AbbVie Inc. (ABBV) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (:HCV) infection therapy at the Retroviruses and Opportunistic Infections (:CROI) press conference. 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 global, multi-center, randomized, double-blind, placebo-controlled PEARL-III study (n = 419) evaluated the efficacy and safety of AbbVie's cocktail therapy in treatment-naïve non-cirrhotic chronic genotype 1b HCV infection patients for 12 weeks.
The study met its primary endpoints. Sustained virologic response rates after 12 weeks of treatment (SVR12) were 99.5% and 99% with and without RBV, respectively. Additionally, there were no discontinuations due to adverse events associated with the combination therapy.
AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014. We note that the U.S. Food and Drug administration (:FDA) has granted Breakthrough Therapy designation to AbbVie's HCV regimen with and without RBV. The designation should help expedite the review process for the candidate. The company believes that its HCV combination therapy can clinch an approval from the regulatory body this year itself.
AbbVie has partnered with Enanta Pharmaceuticals, Inc. (ENTA). Enanta shares have risen 19.1% since AbbVie initially presented data from four studies including PEARL-III in January.
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.
However, we note that several companies are in the race to launch their first all-oral treatment regime (without interferon injection) for HCV patients with genotype 1 infection in the U.S. Gilead Sciences Inc. (GILD) is looking to get its once-daily fixed-dose HCV cocktail treatment, ledipasvir plus Sovaldi, approved in the U.S. The company has already submitted the marketing application to the FDA. Meanwhile, Bristol-Myers Squibb Company (BMY) is not far behind with the FDA granting Breakthrough Therapy designation to its all-oral combination of daclatasvir and asunaprevir. We believe that apart from efficacy and safety, dosing and pricing will play crucial roles in determining the winner.
AbbVie currently carries a Zacks Rank #3 (Hold). Gilead is a better-ranked stock with a Zacks Rank #1 (Strong Buy).
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