Alliance Pharma plc, (LSE.APH) the Chippenham-based emerging speciality pharmaceutical company, today announced that it has commenced the registration trial programme for its development drug APL202 (misoprostol) for the induction of labour.  Around 20-25% of labours in the UK (150,000 - 175,000 per annum) are induced and many more may be augmented during labour. Two drugs are used routinely to aid in assisted labour.  These are dinoprostone (a prostaglandin) for induction and Syntocinon (oxytocin, Alliance) for induction and augmentation of labour. The programme consists of two Phase III trials comparing APL202 with dinoprostone, the first trial in subjects who are presenting with a first pregnancy and the second trial in subjects who have had a first baby delivered without complications.

The multicentre trials will include a total of 1012 subjects in 9 centres around the country.  The first subjects have been recruited at the first site into both studies and the first baby has already been delivered. These registration trials are expected to be completed by the summer of this year with the results available in the second half of the year.

Misoprostol has been developed by Alliance as a 25 microgramme intravaginal tablet which can be stored without refrigeration. APL202 will be compared in these registration trials with dinoprostone, the market leader, at the recommended doses and dose intervals.  There is considerable published work on the efficacy of APL202 for cervical ripening, but until now there has been no proper 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 approximate intravaginal dose.

Commenting on the registration trial programme, John Dawson, CEO said: 'The commencement of the first full Phase III clinical trial that we have undertaken marks an important milestone for the company as we pursue that arm of our strategy that involves bringing our own development products to the market.  We are investing heavily in developing products that should have a significant impact on the growth of Alliance and at the same time provide better products for patients. Current sales of dinoprostone across Europe are approximately £13 million and although it is a well established drug, it does require refrigeration and many obstetricians prefer to use misoprostol even though they have to go to the inconvenience of cutting up the standard 200 microgramme oral tablet. Independent clinical studies have also suggested that misoprostol is more effective than dinoprostone in reducing the time from induction to delivery of the baby. So, with the significant benefits that APL202 brings, we can anticipate gaining considerable market share once registration has been achieved and we can market this product alongside Syntocinon with obstetricians.'

The commencement of Phase III registration trials comes after a very successful year for the Company during which sales grew by 13% and the Company acquired four dermatology brands through the acquisition of Dermapharm as well as Forceval, UniFlu and Periostat. In addition, the Company set up a co-marketing agreement with Valeant Pharmaceuticals for the promotion of Alliance's Symmetral
for Parkinson's disease to geriatricians.

For further information please contact:

Alliance Pharma plc
John Dawson
CEO
01249 466966

Beattie Financial
James Chandler/Mike Wort/John Moriarty
020 7398 3300