Company is seeking new partner for controlled-released, once-daily version of omeprazole for these markets.
AGI Therapeutics and Axcan Pharma terminated their North American agreement for AGI’s Phase II candidate for gastro-esophageal reflux disorder (GERD), AGI-010. AGI has full control of this candidate and is looking for a new development partner in North American markets.
Neither AGI nor Axcan have any outstanding or future obligations under the original co-development and licensing agreement, which was signed in 2006. AGI’s CEO, John Devane, Ph.D., says the return of its North American rights is consistent with the company’s ongoing strategic review.
The FDA recently confirmed AGI-010 can be registered in the U.S. under the NDA 505(b)2 regulatory pathway. The drug is a modified-release, once-daily version of the proton pump inhibitor (PPI) drug omeprazole.
AG-010 has been formulated using the company’s controlled-release Chronab technology, which it believes will help prevent nocturnal acid breakthrough. The firms says that clinical trials have shown that in comparison with Prilosec® (omeprazole), the optimized formulation of AGI-010 matches AUC and overall 24-hour gastric pH as well as enables greater night-time control of acidity. AGI-010 also demonstrated an extended plasma level profile consistent with once-daily administration and a bimodal plasma level profile attained through its combination of delayed and controlled-release beads.
