July 30, 2012 | By John Carroll
It looks as if Gilead can’t be shamed into a late-stage hepatitis C collaboration with Bristol-Myers Squibb after all.
Despite taking heat for its refusal to commit to BMS ($BMY), Gilead ($GILD) has now mapped out a plan to get its own in-house combo into a late-stage study later this year. And it believes it has the goods to jump ahead, nailing down the pivotal data needed for a 2014 regulatory filing after a high-speed, forced march into the clinic.
A few weeks ago BMS CEO Lamberto Andreotti blasted Gilead for refusing to push ahead on a Phase III study combining Gilead’s GS-7977–purchased for a princely sum when the company bought out Pharmasset for $11 billion–with BMS’s daclatasvir after the oral treatment offered stellar results in a mid-stage study. Daclatasvir is an NS5a inhibitor and the combo produced high cure rates at 12 weeks for the genotype 2/3 as well as genotype 1 hep C groups. Not surprisingly, BMS–which acquired the nuc INX-189 in the $2.5 billion Inhibitex buyout– wanted to jump into a late-stage study with a combo that promised to swiftly move ahead as a new market leader. And experts in the field were left chomping at the bit.