Alliance Pharma PLC
23 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, is
pleased to announce positive Phase III trial results for Isprelor, a vaginal
tablet containing 25mg of misoprostol for the induction of labour. The trial,
conducted in more than 600 women, was a direct comparison of Isprelor versus
dinoprostone, which is the current standard treatment.
As anticipated, the results showed that the two treatments were similarly
efficacious; there was no statistical difference between Isprelor and
dinoprostone in the ability to produce a vaginal delivery within 24 hours of
commencing treatment. However nausea, which is a well-known side effect of
dinoprostone, was seen less frequently with Isprelor. No unexpected adverse
events were seen with Isprelor and, most importantly, Isprelor was shown to be
no more likely than dinoprostone to cause hyperstimulation of the uterus.
The induction of labour occurs in around 1 in 5 pregnancies, usually because the
pregnancy continues beyond 41 weeks or because of complications, such as high
blood pressure.
The Royal College of Obstetricians and Gynaecologists and other obstetricians
worldwide, had called for a purpose-designed vaginal formulation of misoprostol
owing to the growing off-label use of oral misoprostol tablets, which are
indicated 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 Isprelor
in Europe in the second half of 2008.
John Dawson, Alliance Pharma's Chief Executive, said: 'The positive results from
this trial will form an important part of our ongoing out-licensing negotiations
for Isprelor. This pivotal trial shows that Isprelor is as effective and as well
tolerated in initiating labour as the current standard treatment and we look
forward to delivering to the obstetric communities the product that they called
for.'
For further information:
Alliance Pharma plc + 44 (0) 1249 466966
John Dawson, Chief Executive
Richard Wright, Finance Director
www.alliancepharma.co.uk
Numis Securities + 44 (0) 20 7260 1000
David Poutney
Michael Meade
Buchanan Communications + 44 (0) 20 7466 5000
Mark Court/Rebecca Skye Dietrich
Notes to editors
About Alliance Pharma
Alliance Pharma, founded in 1996, is an AIM listed 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 34 branded pharmaceutical products.
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 joined the AIM market of the London Stock Exchange in December
2003 and trades under the symbol APH.
This information is provided by RNS
The company news service from the London Stock Exchange MSCILFIRDVIIFID
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