AbbVie moves closer to Japan's crowded hep C field with priority review nod

AbbVie's Scott Brun

AbbVie's ($ABBV) used to heavy hep C competition thanks to combo drug Viekira Pak, which has squared off against Gilead's ($GILD) Harvoni in the U.S. But now, the Illinois drugmaker is one step closer to a hep C approval in Japan, where it'll be a whole different ballgame.

On Wednesday, AbbVie announced that its ombitasvir/paritaprevir/ritonavir treatment had nabbed a priority review tag from Japan's Ministry of Health, Labour and Welfare, a designation that'll help it speed down the regulatory pathway toward a quick approval, if all goes well for the drugmaker.

"This marks another important advancement in our HCV clinical development program as we aim to provide our HCV treatment to patients across the world," Scott Brun, company VP of pharma development, said in a statement.

That triad and dasabuvir make up Viekira in the U.S., a combo regimen that's gone head-to-head with rival cocktail Harvoni. The Abbott ($ABT) spinoff recently touched off a stateside pricing war by bringing payers into the fray, inking an exclusive agreement with PBM Express Scripts to provide the drug at a discount--and prompting Gilead to do the same with Express Scripts ($ESRX) nemesis CVS ($CVS) and others.

In Japan, though, it's Bristol-Myers Squibb's ($BMY) tandem--Daklinza (daclatasvir) plus Sunvepra (asunaprevir)--that'll be waiting for AbbVie if and when it does win Japan's green light. And Bristol has already had some time to establish that one-two punch on the market: It won Japan's favor back in July of last year.

That's not to say Gilead's out of the picture, either. Sovaldi--a Harvoni component that already holds the U.S. crown for the fastest trip to the blockbuster benchmark--got Japan's go-ahead late last month. And Johnson & Johnson's ($JNJ) Olysio is on the market there, too, though a trio of patient deaths prompted local health authorities to add a safety warning to the drug's label last year.

AbbVie, moving ever closer to what could be a huge patent cliff, will have to hope its new med can stand its ground in the country, where it says 1.5 million to 2 million people are currently living with the infection. It's counting on its hep C endeavors to pay off as biosimilar competition ramps up for Humira, the $11-billion-per-year behemoth whose U.S. IP shield expires in 2016.

- read AbbVie's release

Special Reports: The new drug approvals of 2014 - Harvoni - Viekira Pak