Gilead Sciences is licensing its newest HIV drug candidate, bictegravir, to the U.N.-backed Medicines Patent Pool, meaning it will be produced and sold at a lower cost in 116 low- and middle-income countries once it is approved.
Gilead said it will include the HIV-1 candidate in its existing agreements with generic drugmakers Sun Pharmaceutical Industries, Strides Shasun, Mylan and SeQuent Scientific, as a single agent or in fixed-dose combinations with other HIV medicines, “upon regulatory approval” in the U.S. It also will allow the MPP to sub-license it to other generic producers in India, China and South Africa.
“Competition among manufacturers has reduced the lowest price of a Gilead HIV generic therapy by 80 percent since 2006, to as low as $3.50 per patient per month. Ninety-nine percent of people taking Gilead’s HIV therapies in developing countries receive generic medicine,” Gilead said in an announcement today.
Of course, it is the branded version in the U.S. and Europe, where drug approvals are currently pending, that Gilead is most interested in and where it will compete with GlaxoSmithKline’s $1.2 billion seller Tivicay (dolutegravir). The FDA has set a Feb.12, 2018 target date for consideration.
Analysts initially believed bictegravir, if approved, was going to be a red-hot competitor to the GSK med but phase 3 data released last spring cooled those expectations somewhat. While four studies of the investigational integrase strand transfer inhibitor hit their primary endpoints by measuring up to Tivicay and other antiretroviral agents, they didn’t prove that bictegravir is superior. Then in data released today, it reported the same finding at 48 weeks.
GSK, which has been aggressively building its HIV focused ViiV Healthcare, is taking another tack in its assault on market leader Gilead’s $10 billion-plus HIV franchise. The U.K.-based company is betting on a two-drug, dolutegravir-containing regimen that could potentially cut down on the side-effect burden of Gilead’s three-drug approaches, and their cost, too.