AbbVie Up on HCV Filing in Canada - Analyst Blog

By Zacks Equity Research,

Shutterstock photo

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).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

ABBVIE INC (ABBV): Free Stock Analysis Report

ENANTA PHARMA (ENTA): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

JOHNSON & JOHNS (JNJ): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
Referenced Stocks: ABBV , ENTA , GILD , JNJ

More from


Follow on:

Find a Credit Card

Select a credit card product by:
Select an offer:
Data Provided by