Alliance Pharma PLC
11 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 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
About Alliance Pharma
Alliance Pharma, founded in 1996, is an AIM listed emerging 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 30 branded pharmaceutical products and is
currently exploring several opportunities to expand the range. In November 2003
the company acquired Peerless Technology Group Plc constituting a reverse
takeover under the AIM rules.
Alliance's products are prescribed in the treatment of a wide range of
conditions and include brands used in the prevention of heart disease, in
Parkinson's disease, in nutrition, in nasal infections, in the treatment of
dermatological conditions and in childbirth. Alliance's sales are mainly
prescription driven. They are distributed to hospitals directly and to
pharmaceutical wholesalers who service both hospital and retail pharmacies with
their prescription requirements.
This information is provided by RNS
The company news service from the London Stock Exchange
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