AbbVie Up on HCV Filing in Canada - Analyst Blog

AbbVie Inc.'s ABBV shares continue to inch up since the company announced its new drug submission (NDS) to Health Canada for its investigational hepatitis C virus (HCV) infection therapy. Shares were up 0.7% following the company's announcement. Overall shares increased 1.3% since the announcement.

AbbVie's oral investigational regimen comprises a fixed-dose combination of ABT-450/Norvir (150 mg/100 mg) co-formulated with ABT-267 (once daily) and ABT-333 with or without ribavirin (RBV), administered twice daily. The company is the looking to get the combination therapy approved for use in adults with chronic genotype 1 (GT 1) HCV infection.

The company is developing ABT-450 in collaboration with Enanta Pharmaceuticals ENTA. The investigational HCV therapy is also under FDA review for the same indication.

We note that on May 1, 2014, Health Canada granted priority review status to AbbVie's investigational direct-acting antiviral (DAA) regimen (with and without ribavirin) for the treatment of HCV GT 1. The designation should help expedite the review process for the candidate.

The candidate also has Breakthrough Therapy status in the U.S. AbbVie intends to commercialize the combination therapy in the U.S. in late 2014, if approved, and expects EU approval in early 2015.

We are pleased to see AbbVie working on strengthening its HCV pipeline. However, the market is highly crowded and is led by Gilead Sciences GILD. Gilead's Sovaldi (launched in Dec 2013) generated revenues of $2.27 billion in the first quarter of 2014. Moreover, the company is looking to get a combination therapy of ledipasvir and Sovaldi approved in the U.S. and EU.

Recently, Johnson & Johnson's JNJ Olysio received approval in the EU for the treatment of genotype 1 and 4 chronic HCV infection.

AbbVie carries a Zacks Rank #3 (Hold). Gilead is a better-ranked stock with a Zacks Rank #1 (Strong Buy).