SKP.L Regulatory News (SKP)

27 Sep 2007 13:00

Skyepharma PLC27 September 2007 For Immediate Release 27 September 2007 ZYFLO CR(TM)(ZILEUTON) EXTENDED-RELEASE TABLETS LAUNCHED IN THE US LONDON, UK, and Lexington, MA, USA - 27 September 2007 -- SkyePharma PLC (LSE:SKP) and its US marketing partner, Critical Therapeutics, Inc (Nasdaq: CRTX)announce the nationwide US launch today of ZYFLO CR(TM)(zileuton)extended-release tablets for the prevention and chronic treatment of asthma inadults and children 12 years of age and older. With a combined 240-person U.S. sales force Critical Therapeutics, and itsco-promotion partner Dey L.P., an affiliate of Merck KGaA, will targetapproximately 18,000 allergists, pulmonologists and primary care physiciansthroughout the US. At an analyst day held by Critical Therapeutics on Tuesday 25 September 2007,the inclusion of zileuton in new guidelines issued by the National AsthmaEducation and Prevention Programme (NAEPP) was highlighted by Allan Luskin,M.D., Clinical Associate Professor of Medicine, University of Wisconsin andDirector of the Respiratory Institute, Dean Medical Center, Madison, Wisconsin,who spoke to the audience as part of an expert physician panel. Dr Luskin said,"At least one-third of asthma patients' medications do not provide them with thenecessary relief from their symptoms. The new NAEPP guidelines which nowrecommend zileuton as a therapeutic alternative, will be widely distributedamongst leading respiratory specialists and will incorporate new treatmentoptions, which may improve clinical control for asthma patients." ZYFLO CR(TM)and ZYFLO are the only FDA-approved leukotriene synthesis inhibitorsfor the prophylaxis and chronic treatment of asthma in adults and children 12years of age and older. ZYFLO CR(TM)and ZYFLO are not indicated for use in thereversal of bronchospasm in acute asthma attacks, but can be continued duringacute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthmathat can trigger asthma symptoms, including inflammation, swelling,bronchoconstriction and mucus secretion. ZYFLO CR(TM)uses SkyePharma's proprietary Geomatrix(R) drug delivery technology,which controls the amount and rate of drug released into the body. Frank Condella, CEO of SkyePharma PLC said: "We are delighted with the launch ofZYFLO CR(TM)in the US. ZYFLO CR(TM)will provide physicians with an additionaltreatment option for the many asthmatics who have not been able to gainsymptomatic control despite their current therapies." For further information please contact:SkyePharma PLC Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer +44 207 491 1777Peter Grant, Finance Director Financial Dynamics (London enquiries)David Yates / Deborah Scott +44 207 831 3113 Trout Group (US enquiries)Christine Labaree / Seth Lewis +1 617 583 1308 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 eleven approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe world by leading pharmaceutical companies. For more information, visitwww.skyepharma.com. About Critical Therapeutics Critical Therapeutics, Inc. is developing and commercializing innovativeproducts for respiratory, inflammatory and critical care diseases. The Companyowns worldwide rights to two FDA-approved drugs for the prevention and chronictreatment of asthma in patients 12 years of age and older: twice-daily ZYFLOCR(TM)(zileuton) extended-release tablets and ZYFLO(R) (zileuton tablets).Critical Therapeutics is working to develop products for adjunctive use in acuteasthma attacks that lead patients to the emergency room and other urgent caresettings. The Company also is developing therapies directed toward the body'sinflammatory response. Critical Therapeutics is located in Lexington, Mass. Formore information, please visit www.crtx.com. About ZYFLO CR(TM)and ZYFLO(R) ZYFLO CR(TM)and ZYFLO(R) (zileuton tablets) are the only FDA-approvedleukotriene synthesis inhibitors for the prophylaxis and chronic treatment ofasthma in adults and children 12 years of age and older. ZYFLO CR(TM)andZYFLO(R) are not indicated for use in the reversal of bronchospasm in acuteasthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthmasymptoms, including inflammation, swelling, bronchoconstriction and mucussecretion. ZYFLO CR(TM)uses SkyePharma PLC's (LSE: SKP) proprietaryGeomatrix(R) drug delivery technology, which controls the amount and rate ofdrug released into the body. The recommended dose of ZYFLO CR(TM)is two 600 mg extended-release tablets twicedaily, within one hour after morning and evening meals, for a total daily doseof 2400 mg. The recommended dose of ZYFLO(R) is one 600 mg immediate-releasetablet four times a day for a total daily dose of 2400 mg. ZYFLO CR(TM)and ZYFLO(R) are contraindicated in patients with active liverdisease or transaminase elevations greater than or equal to three times theupper limit of normal. A small percentage of patients treated with ZYFLO CRTM(2.5%) and ZYFLO(R) (1.9%) in placebo-controlled trials showed an increasedrelease of a liver enzyme known as ALT and bilirubin (an orange or yellowishpigment in bile). As a result, the level of liver enzymes in patients treatedwith ZYFLO CR(TM)and ZYFLO(R) should be measured by a simple blood test. It isrecommended that physicians perform this test before administering ZYFLO CRTMand ZYFLO(R) and repeat the test on a regular basis while patients are on themedication. Patients taking ZYFLO CR(TM)and theophylline should reduce thetheophylline dose by 50%. Patients taking ZYFLO CR(TM)and propranolol orwarfarin should be monitored and doses adjusted as appropriate. Most common sideeffects associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis,nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea,respectively. For full prescribing information for ZYFLO CRTM, please visit www.zyflocr.com orcall Critical Therapeutics' toll free telephone number 1-866-835-8216 to requestmedical information. For full prescribing information for ZYFLO(R), please visit www.zyflo.com orcall Critical Therapeutics' toll free telephone number 1-866-835-8216 to requestmedical information. This information is provided by RNS The company news service from the London Stock Exchange