SKP.L Regulatory News (SKP)

15 Mar 2007 07:01

Skyepharma PLC15 March 2007 For Immediate Release 15 March, 2007 SkyePharma PLC Co-Promotion Agreement for Zileuton CR LONDON, UK, 15 March 2007 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) notes thatits partner for zileuton CR, Critical Therapeutics (CTI), announced that it hasentered into a co-promotion agreement with DEY, L.P., an affiliate of MerckKGaA. The agreement means that a combined sales force of 240 representatives will beavailable to promote zileuton CR, once it receives approval from the Food andDrug Administration ("FDA"). The FDA is reviewing the New Drug Application ("NDA") for zileuton CR, which has a Prescription Drug User Fee Act (PDUFA) dateof May 31, 2007. Product launch is scheduled for the second half of 2007,pending regulatory approval. Zileuton CR uses SkyePharma's proprietary GEOMATRIXoral drug controlled release technology. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating OfficerPeter Grant, Finance Director Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich The Trout Group + 1 617 583 1308Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has nine approved products in the areas of oral,inhalation and topical delivery that are marketed throughout the world byleading pharmaceutical companies. For more information, visitwww.skyepharma.com. About Critical Therapeutics Critical Therapeutics, headquartered Lexington, MA, is developing andcommercializing innovative products for respiratory, inflammatory and criticalcare diseases. The Company owns worldwide rights to ZYFLO(R) (zileuton tablets),which is marketed in the United States for the prevention and chronic treatmentof asthma in patients 12 years of age and older. Critical Therapeutics isworking to expand its zileuton franchise by developing a twice daily,controlled-release formulation for the prevention and chronic treatment ofasthma and an injectable formulation for acute asthma attacks that lead patientsto the emergency room and other urgent care settings. The Company also iscollaborating with MedImmune, Inc. to design antibody therapies that treat acuteand chronic diseases triggered by the inflammatory cytokine HMGB1. Researchpipeline programs include lifecycle management to extend the zileuton franchiseand an alpha-7 project for the treatment of inflammation. For more information,please visit www.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 Exchange