatrixTM technology. We look forward to the productreaching the market, which we hope will begin to generate revenue in the next 12months." 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. About Critical Therapeutics Critical Therapeutics, Inc. is a biopharmaceutical company focused on thediscovery, development and commercialization of products for respiratory,inflammatory and critical care diseases. The Company owns worldwide rights tothe asthma drug ZYFLO(R) (zileuton tablets), as well as other formulations ofzileuton. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing bythe U.S. Food and Drug Administration. The Company's commercialization effortsfor ZYFLO are carried out by its specialty sales force. Critical Therapeuticsalso is developing treatments directed toward the severe inflammatory responsein acute diseases and conditions that lead to admission to the emergency room orintensive care unit, and acute exacerbations of other chronic diseases thatfrequently lead to hospitalization. For more information, please visitwww.crtx.com. About zileuton Zileuton is a highly potent oral anti-inflammatory drug. It works by inhibitingthe enzyme 5-lipoxygenase. This enzyme, which is involved in the formation ofleukotrienes, is a key part of the inflammatory cascade that follows allergicchallenge. Inhibition of this enzyme therefore helps minimisebronchoconstriction and mucus secretion in asthma. In its pivotal trials inadult asthma, zileuton was shown to bring the greatest benefit to those with themost severe disease. Zileuton is not intended for acute relief of asthmasymptoms but chronic treatment with zileuton allows reduction of other therapiessuch as oral steroids which have undesirable side-effects. 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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