Dublin, Ireland, and Columbia, MD, USA, 17 March 2008
AGI Therapeutics announces completion of the optimisation
phase of development of AGI-010
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
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Deborah Scott/Lara Mott
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Aisling Garvey
Tel: +353 1 663 3607
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
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
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 the Known Molecular Entity (''KME'') approach to drug re-profiling and development. 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, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. 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 six 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. These product candidates are all in clinical development, including five Phase II trials.
AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.
Statements contained within this press release may contain forward-looking comments that 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.