Gilead ($GILD) captured the spotlight this morning with some impressive clinical results for GS-7977, wowing analysts with the mega-blockbuster potential of a treatment that may well have the inside track in the hectic race to create the first all-oral combo treatment for hepatitis C.
In one study, the nucleotide inhibitor--or "nuke"--7977 in combination with ribavirin had suppressed signs of the virus in most patients four weeks after treatment. And in a separate combo study with Bristol-Myers Squibb's ($BMY) NS5A replication complex inhibitor daclatasvir, the paired treatment impressively wiped out the virus in most patients across a range of genotypes, according to an interim analysis of this closely-watched mid-stage study.
BMS reported that the combination of the two oral, once-daily drugs taken for 24 weeks achieved "a rapid and sustained viral response. Overall, 100% of patients with genotype 1, 2, or 3 HCV achieved viral load below the lower limit of quantification at week 4 on treatment. In the genotype 1 HCV treatment groups, 100% of patients achieved sustained virologic response through four weeks off-treatment (SVR4). In the genotypes 2 and 3 treatment groups, 91% (40/44) of patients achieved SVR4."
The data were presented at the annual meeting of the European Association for the Study of the Liver in Barcelona.
The data represent a validation of Gilead's controversial $10.8 billion buyout of Pharmasset, netting 7977 in the process. UBS analyst Matthew Roden said the new results put the company "in the driver's seat" in the charge toward a next-gen treatment for hepatitis C, according to a report in Dow Jones. And Gilead's shares jumped 15% on the news as analysts pondered the implication of a new treatment that could arrive on the market in late 2013 or 2014.
But despite the stellar data, Gilead and BMS aren't prepared to rush ahead into Phase III. According to Adam Feuerstein at TheStreet, Gilead's more interested in the commercial opportunity presented by a combo using their own NS5A treatment--even though the BMS drug presents a shorter path to the market.
"Given the strong SVR4 [early cure] data from the combo trial of daclatasvir (DCV) + GS-7977, and in the interest of advancing the science and for the benefit of patients, we were interested in a Phase III collaboration. Unfortunately Gilead was not interested," Bristol spokeswoman Cristi Barnett tells TheStreet.
Gilead spokeswoman Amy Flood says: "That's not the case. There are a number of new data sets at EASL and we need to evaluate and understand all of them. We're going to do that, and look at the best option or options for proceeding as quickly as possible to advance the best all-oral regimen."
Both Vertex ($VRTX) and Merck ($MRK) gained approvals for new hepatitis C drugs last year. But the clinical focus swiftly shifted to the potential of new drug cocktails that will control the virus without the need for interferon injections.
"There are a lot of encouraging data sets here at EASL, including for our own NS5A and non-nucleoside, to consider," Gilead's John McHutchison tells Dow Jones. "We're going to look at everything presented here and be scientific in our approach as we consider the best option for proceeding as quickly and efficiently toward a safe, simple, all-oral regimen."
ALSO: Gilead and BMS weren't the only companies to grab headlines at EASL. Boehringer Ingelheim has its own all-oral hep C treatment in the pipeline, and the company reports that its BI 201335 protease inhibitor and BI 207127 polymerase inhibitor combined with ribavirin achieved an 82% cure rate in a mid-stage study for the most common genotype. Among all patients the cure rate was 68%. Story