GSK has started a registration bioequivalence study for the new formulation – an orally disintegrating tablet formulation of an undisclosed compound – triggering the payment.
“We are delighted with how well this new formulation is progressing for GlaxoSmithKline,” said Gearoid Faherty, CEO of Eurand. “Using our Microcaps and AdvaTab technologies, we develop fast dissolving dosage forms that make it easier for patients to take their medicine. The new formulation for GlaxoSmithKline dissolves in the mouth in approximately 30 seconds without water and without leaving a bitter or sour taste.”
GSK intends to file for marketing authorization in the US by the end of 2007.