Looking to carve away market share from Gilead, ViiV and J&J score positive PhIII data for a monthly, 2-drug HIV injectable

ViiV Healthcare’s future depends on its ability to carve away market share from the blockbuster combination drugs that Gilead uses to dominate the HIV market. And they took another step toward that future today with a set of headline results pointing to the success of a once-monthly injectable in keeping the virus at bay in a big Phase III study — matching up nicely with a standard daily three-drug oral combo.

John Pottage

ViiV, majority-owned by GlaxoSmithKline, is allied with J&J on this ATLAS study reading out today. Their long-acting injectable of the experimental cabotegravir and rilpivirine (J&J’s Edurant) underscored its potential as a substitute for the daily triplet, demonstrating an ability to suppress the virus in patients who were already being treated properly with the combo. And detailed results will be made available at an upcoming conference.

“If approved, this regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12,” noted ViiV chief scientist John Pottage.

ViiV’s strategy has been to pursue simpler drug regimens for HIV, offering a chance to manage costs and perhaps keep patients on the same regimen for longer periods. The company — shared with partners — has become a key part of GSK’s plans to develop new products while looking for a long-awaited turnaround in a struggling pharma group.

That’s no easy task, though, as Gilead has long presided as the big dog in HIV, demonstrating its own R&D savvy with the recent approval of the 3-drug combo for Biktarvy.

ViiV still has a long way to go here, with work underway on two more Phase III trials — FLAIR as well as ATLAS-2M, which will test their two-drug injectable in doses every 8 weeks against a standard option.

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