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AbbVie (ABBV) HCV Regimen Gets Priority Review in Canada

AbbVie Inc.ABBV announced that its New Drug Submission (NDS) for an investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) received priority review in Canada for the treatment of all major chronic hepatitis C virus (HCV) genotypes (genotypes 1-6). On a successful approval, the G/P regimen would provide patients with a shorter-duration treatment option.

Glecaprevir (GLE) is a potent protease inhibitor, while pibrentasvir (PIB) is a new NS5A inhibitor.

We remind investors that earlier this month, the European Medicines Agency (EMA) validated AbbBie's Marketing Authorisation Application for G/P. The combination is now under accelerated assessment for the treatment of all major chronic HCV genotypes.

Note that AbbVie submitted an New Drug Application for G/P in the U.S. in Dec 2016. The company is also on track to submit a regulatory application for the combination regimen in Japan this quarter.

Shares of AbbVie have outperformed the Zacks classified Large Cap Pharma industry in the last three months. The stock gained 8.9% during the period, while the industry increased 3.1%.

GLE was discovered under a collaboration agreement between AbbVie and Enanta Pharmaceuticals ENTA for HCV protease inhibitors.

Coming back to the latest news, the NDS in Canada was backed by data from eight registration studies in AbbVie's G/P clinical development program. These clinical studies were conducted on more than 2,300 patients across major HCV genotypes as well as on special populations across 27 countries, including 174 patients in Canada. Data from the studies showed that eight weeks of treatment with G/P achieved high SVR12 rates across all major genotypes of chronic HCV.

We note that in Sep 2016, the FDA granted Breakthrough Therapy designation to G/P for the treatment of HCV in patients who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including treatment with an NS5A inhibitor and/or protease inhibitor. Breakthrough Therapy status for the pan-genotypic regimen was granted on the basis of positive results from the phase II MAGELLAN-1 clinical study.

Note that AbbVie has a deep pipeline comprising several interesting late-stage candidates. Some of these candidates include elagolix (endometriosis and uterine fibroids), atrasentan (chronic kidney disease), veliparib (indications including triple-negative breast cancer and previously treated squamous non-small cell lung cancer (NSCLC)) and ABT-494 (rheumatoid arthritis, Crohn's disease and ulcerative colitis).

AbbVie Inc. Price

AbbVie Inc. Price | AbbVie Inc. Quote

Zacks Rank & Key Picks

AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics, Inc. ANIK and Enzo Biochem, Inc. ENZ . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Anika's earnings estimates increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price increased 2.2% year to date.

Enzo Biochem's loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.

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Enzo Biochem, Inc. (ENZ): Free Stock Analysis Report

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AbbVie Inc. (ABBV): Free Stock Analysis Report

Enanta Pharmaceuticals, Inc. (ENTA): Free Stock Analysis Report

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


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

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