17th Mar 2008 10:00
AGI Therapeutics plc17 March 2008 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 ongastrointestinal drug products, today announces the completion of theoptimisation phase of development of AGI-010, a modified release formulation ofthe proton pump inhibitor drug ("PPI") omeprazole which utilizes AGI's CHRONABtechnology. As part of the optimization phase of development, AGI completed a number ofstudies in healthy human volunteers. These studies characterized the drugrelease profile, the pharmacokinetics of omeprazole and the intragastric pHfollowing administration of a number of prototype formulations of AGI-010.Based on the outcome of these studies, a formulation has been identified whichcould have the potential to control intragastric pH during the night. Commenting on reaching the end of this key stage of development, Dr. JohnDevane, Chief Executive Officer of AGI, said: "We believe we have identified a unique formulation of omeprazole for oncedaily administration which could specifically address nocturnal acidbreakthrough (NAB), a real unmet medical need for GERD patients. With ourpartner, Axcan Pharma, we will now focus on defining the appropriate developmentapproach 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 3254David 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 7182Deborah Scott/Lara Mott Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey Piper Jaffray Limited Tel: +44 (0) 20 3142 8700Neil MackisonWill CarnwathDavy Tel: +353 (1) 614 8761John 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 ofGastro-Esophageal Reflux Disease ("GERD"), and in particular for the treatmentof 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 inup to 50 per cent of h.pylori-positive patients on PPI therapy. Omeprazole isone of the most commonly prescribed PPI drugs for the treatment of GERD. AGI has developed CHRONAB, an approach to the formulation of PPIs tospecifically address NAB. AGI's lead CHRONAB formulation is AGI-010, a modifiedrelease formulation of omeprazole, which is designed to be taken once-daily atdinner time and to release the drug over the late evening/early morning periodto improve acid suppression during the night-time hours. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (GI)diseases and disorders. AGI's common shares are listed on the AlternativeInvestment Market of the London Stock Exchange (AIM) and on the Irish EnterpriseExchange of the Irish Stock Market (IEX) as AGI. The Company has a portfolio of product candidates derived from its KnownMolecular Entity (KME) approach to drug re-profiling and development. TheCompany's lead product candidate, RezularTM, is an orally administeredtriple-action intestinal regulator, a first-in-class mechanism for the treatmentof Diarrhoea predominant Irritable Bowel Syndrome, (IBS-D). Rezular iscurrently in Phase III clinical trials. KME is a re-profiling methodology used by the Company to identify existingtherapeutic drugs which typically have been marketed for a number of years, haveestablished safety profiles and can be developed for new clinical indications orwith improved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) anddiarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). TheCompany is targeting areas of the GI therapeutic drug products market for itsproduct candidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has five active clinical stage product candidates which are eitherisomers or new drug delivery formulations of existing approved drugs, and whichhave established safety and tolerability profiles in their currently approvedclinical indications. For further information please see www.agitherapeutics.com Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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