AGI AGI

 

TIDMAGI 
 
RNS Number : 4279X 
AGI Therapeutics plc 
14 August 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 US$20 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 
 
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