NEAT was a phase III, randomized, open-label, parallel-group 48-week study that compared 908 BID and nelfinavir BID, both in combination with ABC and 3TC in 249 antiretroviral therapy-nave patients. The primary endpoint of the NEAT study was the proportion of subjects with vRNA <400 c/mL at 24 and 48 weeks. Interim 24-week data from NEAT were presented in September at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICACC) in San Diego, and 48-week data are being presented here today.
Once approved, GSK will market 908 and GSK and Vertex will co-promote it in the United States and key markets in Europe.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.
This press release may contain forward-looking statements, including that 48-week interim analysis of the NEAT and SOLO studies in GlaxoSmithKline's pivotal program for 908 is indicative of a promising clinical and commercial outlook for 908, once approved. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. These risks and uncertainties include, among other things, the risk that approval will be delayed or will not be obtained, that 908 will not be commercially successful, and those other risks listed under Risk Factors in Vertex's form 10-K filed with the Securities and Exchange Commission on April 1, 2002.