Alliance Pharma Regulatory News (APH)

23 Jul 2007 07:00

Alliance Pharma PLC23 July 2007 For immediate release 23 July 2007 ALLIANCE PHARMA PLC ("Alliance" or "the Company") Successful Phase III Trial Results of Isprelor in Induction of Labour Alliance Pharma plc (AIM: APH), the speciality pharmaceutical company, ispleased to announce positive Phase III trial results for Isprelor, a vaginaltablet containing 25mg of misoprostol for the induction of labour. The trial,conducted in more than 600 women, was a direct comparison of Isprelor versusdinoprostone, which is the current standard treatment. As anticipated, the results showed that the two treatments were similarlyefficacious; there was no statistical difference between Isprelor anddinoprostone in the ability to produce a vaginal delivery within 24 hours ofcommencing treatment. However nausea, which is a well-known side effect ofdinoprostone, was seen less frequently with Isprelor. No unexpected adverseevents were seen with Isprelor and, most importantly, Isprelor was shown to beno more likely than dinoprostone to cause hyperstimulation of the uterus. The induction of labour occurs in around 1 in 5 pregnancies, usually because thepregnancy continues beyond 41 weeks or because of complications, such as highblood pressure. The Royal College of Obstetricians and Gynaecologists and other obstetriciansworldwide, had called for a purpose-designed vaginal formulation of misoprostolowing to the growing off-label use of oral misoprostol tablets, which areindicated only to treat stomach ulcers. Additionally, unlike dinoprostone,Isprelor does not require refrigerated storage, which brings added convenience. As previously announced, Alliance intends to file for registration of Isprelorin Europe in the second half of 2008. John Dawson, Alliance Pharma's Chief Executive, said: "The positive results fromthis trial will form an important part of our ongoing out-licensing negotiationsfor Isprelor. This pivotal trial shows that Isprelor is as effective and as welltolerated in initiating labour as the current standard treatment and we lookforward to delivering to the obstetric communities the product that they calledfor." For further information: Alliance Pharma plc + 44 (0) 1249 466966John Dawson, Chief Executive Richard Wright, Finance Directorwww.alliancepharma.co.uk Numis Securities + 44 (0) 20 7260 1000David PoutneyMichael Meade Buchanan Communications + 44 (0) 20 7466 5000Mark Court/Rebecca Skye Dietrich Notes to editors About Alliance Pharma Alliance Pharma, founded in 1996, is an AIM listed speciality pharmaceuticalcompany based in Chippenham, Wiltshire, UK. The company has a strong trackrecord of acquiring the rights to established niche brands and owns, or shares,the rights to 34 branded pharmaceutical products. 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 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