Phase III Trials Approval

6 Jul 2005 07:00

Alliance Pharma PLC06 July 2005 For immediate release 6 July 2005 ALLIANCE PHARMA PLC ("Alliance Pharma" or "the Company") Insomnia drug PosidormTM to commence Phase III trials Alliance Pharma plc (AIM: APH), an emerging speciality pharmaceutical company,is pleased to announce that it has received UK regulatory approval from theMedicines and Healthcare products Regulatory Agency (MHRA) to commence Phase IIItrials of PosidormTM, the Company's new therapy for sleep disorders. Alliance Pharma will imminently commence recruitment of patients for theplacebo-controlled, cross-over trials in two indications: the treatment of sleepdisorders in the elderly and in shift workers. A total of 600 patients will berecruited - divided equally between the two indications. The results of the trials are expected in 2006, with regulatory approval tomarket the drug anticipated in 2007. Posidorm is a controlled-release tablet containing a synthesised version of thenaturally occurring hormone melatonin, which regulates the sleep/wake cycle andwhose deficiency is the main cause of many sleep disorders. Alliance Pharma's commercialisation strategy is to market Posidorm via theCompany's own salesforce in the UK and Ireland and to out-license the drug to amarketing partner or partners in the remainder of European territories. Posidorm is a major commercial opportunity for Alliance Pharma as around anestimated 20 million people throughout Europe suffer from melatonin-relatedsleep disorders. Only a fraction of these people receive treatment from existingtherapies, such as benzodiazepines, whose use is limited by a sub-optimal safetyand efficacy profile. Benzodiazepines, and non-benzodiazepine GABA-A agonists, are not labelled forchronic use and are associated with side effects including withdrawal symptoms,dependency, next-day residual effects, severe toxicity in overdose andtolerance. In addition to the use of Posidorm in the elderly and shift workers, AlliancePharma believes the treatment has potential in other indications including sleepdisorders in the blind and as a treatment for jet-lag. Commenting on the news, John Dawson, Alliance Pharma's Chief Executive, said: "Sleep disorders are a major issue with serious health, social and safetyconsequences. We are therefore delighted to be able to commence Phase IIItrials in the UK of Posidorm, a new and much-needed treatment. Posidorm is avery significant commercial opportunity for the Company as it addresses a marketthat is currently estimated at £0.5bn but which is expected to treble in thenext decade." For further information: Alliance Pharma plc + 44 (0) 1249 466966John Dawson, Chief ExecutiveMaddy Scott, Finance Directorwww.alliancepharma.co.uk Buchanan Communications + 44 (0) 20 7466 5000Mark Court/Lisa Baderoon/Rebecca Skye Dietrich Notes to editors About Melatonin Melatonin, which was first isolated in 1958, is a hormone produced by the pinealgland at the base of the brain. Melatonin production is regulated by thestimulus of light and it has been shown to have a key role in the control andmaintenance of the sleep/wake cycle. It is one of the most studied substances inCentral Nervous System research, having been the subject, as a therapeuticagent, of more than 1400 published articles in the medical literature. Melatonin is widely available in the US as it is classified as a "dietarysupplement" - even though there are negligible levels of melatonin naturallyoccurring in human diets - under the Dietary Supplement Health and Education Act1994. The Food & Drug Administration has preserved this classification due tomelatonin's lack of overt toxicity. However, the marketing of melatonin is not permitted in Europe(J1) , whereregulatory authorities judge it should be registered as a pharmaceutical andsupported by full clinical and manufacturing documentation. About Alliance Pharma Alliance Pharma, founded in 1996, is an AIM listedemerging speciality pharmaceutical company based in Chippenham, Wiltshire, UK.The company has a strong track record of acquiring the rights to establishedniche brands and owns, or shares, the rights to 30 branded pharmaceuticalproducts and continues to explore opportunities to expand the range. Alliance Pharma's products are prescribed in the treatment of a wide range ofconditions and include brands used in periodontitis (a serious gum disease), theprevention of heart disease, in Parkinson's disease, in nutrition, in nasalinfections, in the treatment of dermatological conditions and in childbirth. Alliance Pharma's sales are mainly prescription driven. Its products aredistributed to hospitals directly and to pharmaceutical wholesalers whichservice both hospital and retail pharmacies with their prescriptionrequirements. Alliance Pharma is also developing novel products for sleep disorders and theinduction of labour. Alliance Pharma joined the AIM market of the London Stock Exchange in December2003 and trades under the symbol APH. -------------------------- (J1)It is available in certain parts of SE Asia This information is provided by RNS The company news service from the London Stock Exchange