AbbVie nears launch of Viekira into crowded Japan HCV battle

Japan will see the next entrant in a fierce hepatitis C battle later this year with AbbVie ($ABBV) set to launch, putting Gilead Sciences ($GILD) and Bristol-Myers Squibb ($BMY) on the spot to hold sales in the key Asian reimbursement market.

AbbVie CEO Richard Gonzalez

In September, AbbVie received approval in Japan for Viekira Pak, the oral interferon- and ribavirin-free combination therapy for hepatitis C, and on the Oct. 30 earnings call, Chairman and CEO Rick Gonzalez and his executive team laid out some of the plans for that market.

"We also recently received regulatory approval for our two-pill, once-daily HCV therapy in Japan," Gonzalez said on the call. "We expect to receive reimbursement and launch in Japan in the next month or so."

Bill Chase, executive vice president and chief financial officer, filled in some details on sales of Viekira and how international performed as well as detail on the Japan timeline.

"Global Viekira sales in the third quarter were $469 million. The international launch has continued to exceed our planning expectations and has resulted in a higher mix of international sales this year," Chase said.

"As Rick mentioned, we recently received regulatory approval in Japan for our two-drug, once-daily ribavirin-free combination for the treatment of genotype 1b. We anticipate launching in Japan next month following the traditional 60-day reimbursement review cycle."

In the second-quarter call, Gonzalez said Viekira has won approval in 47 markets with more expected into 2016. In the third quarter, his comments came after Gilead and BMS released detailed figures for Japan sales with Gilead on the upswing and BMS taking it on the chin.

Gilead also detailed aggressive expansion plans abroad in the HCV space.

But Gonzalez, in a detailed presentation, said the company also had plans abroad that will show on the bottom line next year.

"Specifically for HCV, I'd say HCV will have some growth built into it year-over-year, because just of the gating of how the countries have rolled out over time internationally, you're going to get year-over-year. We're just launching in Japan now--well, we're not launching, we will be launching shortly in Japan now," he said.

"And Japan's a significant opportunity for us so it will create a year-over-year growth driver for us as well. So, I'd say there is growth built into the HCV franchise."

- here's the release and strategic objectives from AbbVie