31st May 2007 12:30
Skyepharma PLC31 May 2007 TWICE DAILY ZYFLO CR(TM) (ZILEUTON) EXTENDED-RELEASE TABLETS APPROVED BY THE FDA FOR ASTHMA LONDON, UK, Thursday, May 31, 2007 - SkyePharma PLC (LSE: SKP) today announcesthat the U.S. Food and Drug Administration (FDA) has approved CriticalTherapeutics, Inc.'s (Nasdaq: CRTX) New Drug Application (NDA) for twice-dailyZYFLO CR(TM) (zileuton) extended-release tablets. ZYFLO CR uses SkyePharma PLC'sproprietary Geomatrix(R) drug delivery technology, which controls the amount andrate of drug released into the body. ZYFLO CR and ZYFLO(R) (zileuton tablets) are the only FDA-approved leukotrienesynthesis inhibitors for the prophylaxis and chronic treatment of asthma inadults and children 12 years of age and older. ZYFLO CR and ZYFLO are notindicated for use in the reversal of bronchospasm in acute asthma attacks, butcan be continued during acute exacerbations of asthma. Leukotrienes areinflammatory mediators in asthma that can trigger asthma symptoms, includinginflammation, swelling, bronchoconstriction and mucus secretion. CriticalTherapeutics expects to begin marketing ZYFLO CR in the U.S. together with itsco-promotion partner, Dey, L.P. (DEY) in the autumn of 2007. Frank Condella, Chief Executive Officer of SkyePharma, said: "The approval ofZYFLO CR is another successful application of our Geomatrix oralcontrolled-release technology. We continue our focus on oral and inhalationproducts as we build our business moving forward." Upon the launch of ZYFLO CR, Critical Therapeutics and DEY's combined salesforce of 240 representatives will begin promoting ZYFLO CR to approximately15,000 allergists, pulmonologists and primary care physicians across the U.S.SkyePharma will receive a high mid single digit royalty on sales of ZYFLO CR. For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth 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 eleven approved products in the areas of oral,inhalation and topical delivery that are marketed throughout the world byleading pharmaceutical companies. For more information, visit www.skyepharma.com About ZYFLO CR and ZYFLO ZYFLO CR 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 and ZYFLO are not indicated for use in thereversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR andZYFLO CR can be continued during acute exacerbations of asthma. The recommended dose of ZYFLO CR 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 is one 600 mg immediate-releasetablet four times a day for a total daily dose of 2400 mg. ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease ortransaminase elevations greater than or equal to three times the upper limit ofnormal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO(1.9%) in placebo-controlled trials showed an increased release of a liverenzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). Asa result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLOshould be measured by a simple blood test. It is recommended that physiciansperform this test before administering ZYFLO CR and ZYFLO and repeat the test ona regular basis while patients are on the medication. Patients taking ZYFLO CRand theophylline should reduce the theophylline dose by 50%. Patients takingZYFLO CR and propranolol or warfarin should be monitored and doses adjusted asappropriate. Most common side effects associated with the use of ZYFLO CR andZYFLO are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upsetstomach and nausea, respectively. For full prescribing information for ZYFLO CR, please visit www.zyflocr.com orcall Critical Therapeutics at +1-866-835-8216 to request medical information. For full prescribing information for ZYFLO, please visit www.zyflo.com or call+1-866-835-8216 to request medical information. ZYFLO(R) and ZYFLO CR(TM) are trademarks of Critical Therapeutics, Inc.Geomatrix(R) is a registered trademark of SkyePharma PLC. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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