No matter how hard Bristol-Myers Squibb ($BMY) tried to shame Gilead into pursuing studies for a combination of its hep C drug daclatasvir and the newly approved Sovaldi (sofosbuvir), Gilead Sciences ($GILD) wouldn't budge. Gilead shrugged off critics and insisted on taking a somewhat longer route to pursue its own in-house combo. But with an approval for daclatasvir likely in the near term, Bristol-Myers is stepping up with a plan to go ahead and marry the two therapies in any case--ahead of Gilead's looming application for a combo with ledipasvir.
In "the potential approval of daclatasvir in Europe, the label should be expansive enough to use with sofosbuvir," Bristol-Myers CFO Charles Bancroft told Bloomberg at the JPMorgan conference. "Hopefully what we do in Europe, we can parlay some of that to here in the U.S."
It's easy to see why Bristol-Myers remains bullish about the combo.
Last April investigators went over the numbers for sofosbuvir and daclatasvir, which demonstrated that after 12 weeks the combo cleared 100% of the virus among 40 patients who had already failed the two leading therapies, Incivek and Victrelis. And there was solid proof that the combination worked among patients in the genotype 3 group, a sizable minority of the market in key regions of the world.
Investigators like Graham Cooke at Imperial College London say that sofosbuvir/ledipasvir looks like a clear winner in the large genotype 1 population, but G3 patients may be missing out on sofosbuvir/daclatasvir.
If Bristol-Myers gets its way, they may not miss out after all.
- here's the report from Bloomberg