Countries with millions of hepatitis C (HCV) cases could help leapfrog sales of a next-generation pan-genotype therapy under development by AbbVie ($ABBV), which faces heavy competition in the U.S. on approved therapy Viekira even as the product did well in the second quarter on a global basis.
Rick Gonzalez, chairman and CEO, said in response to an analyst question on a July 29 second-quarter earnings call that an earlier target of $3 billion for Viekira (dasabuvir, ombitasvir, paritaprevir and ritonavir) was unlikely to be met. He also said the newer therapy nearing the end of clinical trials could bring the figure back into play.
In January, AbbVie announced 6 global Phase III clinical studies for candidates ABT-493 and ABT-530 in HCV patients with genotypes 1-6 HCV infection.
"We are nearing the completion of our registrational studies for the next-generation pan-genotypic HCV combinations," Gonzalez said on the call.
"Based on the mid-stage data we have disclosed to date, we believe that our new HCV combination will be highly competitive. The data illustrates that this therapy can deliver cure rates approaching 100% across genotypes and we believe the majority of patients will be well served with an 8-week treatment option."
He added that Abbive expects "to see results from the pivotal studies in the second half and we remain on track for commercialization next year."
Viekira sales reached $419 million for the period, up 8.2% on an operational basis, driven by international business in developed markets with U.S. sales under pressure from competitors such as Merck ($MRK) and Gilead Sciences ($GILD).
That dynamic has led to the company eyeing the next generation therapy as key for overall HCV sales abroad with existing developed markets in Europe and Japan an obvious target. The company is also looking at the developing world, and China and India in particular, with millions of patients further down the road.
In the case of India, manufacturers through a license deal with Gilead aimed at 100 developing countries, have lower-cost access to cutting-edge HCV therapies, including pan-genotype Epclusa (sofosbuvir and velpatasvir), which has raised the prospect of a price-cutting war for earlier therapies.
China, however, has yet to approve a newer HCV therapy, though firms such as Gilead, Ascletis and Bristol Myers-Squibb ($BMY) are in the running there. But a pan-genotype approval going by the past regulatory timeline could be years away.
Still, Gonzalez suggested that as the HCV market transforms--the action will be international.
"We fundamentally believe that next generation will allow us an opportunity to be able to grow our share. If you look outside the United States, as an example, and you look in countries where there is predominantly a (genotype) 1b population, but even in some countries where there's a significant 1a population, our market shares in most of those countries are in I'd say on the low end 30%, on the high end sometimes as high as 70%," Gonzalez said.
"So we compete very well. And the profile of 1b is certainly much more of a competitive profile to the alternatives that are available outside the United States. And so I think it gives you an idea of our ability to be able to perform in those markets. So we would hope and, I think, expect that next generation will allow us to be able to gain a share in those marketplaces."
He added that in response to the question on whether an earlier $3 billion target for HCV sales holds would depend on getting the next-generation product out quickly into all markets.
"I think we anticipate that we would get back into that range, but I'm going out of the business of predicting HCV at this point."
Also on the call, Bill Chase, executive vice president and chief financial officer, gave some details on international sales of blockbuster Humira (adalimumab) for the second quarter.
"International Humira sales were more than $1.4 billion in the quarter, up 4% on an operational basis and exceeding our prior guidance of 3% operational growth for the quarter," Chase said, without breaking figures out by region.
"Internationally, Humira continues to maintain its strong market leadership position."
No comment was made on a European Marketing Authorization application review of a Humira biosimilar from Samsung Bioepis underway or on plans by India's Biocon to file abroad.
- here's the release
Humira's 17% leap fuels AbbVie Q2 beats
EMA to review Samsung Bioepis' Humira biosim application
AbbVie hangs tough on Humira international sales
AbbVie's Humira bails out Viekira to keep Q1 sales in line
Merck's 'aggressive' hep C pricing helps it steal share in Q1