Phase III Trials Approval

Alliance Pharma PLC 06 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 the Medicines and Healthcare products Regulatory Agency (MHRA) to commence Phase III trials of PosidormTM, the Company's new therapy for sleep disorders. Alliance Pharma will imminently commence recruitment of patients for the placebo-controlled, cross-over trials in two indications: the treatment of sleep disorders in the elderly and in shift workers. A total of 600 patients will be recruited - divided equally between the two indications. The results of the trials are expected in 2006, with regulatory approval to market the drug anticipated in 2007. Posidorm is a controlled-release tablet containing a synthesised version of the naturally occurring hormone melatonin, which regulates the sleep/wake cycle and whose deficiency is the main cause of many sleep disorders. Alliance Pharma's commercialisation strategy is to market Posidorm via the Company's own salesforce in the UK and Ireland and to out-license the drug to a marketing partner or partners in the remainder of European territories. Posidorm is a major commercial opportunity for Alliance Pharma as around an estimated 20 million people throughout Europe suffer from melatonin-related sleep disorders. Only a fraction of these people receive treatment from existing therapies, such as benzodiazepines, whose use is limited by a sub-optimal safety and efficacy profile. Benzodiazepines, and non-benzodiazepine GABA-A agonists, are not labelled for chronic use and are associated with side effects including withdrawal symptoms, dependency, next-day residual effects, severe toxicity in overdose and tolerance. In addition to the use of Posidorm in the elderly and shift workers, Alliance Pharma believes the treatment has potential in other indications including sleep disorders 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 safety consequences. We are therefore delighted to be able to commence Phase III trials in the UK of Posidorm, a new and much-needed treatment. Posidorm is a very significant commercial opportunity for the Company as it addresses a market that is currently estimated at £0.5bn but which is expected to treble in the next decade.' For further information: Alliance Pharma plc + 44 (0) 1249 466966 John Dawson, Chief Executive Maddy Scott, Finance Director www.alliancepharma.co.uk Buchanan Communications + 44 (0) 20 7466 5000 Mark Court/Lisa Baderoon/Rebecca Skye Dietrich Notes to editors About Melatonin Melatonin, which was first isolated in 1958, is a hormone produced by the pineal gland at the base of the brain. Melatonin production is regulated by the stimulus of light and it has been shown to have a key role in the control and maintenance of the sleep/wake cycle. It is one of the most studied substances in Central Nervous System research, having been the subject, as a therapeutic agent, of more than 1400 published articles in the medical literature. Melatonin is widely available in the US as it is classified as a 'dietary supplement' - even though there are negligible levels of melatonin naturally occurring in human diets - under the Dietary Supplement Health and Education Act 1994. The Food & Drug Administration has preserved this classification due to melatonin's lack of overt toxicity. However, the marketing of melatonin is not permitted in Europe(J1) , where regulatory authorities judge it should be registered as a pharmaceutical and supported by full clinical and manufacturing documentation. About Alliance Pharma Alliance Pharma, founded in 1996, is an AIM listed emerging speciality pharmaceutical company based in Chippenham, Wiltshire, UK. The company has a strong track record of acquiring the rights to established niche brands and owns, or shares, the rights to 30 branded pharmaceutical products and continues to explore opportunities to expand the range. Alliance Pharma's products are prescribed in the treatment of a wide range of conditions and include brands used in periodontitis (a serious gum disease), the prevention of heart disease, in Parkinson's disease, in nutrition, in nasal infections, in the treatment of dermatological conditions and in childbirth. Alliance Pharma's sales are mainly prescription driven. Its products are distributed to hospitals directly and to pharmaceutical wholesalers which service both hospital and retail pharmacies with their prescription requirements. Alliance Pharma is also developing novel products for sleep disorders and the induction of labour. Alliance Pharma joined the AIM market of the London Stock Exchange in December 2003 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
UK 100