ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, picked up FDA approval for a single pill that combines three antivirals and promises to challenge a leading treatment from Gilead Sciences.
Johnson & Johnson has signed a deal with ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, to spin their two antivirals into a single tablet, potentially sparing patients from some harsh side effects associated with current therapies and challenging Gilead Sciences' dominance in the field.
The approval marks another key advance for GSK on the regulatory front this year, providing a blockbuster candidate that analysts believe should do very well in competing against Gilead's rival therapies.
Based on the big promise of GlaxoSmithKline's dolutegravir, the FDA has granted the potential HIV drug a priority review of 6 months rather than the standard 10 months.
GSK and its minority partner Pfizer are each giving up a portion of their equity in Viiv Healthcare to Shionogi in exchange for a controlling interest in dolutegravir, a late-stage integrase inhibitor that has demonstrated success at barring HIV from penetrating cells.
GlaxoSmithKline ($GSK) has taken some bold steps to reconfigure its R&D operations, tackling some of the productivity issues that have plagued Big Pharma groups. Over the next year, the
ViiV Healthcare, a joint venture of GlaxoSmithKline and Pfizer, is touting potentially blockbuster comparative data for its experimental HIV drug dolutegravir. Researchers said that the treatment