Shionogi-Viiv Healthcare to start regulatory filing of dolutegravir by year-end

Shionogi-ViiV Healthcare, a joint venture between Japan’s Shionogi (TYO: 4507) and ViiV Healthcare, a global company with a sole focus on HIV set up in 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE), said last week that the Phase III data required for initial regulatory filings of the investigational integrase inhibitor dolutegravir in adults infected with HIV are in house.

Data from the two Phase III studies in treatment-experienced patients (VIKING-3 and SAILING) have been received and will be the subject of future presentations at scientific meetings. Together with previously disclosed data from the SPRING-2 and SINGLE studies in treatment-naive patients, these additional study data support Shionogi-ViiV Healthcare’s plans to commence global regulatory submissions for dolutegravir before the end of 2012. Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.

Study details