AGI Therapeutics plc, a speciality pharmaceutical development company, announced that its co-development/co-fund and licensing agreement for AGI-010 with Axcan Pharma Inc, 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; and greater night-time control of acidity compared to Prilosec.
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."'