AbbVie (ABBV) presented positive data from a phase III study, TURQUOISE-II, on its investigational hepatitis C virus (HCV) regimen at the recently held International Liver Congress.
The results from the study were also published online in The New England Journal of Medicine.
The global, multi-center, randomized, open-label study evaluated the efficacy and safety of AbbVie’s regimen with ribavirin (RBV) in adult patients suffering from genotype 1 (GT1) chronic HCV infection with compensated liver cirrhosis, post 12 weeks or 24 weeks of treatment. The patients enrolled for the study were either treatment naive or treatment-experienced (failed previous treatment with pegylated interferon and RBV).
The results from the TURQUOISE-II study showed that GTI patients achieved high sustained virologic response (SVR) rates in the 12-week (91.8%) and 24-week (95.9%) treatment arms, respectively.
We note that AbbVie’s oral investigational regimen comprises a fixed-dose combination of ABT-450 co-formulated with ABT-267 (once daily) and ABT-333 with or without ribavirin (RBV), administered twice daily. The company is developing ABT-450 in collaboration with Enanta Pharmaceuticals (ENTA).
Abbvie also presented positive results from two other phase III studies, SAPPHIRE-I and SAPPHIRE-II. The results from both the studies showed that SVR rates of 96% were achieved in both SAPPHIRE-I (new to therapy) and SAPPHIRE-II (treatment-experienced with pegylated interferon and ribavirin) in adult patients with genotype 1 chronic HCV infection.
We are encouraged by the pipeline progress at AbbVie. We note that the U.S. Food and Drug administration (FDA) granted Breakthrough Therapy designation to AbbVie's HCV regimen with and without RBV in 2013. The designation should help expedite the review process for the candidate.
However, we note that HCV is a highly crowded market led by recently approved Gilead Sciences‘ (GILD) drug Sovaldi, which has blockbuster potential.
We believe that AbbVie’s investigational therapy has a good chance of gaining approval based on high rates of response and backed by low discontinuation rates. AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie’s strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira.
A better-ranked stock in the healthcare sector is Bristol-Myers Squibb Co. (BMY), carrying a Zacks Rank #2 (Buy).
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