DUBLIN, IRELAND-- 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
- 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.''
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
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Davy Tel: +353 1 614 8761
Axcan Pharma Inc.
Isabelle Adjahi, Senior Director,
Tel: + 1 450-536-7696
Investor Relations and Communications
For further information please see www.agitherapeutics.com.