AGI Therapeutics announces completion of the optimisation phase of development
of AGI-010
Dublin, Ireland, and Columbia, MD, USA, 17 March 2008 - AGI Therapeutics plc
("AGI" or the "Company"), a specialty pharmaceuticals company focused on
gastrointestinal drug products, today announces the completion of the
optimisation phase of development of AGI-010, a modified release formulation of
the proton pump inhibitor drug ("PPI") omeprazole which utilizes AGI's CHRONAB
technology.
As part of the optimization phase of development, AGI completed a number of
studies in healthy human volunteers. These studies characterized the drug
release profile, the pharmacokinetics of omeprazole and the intragastric pH
following administration of a number of prototype formulations of AGI-010.
Based on the outcome of these studies, a formulation has been identified which
could have the potential to control intragastric pH during the night.
Commenting on reaching the end of this key stage of development, Dr. John
Devane, Chief Executive Officer of AGI, said:
"We believe we have identified a unique formulation of omeprazole for once
daily administration which could specifically address nocturnal acid
breakthrough (NAB), a real unmet medical need for GERD patients. With our
partner, Axcan Pharma, we will now focus on defining the appropriate development
approach for the remainder of the AGI-010 program."
AGI entered into a co-development and licence agreement with Axcan Pharma Inc.
in September 2006, to jointly develop AGI-010 for North American markets.
Contact Information:
AGI Therapeutics plc. Tel: +353 1 449 3254
David Kelly, Chief Financial Officer
AGI Therapeutics, Inc.
Dr David Young, President, US Operations Tel: +1 443 285 0095
Financial Dynamics - UK Tel: +44 (0) 20 7269 7182
Deborah Scott/Lara Mott
Financial Dynamics - Ireland Tel: +353 1 663 3607
Aisling Garvey
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 (1) 614 8761
John Frain
Notes to Editors:
About AGI-010
AGI-010 is a modified release formulation of the proton pump inhibitor drug
("PPI"), omeprazole which is being developed by AGI for the treatment of
Gastro-Esophageal Reflux Disease ("GERD"), and in particular for the treatment
of Nocturnal Acid Breakthrough ("NAB"), a poorly controlled aspect of GERD.
NAB is estimated to occur in more than 70 per cent of h.pylori-negative and in
up to 50 per cent of h.pylori-positive patients on PPI therapy. Omeprazole is
one of the most commonly prescribed PPI drugs for the treatment of GERD.
AGI has developed CHRONAB, an approach to the formulation of PPIs to
specifically address NAB. AGI's lead CHRONAB formulation is AGI-010, a modified
release formulation of omeprazole, which is designed to be taken once-daily at
dinner time and to release the drug over the late evening/early morning period
to improve acid suppression during the night-time hours.
About AGI Therapeutics plc
AGI is a speciality pharmaceutical company which is focused on the development
and commercialisation of differentiated drug products for gastrointestinal (GI)
diseases and disorders. AGI's common shares are listed on the Alternative
Investment Market of the London Stock Exchange (AIM) and on the Irish Enterprise
Exchange of the Irish Stock Market (IEX) as AGI.
The Company has a portfolio of product candidates derived from its Known
Molecular Entity (KME) approach to drug re-profiling and development. The
Company's lead product candidate, RezularTM, is an orally administered
triple-action intestinal regulator, a first-in-class mechanism for the treatment
of Diarrhoea predominant Irritable Bowel Syndrome, (IBS-D). Rezular is
currently in Phase III clinical trials.
KME is a re-profiling methodology used by the Company to identify existing
therapeutic drugs which typically have been marketed for a number of years, have
established safety profiles and can be developed for new clinical indications or
with improved profiles in their existing clinical indications. In this way, the
Company seeks to reduce the risk, time and cost of new product development as
compared to the development of new chemical entities.
AGI is developing a range of product candidates to treat a variety of prevalent
GI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,
gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) and
diarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). The
Company is targeting areas of the GI therapeutic drug products market for its
product candidates where there are currently unmet medical needs or where the
effectiveness of existing drug therapies can be further improved.
The Company has five active clinical stage product candidates which are either
isomers or new drug delivery formulations of existing approved drugs, and which
have established safety and tolerability profiles in their currently approved
clinical indications.
For further information please see www.agitherapeutics.com
Statements contained within this press release may contain forward-looking
comments which involve risks and uncertainties that may cause actual results to
vary from those contained in the forward-looking statements. In some cases, you
can identify such forward-looking statements by terminology such as 'may', '
will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', '
estimates', 'predicts', 'potential', or 'continue'. Predictions and
forward-looking references in this press release are subject to the satisfactory
progress of research which is, by nature, unpredictable. Forward projections
reflect management's best estimates based on information available at the time
of issue.
This information is provided by RNS
The company news service from the London Stock Exchange
AGI THERAPEUTICS PLC ANNOUNCES RESEARCH UPDATE
| Source: AGI Therapeutics plc
Dublin, Ireland--(Marketwire - March 17, 2008) -