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TEMPUS trial starts in US

16 Oct 2007 07:00

Minster Pharmaceuticals PLC16 October 2007 For immediate release 16 October 2007 MINSTER PHARMACEUTICALS PLC ("Minster" or "the Company") TEMPUS study of tonabersat commences Minster Pharmaceuticals plc (AIM: MPM), the drug development company specialising in neurological and psychiatric disorders, is pleased to announce that the first patients have entered the Company's TEMPUS study in the US of tonabersat in the preventive treatment of migraine. The TEMPUS study (Tonabersat Evaluation in Migraine Prevention in the United States) is a Phase IIb trial of around 500 patients and follows encouraging results from a smaller Phase IIa trial that reported earlier this year. The primary endpoint of the TEMPUS study, which will report in Q4 2008, is the reduction in the number of migraine attacks that patients suffer during the last eight weeks of a 20 week treatment period. The treatment period in the TEMPUS trial is significantly longer than the 12 week treatment period in the earlier Phase IIa trial as the earlier trial suggested that the therapeutic effect of tonabersat was still increasing at the end of the 12 week period, indicating that it takes some time for migraine patients to respond optimally to tonabersat. The TEMPUS trial will also take advantage of the encouraging tolerability profile seen in the earlier study by exploring the effects of increasing the dose of tonabersat. The principal investigator for the study is Professor Richard Lipton, Professor & Vice Chair of Neurology and Professor of Epidemiology and Population Health at the Albert Einstein College of Medicine in New York. The study, which will involve patients receiving either tonabersat or placebo on a once-daily basis, has attracted many of the key opinion leaders in migraine at specialist and general centres throughout the US. Tonabersat, Minster's lead compound, is in an exciting new class of drugs calledgap junction blockers that offer the potential to prevent the onset of migraineas a preferred alternative to acute, abortive treatment of headaches, a marketdominated by triptans. Paul Sharpe, Minster Pharmaceuticals' Chief Executive, said: "Tonabersat isseeking to address a clearly unmet medical need in the preventive treatment ofmigraine so I am delighted that the TEMPUS study has now started. The extent ofthis unmet need is reinforced by the fact that key opinion leaders view migraineas a significantly under-diagnosed and under-treated condition, highlighting thecommercial opportunity presented by a new approach to migraine management." For further information: Minster Pharmaceuticals plc Tel: +44 (0) 1799 506623Paul Sharpe, Chief Executive OfficerRobert Aubrey, Chief Financial Officer Buchanan Communications Tel: +44 (0) 20 7466 5000Mark CourtRebecca Skye Dietrich Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200Richard PottsGerard Harper Notes for editors: About Minster Pharmaceuticals plc Minster Pharmaceuticals is a drug development company focussed on neurologicaland psychiatric disorders. Its principal pipeline assets are tonabersat, underdevelopment in the preventive treatment of migraine, and sabcomeline inschizophrenia. Worldwide rights to both compounds were acquired fromGlaxoSmithKline and the compounds benefit from comprehensive safety tolerancedata as a result of investment by GSK. Tonabersat is the most advanced compound in an exciting new class of drugscalled gap junction blockers, which have significant potential in the preventionof migraine and other major neurological conditions. Sabcomeline, a muscarinicpartial agonist, has potential in the treatment of chronic schizophrenia. Minster's near-term focus is on the development and commercialisation of itscurrent pipeline. Its medium term strategy is to leverage the anticipatedcashflows from the current pipeline by in-licensing further compounds with theultimate objective of creating a substantial and highly efficient drugdevelopment enterprise focussed on the central nervous system. Minster joined the AIM market in February 2005 and trades under the symbol MPM.For further information please visit www.minsterpharma.com . This information is provided by RNS The company news service from the London Stock Exchange
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