Gilead’s hep C sales are already taking a beating. And now, data show it could have some stiff competition coming its way from an AbbVie rival to its newest product in the field.
Over the weekend, AbbVie announced that its next-gen, pan-genotypic hep C combo had come up big in three separate studies, with 97.5% of patients achieving a sustained viral response after eight weeks of treatment. Patients across each of the major genotypes saw high SVRs, too.
Now, AbbVie says it's on track to take those data to regulators, by the end of the year in the U.S. and by early next in the EU and Japan. And that could spell trouble for Gilead’s Epclusa, the pan-genotypic product that scored the FDA’s green light in June.
While Epclusa patients receive a 12-week therapy regimen, AbbVie’s cocktail has shown it works well in just eight weeks--a fact that’s “unlikely to help Gilead’s future share or pricing leverage,” Jefferies analyst Brian Abrahams wrote in a note to clients.
Another sales hurdle for its hep C portfolio is the last thing Gilead needs. Earlier this month, it reported earnings that showed the lineup was still plunging in the face of competition and payer discounting; sales for the franchise sank by 31% in Q3.
There is a bright side for Gilead, though, Abrahams notes. The Big Biotech still has combo med Harvoni--which boasts a shorter treatment time than Epclusa does--for genotype 1 patients, and in that space the company’s “entrenchment with physicians and payers still provides some advantage,” he wrote.
Meanwhile, an approval down the line could be big for AbbVie, whose patents on lead drug Humira are under attack. So far, the Illinois pharma’s hep C combo, Viekira Pak, hasn’t provided the firepower the company initially expected; it has struggled against Harvoni since it launched and, more recently, felt the heat from Merck & Co.'s relative newcomer Zepatier, AbbVie CEO Richard Gonzalez has acknowledged.