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AGI Terminates Agreement With Axcan For Omeprazole

Omeprazole, for the treatment of gastro esophageal reflux disorder

AGI Therapeutic (AGI) has reported that its co development/co-fund and licensing agreement with Axcan, for AGI-010, has been terminated by mutual consent.

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).

Reportedly, AGI now regains full control of AGI-010 and neither party has any outstanding or future obligations to the other.

Earlier, 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. Both the parties have worked together since then to develop and optimise the formulation and conduct human clinical testing.

Recently, AGI met with FDA who confirmed that AGI-010 can be registered in the US under the NDA 505(b)2 regulatory pathway.

John Devane, CEO of AGI, 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.”