Phase III Trials Approval
Alliance Pharma PLC
06 July 2005
For immediate release 6 July 2005
ALLIANCE PHARMA PLC
('Alliance Pharma' or 'the Company')
Insomnia drug PosidormTM to commence Phase III trials
Alliance Pharma plc (AIM: APH), an emerging speciality pharmaceutical company,
is pleased to announce that it has received UK regulatory approval from the
Medicines and Healthcare products Regulatory Agency (MHRA) to commence Phase III
trials of PosidormTM, the Company's new therapy for sleep disorders.
Alliance Pharma will imminently commence recruitment of patients for the
placebo-controlled, cross-over trials in two indications: the treatment of sleep
disorders in the elderly and in shift workers. A total of 600 patients will be
recruited - divided equally between the two indications.
The results of the trials are expected in 2006, with regulatory approval to
market the drug anticipated in 2007.
Posidorm is a controlled-release tablet containing a synthesised version of the
naturally occurring hormone melatonin, which regulates the sleep/wake cycle and
whose deficiency is the main cause of many sleep disorders.
Alliance Pharma's commercialisation strategy is to market Posidorm via the
Company's own salesforce in the UK and Ireland and to out-license the drug to a
marketing partner or partners in the remainder of European territories.
Posidorm is a major commercial opportunity for Alliance Pharma as around an
estimated 20 million people throughout Europe suffer from melatonin-related
sleep disorders. Only a fraction of these people receive treatment from existing
therapies, such as benzodiazepines, whose use is limited by a sub-optimal safety
and efficacy profile.
Benzodiazepines, and non-benzodiazepine GABA-A agonists, are not labelled for
chronic use and are associated with side effects including withdrawal symptoms,
dependency, next-day residual effects, severe toxicity in overdose and
tolerance.
In addition to the use of Posidorm in the elderly and shift workers, Alliance
Pharma believes the treatment has potential in other indications including sleep
disorders in the blind and as a treatment for jet-lag.
Commenting on the news, John Dawson, Alliance Pharma's Chief Executive, said: '
Sleep disorders are a major issue with serious health, social and safety
consequences. We are therefore delighted to be able to commence Phase III
trials in the UK of Posidorm, a new and much-needed treatment. Posidorm is a
very significant commercial opportunity for the Company as it addresses a market
that is currently estimated at £0.5bn but which is expected to treble in the
next decade.'
For further information:
Alliance Pharma plc + 44 (0) 1249 466966
John Dawson, Chief Executive
Maddy Scott, Finance Director
www.alliancepharma.co.uk
Buchanan Communications + 44 (0) 20 7466 5000
Mark Court/Lisa Baderoon/Rebecca Skye Dietrich
Notes to editors
About Melatonin
Melatonin, which was first isolated in 1958, is a hormone produced by the pineal
gland at the base of the brain. Melatonin production is regulated by the
stimulus of light and it has been shown to have a key role in the control and
maintenance of the sleep/wake cycle. It is one of the most studied substances in
Central Nervous System research, having been the subject, as a therapeutic
agent, of more than 1400 published articles in the medical literature.
Melatonin is widely available in the US as it is classified as a 'dietary
supplement' - even though there are negligible levels of melatonin naturally
occurring in human diets - under the Dietary Supplement Health and Education Act
1994. The Food & Drug Administration has preserved this classification due to
melatonin's lack of overt toxicity.
However, the marketing of melatonin is not permitted in Europe(J1) , where
regulatory authorities judge it should be registered as a pharmaceutical and
supported by full clinical and manufacturing documentation.
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 continues to explore opportunities to expand the range.
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 is also developing novel products for sleep disorders and the
induction of labour.
Alliance Pharma joined the AIM market of the London Stock Exchange in December
2003 and trades under the symbol APH.
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(J1)It is available in certain parts of SE Asia
This information is provided by RNS
The company news service from the London Stock Exchange