UPDATED: With hep C approval app, AbbVie eyes franchise growth in Japan

SINGAPORE--Here's some expansion news for AbbVie's ($ABBV) hepatitis C franchise. The U.S.-based drugmaker has asked Japanese regulators to approve its antiviral cocktail, hoping to grab a piece of that market as it fights for share in the States.

AbbVie's application to the Japanese Ministry of Health, Labour and Welfare is based on a Phase III study dubbed GIFT-I, which focused on patients with genotype 1b chronic hepatitis C. The regimen tested was 12 weeks of a three-drug cocktail, including two direct-acting antivirals.

The three agents--paritaprevir, ritonavir and ombitasvir--delivered a 95% sustained virologic response rate, the study showed. AbbVie markets a similar cocktail, Viekira Pak, in the U.S.; that regimen also includes another med, dasabuvir.

The filing puts AbbVie behind Bristol-Myers Squibb ($BMY) as the first to market a next-gen hepatitis C treatment in Japan. The BMS combo--the NS5A inhibitor Daklinza (daclatasvir) and the NS3/4A protease inhibitor Sunvepra (asunaprevir)--has been on the market in Japan since last fall, though the company pulled the combination from consideration by the FDA.

Meanwhile, AbbVie has been duking it out in the U.S. with Gilead ($GILD), inking price-cut deals with payers in an attempt to capture a piece of the hot hep C market. Gilead's Solvaldi (sofosbuvir) soared to blockbuster status last year, and a follow-up combo joined it on the U.S. market last fall.

AbbVie's shares have slid since it announced its 2015 forecast. Analysts worry that price cuts and payer deals are cutting into Viekira Pak's long-term sales prospects, at a time when the company really needs to build up newer products. Humira, the anti-inflammatory drug that's by far AbbVie's best-seller, goes off patent at the end of 2016, and several biosimilar developers are hoping to get in on the action.

A Citi analyst recently said biosims will quickly take a major bite out of Humira's sales--more quickly than others have expected. Today, Robyn Karnauskas of Deutsche Bank countered that gloomy rating, saying that AbbVie's pipeline can more than make up for biosimilar erosion over the next several years.

- read the AbbVie release
- and a graphic on the estimated prevalence of HCV infection and the distribution of HCV genotypes across the world
- get the latest from Deutsche Bank

Editor's note: This story was updated with details on AbbVie's hepatitis C drugs and research, and competitive stance in the U.S.

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