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AGI Therapeutics plc: AGI Therapeutics Announces Termination of Agreement With Axcan for AGI-010

^{Published on 2009-08-13 23:48:44, Last Modified on 2009-08-13 23:48:54 - Market Wire}
 

DUBLIN, IRELAND--(Marketwire - August 14, 2009) -

 AGI announces termination of agreement with Axcan for AGI-010 Dublin, Ireland, 14th August, 2009 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, today announces that its co-development/co-fund and licensing agreement for AGI-010 with Axcan Pharma Inc. ("Axcan"), a privately-held, leading specialty pharmaceutical company in the field of gastroenterology, has been terminated by mutual agreement. AGI-010 is the Company's bimodal modified release once-daily formulation of the proton pump inhibitor drug (PPI) omeprazole for the treatment of gastro-esophageal reflux disorder ("GERD"). AGI now regains full control of AGI-010 and neither party has any outstanding or future obligations to the other. AGI and Axcan entered into a co-development/co-fund and license agreement in September 2006 to jointly develop AGI-010 for North American markets and the parties have worked together since then to develop and optimise the formulation and conduct human clinical testing. AGI announced last year that it had identified an optimised formulation of AGI-010 omeprazole for once daily administration which, the Company believes, can improve control of night-time acid, a prevalent and unmet aspect of GERD. Recently, AGI met with the US Food and Drug Administration ("FDA") who confirmed that AGI-010 can be registered in the US under the NDA 505(b)2 regulatory pathway. AGI has already completed a number of human clinical studies which demonstrate that the optimised formulation of AGI-010 achieves: - a bimodal plasma level profile through its combination of delayed and controlled release beads - an extended plasma level profile consistent with once-daily administration - matching AUC and overall 24-hour gastric pH compared to Prilosec® - greater night-time control of acidity compared to Prilosec® Commenting, Dr. John Devane, CEO, said ''We have had a productive association with Axcan in developing the AGI-010 product to this advanced stage. The return of all rights, without any further financial obligations, is, we believe, consistent with the business strategy review currently underway at AGI. We will now seek to license this product to a new licensee who will complete the development and NDA filing and ultimately the commercialisation of AGI-010.'' Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254 David Kelly, Chief Financial Officer FD - UK Tel: +44 (0) 20 7269 7205 Jonathan Birt/John Dineen FD - Ireland Tel: +353 1 663 3607 Niamh Lyons Piper Jaffray Limited Tel: +44 (0) 20 3142 8700 Neil Mackison Will Carnwath Davy Tel: +353 1 614 8761 John Frain Axcan Pharma Inc. Isabelle Adjahi, Senior Director, Tel: + 1 450-536-7696 Investor Relations and Communications For further information please see [ www.agitherapeutics.com ]. Notes to Editors: About AGI-010 and GERD AGI-010 is a modified bimodal release once-daily formulation of the proton pump inhibitor drug (PPI) omeprazole based on AGI's CHRONAB technology which the Company believes will be effective in controlling night-time acid, a prevalent and unmet aspect of current PPI therapy of GERD. GERD is the most prevalent of the major gastrointestinal disorders and is most commonly treated with PPI drugs, which achieve global annual sales in excess of USUSD20 billion. Night-time acid breakthrough is estimated to occur in at least 50 per cent of GERD patients on PPI therapy. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastro-intestinal (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. About Axcan Pharma Axcan Pharma is a privately-held, leading specialty pharmaceutical company that develops and markets a wide range of products to treat gastrointestinal diseases and disorders, such as inflammatory bowel disease, cholestatic liver diseases, irritable bowel syndrome, and complications related to pancreatic insufficiency. Axcan's products are marketed by its own dedicated and specialized sales forces both in North America and the European Union. The company also markets its products in more than 40 countries through a global network of local partners. 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 END