1st Aug 2006 14:00
Skyepharma PLC01 August 2006 For Immediate Release 1 August, 2006 Critical Therapeutics Files Controlled Release Formulation of Zileuton LONDON, UK, 1 August 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcesthat its partner Critical Therapeutics Inc ("CTI", Nasdaq: CRTX) has submitted aNew Drug Application to the US Food & Drug Administration for acontrolled-release formulation of the oral anti-inflammatory drug zileuton forasthma in adults and children aged 12 years or older. The new formulation onlyneeds to be taken twice a day whereas Zyflo(R), the currently marketed versionof zileuton, has the drawback of requiring dosing four times a day. A four times a day immediate-release version of zileuton was marketed by AbbottLaboratories ("Abbott") as Zyflo(R) Filmtab(R) (zileuton tablets). SkyePharmadeveloped a controlled-release formulation of zileuton, using its GeomatrixTMtechnology, for Abbott, which completed Phase III development in asthma withthis product. CTI acquired the rights to zileuton from Abbott and since December2003 SkyePharma has collaborated with CTI on the further development of thisformulation. SkyePharma will receive a single-digit royalty on CTI's sales ofthe controlled-release formulation of zileuton and will also manufacture theproduct for CTI at its plant in Lyon, France. Frank Condella, Chief Executive of SkyePharma, said: "We are pleased that thissuccessful collaboration with CTI has now culminated in the filing of thisversion of zileuton, another example of the power of our GeomatrixTM technology.Our partner expects this product to reach the market in the second half of nextyear when it will become another source of royalty and manufacturing income forSkyePharma." For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications 44 207 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich 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 twelve 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 criticalcare medicine. CTI's mission is the discovery, development and commercializationof novel therapies for the treatment of acute trauma, cardiopulmonary diseaseand infectious and inflammatory illness. The Company is headquartered inCambridge, Massachusetts. More information about CTI is available atwww.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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