Vertex Pharmaceuticals Incorporated announced that GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of GW433908 (also known as 908 or VX-175), an investigational HIV protease inhibitor in development for the treatment of HIV infection. GSK has simultaneously submitted a Marketing Authorization Application (MAA) for regulatory approval of 908 in the European Union. The 908 compound was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals.

The submissions for registration include data from more than 1,100 treatment-naïve and treatment-experienced patients who have participated in Phase III trials to evaluate the safety and efficacy of 908 in comparison with two widely used HIV protease inhibitors. In clinical trials, 908 was dosed as two tablets in both once-daily and twice-daily regimens.

"The regulatory submissions announced today represent a significant accomplishment for GSK and Vertex in 2002," said Joshua Boger, Chairman and CEO of Vertex. "Based on the data we have gathered in pivotal studies, we believe that 908 has the potential to be an important new option for the treatment of HIV, and one that is well-suited to the needs of today's HIV patients."

Once approved, GSK will market 908 and Vertex will co-promote in the U.S. and key markets in Europe. In connection with the regulatory filings announced today, Vertex earned a milestone payment from GlaxoSmithKline that will be realized in the fourth quarter of 2002.