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Gilead 's experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday. The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. If those results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025. RBC Capital Markets analyst Brian Abrahams expects Gilead's shot will significantly increase the number of people interested in preventive HIV medicine. In its statement disclosing the lenacapavir trial results Thursday, Gilead said it plans to share an update on how it plans to address access in such countries where people suffer high incidence rates of HIV.
Persons: Gilead, Jared Baeten, Gilead's Truvada, Bruce Richman, Tim Oliver, they'd, Brian Abrahams, Gilead's, — CNBC's Leanne Miller Organizations: Food and Drug Administration, PrEP, Centers for Disease Control, Prevention, Health, FDA, RBC Capital Locations: U.S, New York
Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it. The government received four patents for HIV prevention drug regimens that CDC researchers invented. Its lawsuit claims the patents also cover Gilead's pre-exposure prophylaxis (PrEP) drug regimen for lowering HIV infection risk. The U.S. Food and Drug Administration approved Gilead's Truvada for HIV prevention in 2012 and approved its related drug Descovy for the same purpose in 2019. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.
The U.S. is trying to enforce four patents issued to the Centers for Disease Control and Prevention on a two-drug regimen known as pre-exposure prophylaxis, or PrEP for short. The government accuses Gilead of reaping billions of dollars in PrEP sales without paying royalties to the CDC. Gilead has rejected U.S. allegations that the company's sales of its PrEP oral medications, Truvada and Descovy, infringe on any CDC patents. "Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC." Gilead rejects CDC claims that agency scientists developed the the PrEP regimen.
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