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AbbVie (ABBV) HCV Regimen Gets Priority Review in Canada
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AbbVie Inc. (ABBV - Free Report) 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 - Free Report) 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).
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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AbbVie (ABBV) HCV Regimen Gets Priority Review in Canada
AbbVie Inc. (ABBV - Free Report) 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 - Free Report) 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 - Free Report) and Enzo Biochem, Inc. (ENZ - Free Report) . 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%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>