Alliance Pharma Regulatory News (APH)

15 Jan 2007 07:01

Alliance Pharma PLC15 January 2007 For immediate release 15 January 2007 ALLIANCE PHARMA PLC ("Alliance Pharma" or "the Company") Trading and Product Development Update Alliance Pharma plc (AIM: APH), the emerging speciality pharmaceutical company,announces that its sales for the 12 months to 31st December 2006 were £17.3m,an increase of 19.7% over the 12 months to December 2005. Like for like growthwas 7.7% with the additional growth derived from brands acquired in the period.As anticipated at the time of the Interim Results, profitability has beenrestored to a satisfactory level. Preliminary results are now available from the pilot phases, in shiftworkers andelderly patients, of the Phase III trials of Posidorm, the Company's melatoninproduct for sleep disorders. These results indicate a significant improvementin sleep duration compared with placebo when using the objective measure ofactigraphy, a sleep-measuring device. Additionally in the shiftworker group,performance measurements during the night showed improvements for trialparticipants on Posidorm. In both groups, Posidorm was well tolerated, therebeing no difference in the incidence of reported side-effects compared withplacebo. Whilst the pilot trials have been successful, the Company has been advised bythe European Medicines Agency (also known as EMEA) that additional safety anddose confirmation studies will be required. The original plan for Posidorm'sdevelopment was based on discussions with the UK Medicines and Healthcareproducts Regulatory Agency (MHRA), which took into account the extensive medicaland scientific literature on melatonin. That plan envisaged UK registrationfirst, followed by registration in other European countries. The pan-Europeanregistration routes that now have to be followed take less account of theaccumulated knowledge about melatonin. The effect of this change in regulatoryapproach will delay the anticipated completion of development from Q4 07 to Q409 and will involve extra cost, currently estimated to be in the range of £4m to£6m. Market research studies have shown there is a clear need for new products forsleep disorders that avoid the problems of habituation and next day "hangovers".The potential European sales for such products have been estimated to be in therange of £100m - £200m, with the market projected to develop significantly onthe entry of new products. The major Phase III efficacy trials of the Company's other development project,Isprelor, misoprostol for the induction of labour, are close to completion. John Dawson, Alliance Pharma's Chief Executive, said: "I am delighted by thenear 20% growth in full year sales and the Company's profitable performance.While the additional guidance on Posidorm from the EMEA involves further timeand cost, it does give a clear pathway through the registration process andallows an optimised pan-European product launch. We are currently looking atvarious options, including co-development, for bringing Posidorm to market inthe quickest possible time." Preliminary results for the 12 month period to 31 December 2006 will beannounced on 22 March 2007. 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 Dietrich Notes to editors About Alliance Pharma Alliance Pharma, founded in 1996, is an AIM listed emerging specialitypharmaceutical company based in Chippenham, Wiltshire, UK. The company has astrong track record of acquiring the rights to established niche brands andowns, or shares, the rights to 34 branded pharmaceutical products and continuesto 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. This information is provided by RNS The company news service from the London Stock Exchange