US pharmaceutical giant Gilead announced Wednesday that it has signed licensing deals with six generic drugmakers to produce and sell its HIV prevention medication, lenacapavir, in lower-income countries. The move comes after Gilead faced pressure to open the drug to a patent pool.
Lenacapavir, a highly effective antiretroviral drug, has been hailed as a potential game-changer in the fight against HIV. Early trials found it to be 100% effective in preventing HIV infection. With Wednesday’s announcement, generic companies will be able to manufacture a lower-cost version of the drug in 120 countries, subject to regulatory approvals.
Gilead CEO Daniel O’Day emphasized the company’s urgency in bringing on high-volume generic manufacturers to expedite the drug’s availability. In July, researchers estimated that lenacapavir, which can cost patients over $40,000 per year in several countries, could be made for as little as $40. The drug’s twice-yearly injection regimen offers a significant advantage over daily pill-based treatments.
The international health agency Unitaid welcomed Gilead’s announcement, expressing its readiness to invest in and collaborate on fast-tracking access to lenacapavir. Unitaid’s executive director, Philippe Duneton, emphasized the drug’s potential to dramatically turn the tide against HIV infections and the importance of ensuring global access for all those in need.
There were 1.3 million new HIV infections last year, and 39 million people are living with the virus, according to the World Health Organization. The licensees announced on Wednesday include companies in India and Pakistan. Gilead is initiating a series of regulatory filings by the end of this year and prioritizing registration in 18 high-incidence countries.
Liverpool University researcher Andrew Hill noted that if the drug were given to people at high risk of contracting HIV, it could effectively shut down HIV transmission.