AbbVie's HCV Combo Drug Mavyret Clinches Approval In Canada

AbbVie Inc. (NYSE:ABBV) announced that its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), Mavyret, has been approved of in Canada for treating chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).

It is important to note that the ribavirin-free Mavyret recently gained an approval in the United States and the EU. The combination medicine is under priority review in Japan for the same indication.

AbbVie’s shares have marginally outperformed the industry so far this year. The stock has rallied 11.5% compared with the broader industry’s increase of 9.8%.

The approval in Canada was backed by data from nine registration studies in AbbVie’s G/P clinical development program. The clinical trials were conducted on more than 2,300 patients across major HCV genotypes. Data from these studies showed that eight weeks of treatment with G/P achieved 97% cure rates across all major genotypes of chronic HCV.

Significantly, glecaprevir (GLE) is a potent protease inhibitor while pibrentasvir (PIB) is a new NS5A inhibitor. Glecaprevir was discovered under a collaboration agreement with Enanta Pharmaceuticals (NASDAQ:ENTA) for HCV protease inhibitors.

Per the company’s press release, three million Canadians are chronically infected with HCV. More than 10,000 new cases of hepatitis C were reported in 2012 with approximately 40% of patients estimated to be unaware of the disease. Also, while GT1 is the most common genotype in Canada, GT3 is the most difficult to treat and cure. Hence, the drug’s approval is expected to provide the company access to a market with huge potential.

We remind investors that Gilead Sciences, Inc. (NASDAQ:GILD) launched Epclusa, the first all-oral, pan-genotypic, single tablet regimen for treating adults with genotype 1-6 HCV infection in the United States and the EU last year. This could lend a strong competition to Mavyret.

To those not informed, Merck & Co., Inc. (NYSE:MRK) is also evaluating an all-oral triple combination therapy MK-3682B, a mix of MK-3682, grazoprevir and ruzasvir1, for treatment of chronic HCV genotype (GT) infection.

Pricing pressure in the HCV market is increasing. The company said that it experienced market share loss and price erosion due to competitive dynamics within the HCV arena. This downturn continues this year with Viekira (HCV treatment) sales expected to decline to $1 billion in 2017.

Zacks Rank

AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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