Gilead beats Street, moves forward with own NS5A-nuc combo

Gilead Sciences Inc. (NASDAQ:GILD) reported 2Q12 financial results on Thursday that beat the Street's estimates and said it is moving forward with its own fixed-dose HCV NS5A-nuc combination instead of one it had tested in Phase II trials with Bristol-Myers Squibb Co. (NYSE:BMY). Gilead began a Phase I bioavailability study of a fixed-dose combination of GS-7977, a nucleotide analog HCV NS5B polymerase inhibitor, and GS-5885, an HCV NS5A inhibitor. If the Phase I data show adequate exposure of the compounds, Gilead plans to begin a Phase III trial next quarter in treatment-naive patients with HCV genotype 1 infection.

Gilead was evaluating GS-7977 in Phase II testing in combination with daclatasvir, an HCV NS5A inhibitor from Bristol-Myers. In April, the companies reported positive interim data and Bristol-Myers said it was interested in a Phase III collaboration. However, the pharma said at the time that "Gilead was not interested." On a conference call Thursday, Gilead said it believes daclatasvir and GS-5885 are "very similar" from a virological standpoint. GS-5885 is in Phase II testing for HCV, while GS-7977 is in Phase III testing (see BioCentury, July 2). ...