Gilead's Biktarvy Approval Heightens HIV Competition With ViiV
Gilead hopes Biktarvy will enable it to win market share away from ViiV's dolutegravir-containing regimens, but ViiV filed a patent infringement case within hours of the US FDA approval of Gilead's new combo.
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The company said in its fourth quarter earnings report that it would not seek accelerated approval for the drug, while it also settled an HIV drug-related intellectual property lawsuit with GSK/ViiV.
HIV remains the main growth franchise for Gilead, despite an anticipated first quarter revenue downturn due to inventory and payer mix. Biktarvy’s launch and growth in PrEP business provide multiple drivers for the franchise.
Gilead projects roughly $200m in sales growth for its CAR-T product Yescarta, despite the drug’s modest $6m sequential growth during the fourth quarter. For 2019 overall sales, the company projects slight growth, if any.