RESEARCH TRIANGLE PARK – Drug giant GlaxoSmithKline earned two victories in the ongoing battle to treat AIDS, one involving a patent settlement and the other securing FDA approval for a longer-term HIV treatment from GSK-owned ViiV Healthcare.
First, the patent.
GSK (NYSE: GSK) disclosed Tuesday it had reached a patent settlement with rival Gilead in a dispute over technology used in an HIV drug. ViiV, GSK and ViiV part-owner Shionogi had charged Gilead’s HIV drug Biktarvy infringed ViiV patents.
Gilead agreed to pay a one-time fee of $1.25 billion in the first quarter of this year plus 3% royalties. The money will be divided among ViiV’s owners, which includes Pfizer.
“ViiV Healthcare, GSK and Shionogi alleged that Gilead’s Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir,” GSK said in a statement. “As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued.”
GSK maintains operations in RTP and Wendell.
ViiV has a substantial R&D operation in RTP.
The drug win
ViiV announced Tuesday that the FDA had approved its drug Cabenuva for use every two months to treat HIV.
“Cabenuva is now approved for administration as few as six times a year for virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine,” ViiV explained.
The treatment was approved for once-a-month use a year ago.
In a statement, Lynn Baxter, head of North America at ViiV Healthcare, noted: “ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that address the evolving needs of the HIV community. Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year.”
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