Chronab Omeprazole (AGI-010)
We are developing a modified release formulation of the proton pump inhibitor drug (PPI), omeprazole, based on our CHRONAB technology which we believe will be effective in treating NAB, a prevalent 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. NAB is estimated to occur in at least 50 per cent of GERD patients on PPI therapy.
In March 2006 we announced the preliminary outcome of a combined human pharmacokinetics and pharmacodynamics study in 16 healthy subjects designed to characterise the in-vivo drug release profile, pharmacokinetics and the intra-gastric pH profiles of three modified release formulations of omeprazole given as 40mg once-daily at bedtime for five consecutive days, compared to marketed omeprazole given as 20mg twice-daily morning and evening before meals. Data from the study demonstrated that while modified release characteristics were clearly achieved, the time-course of in-vivo release was markedly delayed resulting in peak drug exposure at 5-6am.
AGI entered into a co-development and license agreement with Axcan Pharma Inc. in September 2006 to jointly develop AGI-010 for North American markets. AGI is working closely with Axcan to progress this product through the current Phase II product optimisation. Once this optimisation is successfully completed, AGI and Axcan plan to submit a request for a meeting with the FDA to define and agree the final phase of development for this product.
