11th Jan 2005 07:00
Alliance Pharma PLC11 January 2005 FOR IMMEDIATE RELEASE 11 January 2005 ALLIANCE PHARMA PLC ("Alliance" or "the Company") PHASE III REGISTRATION TRIALS FOR APL202 (MISOPROSTOL) FOR THE INDUCTION OF LABOUR COMMENCE Alliance Pharma plc, (LSE.APH) the Chippenham-based emerging specialitypharmaceutical company, today announced that it has commenced the registrationtrial programme for its development drug APL202 (misoprostol) for the inductionof labour. Around 20-25% of labours in the UK (150,000 - 175,000 per annum) areinduced and many more may be augmented during labour. Two drugs are usedroutinely to aid in assisted labour. These are dinoprostone (a prostaglandin)for induction and Syntocinon (oxytocin, Alliance) for induction and augmentationof labour. The programme consists of two Phase III trials comparing APL202 withdinoprostone, the first trial in subjects who are presenting with a firstpregnancy and the second trial in subjects who have had a first baby deliveredwithout complications. The multicentre trials will include a total of 1012 subjects in 9 centres aroundthe country. The first subjects have been recruited at the first site into bothstudies and the first baby has already been delivered. These registration trialsare expected to be completed by the summer of this year with the resultsavailable in the second half of the year. Misoprostol has been developed by Alliance as a 25 microgramme intravaginaltablet which can be stored without refrigeration. APL202 will be compared inthese registration trials with dinoprostone, the market leader, at therecommended doses and dose intervals. There is considerable published work onthe efficacy of APL202 for cervical ripening, but until now there has been noproper formulation for this indication. The product is already used "off label"by obstetricians, but requires the cutting of a 200 microgramme oral tablet,which is currently used for gastrointestinal disorders, to get an approximateintravaginal dose. Commenting on the registration trial programme, John Dawson, CEO said: "Thecommencement of the first full Phase III clinical trial that we have undertakenmarks an important milestone for the company as we pursue that arm of ourstrategy that involves bringing our own development products to the market. Weare investing heavily in developing products that should have a significantimpact on the growth of Alliance and at the same time provide better productsfor patients. Current sales of dinoprostone across Europe are approximately £13million and although it is a well established drug, it does requirerefrigeration and many obstetricians prefer to use misoprostol even though theyhave to go to the inconvenience of cutting up the standard 200 microgramme oraltablet. Independent clinical studies have also suggested that misoprostol ismore effective than dinoprostone in reducing the time from induction to deliveryof the baby. So, with the significant benefits that APL202 brings, we cananticipate gaining considerable market share once registration has been achievedand we can market this product alongside Syntocinon with obstetricians." The commencement of Phase III registration trials comes after a very successfulyear for the Company during which sales grew by 13% and the Company acquiredfour dermatology brands through the acquisition of Dermapharm as well asForceval, UniFlu and Periostat. In addition, the Company set up a co-marketingagreement with Valeant Pharmaceuticals for the promotion of Alliance's Symmetralfor Parkinson's disease to geriatricians. For further information please contact: Alliance Pharma plcJohn DawsonCEO01249 466966 Beattie FinancialJames Chandler/Mike Wort/John Moriarty020 7398 3300 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 30 branded pharmaceutical products and iscurrently exploring several opportunities to expand the range. In November 2003the company acquired Peerless Technology Group Plc constituting a reversetakeover under the AIM rules. Alliance's products are prescribed in the treatment of a wide range ofconditions and include brands used in the prevention of heart disease, inParkinson's disease, in nutrition, in nasal infections, in the treatment ofdermatological conditions and in childbirth. Alliance's sales are mainlyprescription driven. They are distributed to hospitals directly and topharmaceutical wholesalers who service both hospital and retail pharmacies withtheir prescription requirements. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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