AbbVie Inc. (ABBV) submitted a new drug application (:NDA) to the U.S. Food and Drug Administration (:FDA) for its investigational hepatitis C virus (:HCV) infection therapy. 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 (RB.V), administered twice daily. The company is the looking to get the combination therapy approved for use in adults with chronic genotype 1 (GT1) HCV infection
The company is developing ABT-450 in collaboration with Enanta Pharmaceuticals (ENTA). Enanta and AbbVie shares have risen 7.38% and 1.17%, respectively, on the news.
We note that the FDA had granted Breakthrough Therapy designation to AbbVie's HCV regimen with or without RBV in 2013. The designation should help expedite the review process for the candidate. AbbVie remains on track to file for its HCV treatment in the EU in early May.
We are encouraged by the pipeline progress at AbbVie. We believe that AbbVie’s investigational therapy has a good chance of gaining approval based on high rates of response and low discontinuation rates.
However, we note that HCV is a highly crowded market led by Gilead Sciences’ (GILD) drug Sovaldi, which reported whopping revenues of approximately $2.3 billion in the first quarter of 2014. This is impressive considering that it is the first full quarter for Sovaldi, which was launched in Dec 2013. Moreover, Gilead is seeking approval for its once-daily fixed-dose HCV cocktail treatment, ledipasvir plus Sovaldi.
Meanwhile, Bristol-Myers Squibb Company (BMY) is also looking to get its all-oral combination of daclatasvir and asunaprevir approved in the U.S. 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 #2 (Buy).