AbbVie (ABBV) released positive results from a phase III study, SAPPHIRE-II, which evaluated three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (:HCV). Detailed data from the study will be released at forthcoming scientific meetings.
The global, multi-center, randomized, double-blind, placebo-controlled, 12-week SAPPHIRE-II study evaluated the safety and efficacy of ABT-333 (250mg) and ribavirin (weight-based) twice daily along with a single daily fixed-dose combination of ABT-267 (25mg) co-formulated with ABT-450/ritonavir (150/100mg). The company is developing ABT-450 in collaboration with Enanta Pharmaceuticals (ENTA). The study had enrolled 394 adults who failed previous treatment with pegylated interferon and ribavirin.
In the study, it was observed that 96% of treatment experienced patients achieved a sustained virologic response after 12 weeks of treatment. In addition, only 2% of patients suffered a virologic relapse.
We note that SAPPHIRE-II is the second of six phase III trials being conducted to evaluate the efficacy of the 3D regimen in GT1 HCV patients.
Last month the company released encouraging data from the SAPPHIRE-I study. In the 12-week, SAPPHIRE-I study, 96% of treatment naïve patients on the 3D regimen achieved a sustained virologic response.
AbbVie expects data from the remaining studies to be available in the coming months. The company remains on track for major regulatory submissions for the 3D regimen in the second quarter of 2014.
While AbbVie shares were up 1.8%, Enanta shares shot up 28.6% on the news. We are encouraged by the pipeline progress at AbbVie. However, we note that HCV is a highly crowded market with players like Gilead Sciences Inc. (GILD). Earlier this month, Gilead got a HCV drug, Sovaldi, approved in the U.S.
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.
Some better-ranked stocks include Bayer (BAYRY). The stock carries a Zacks Rank #2 (Buy).