GSK files new formulation application with FDA as per $42 million Eurand agreement

PHILADELPHIA GlaxoSmithKline has filed an application with the Food and Drug Administration for an orally disintegrating tablet formulation of a product co-developed with Eurand using its Microcaps taste-masking and AdvaTab technologies, according to CNN.

The companies had signed an agreement in October 2006, in which GSK would fund the development of a new product using Eurand’s technologies to develop a new formulation for the product. Under the agreement, GSK would have exclusive rights in the U.S. to commercialize the new product, and GSK and Eurand would each have certain rights to commercialize the product outside of the U.S. Eurand would retain exclusive, worldwide manufacturing rights. GSK would pay Eurand up to $42 million based upon achievement of certain development, regulatory and sales milestones.

GSK expects to launch the product in late 2008. Eurand is entitled to a milestone payment upon FDA acceptance for review of the application.

Gearoid Faherty, chief executive officer of Eurand, commented, "We are pleased that GSK continues to steadily progress this product towards commercialization and look forward to the anticipated launch in 2008."