(Bloomberg) -- Gilead Sciences Inc. said it is licensing its twice-yearly experimental HIV prevention drug lenacapavir to six generics makers after coming under fire from HIV advocates who argued the company was prioritizing profit over patients.
Gilead’s new deal would allow generics companies in India, Pakistan and elsewhere to produce a low-cost version of the powerful prevention regimen in 120 low- and middle-income countries upon the regulatory approval.
Gilead’s lenacapavir is looking like a powerful new prevention option for HIV after two successful trials announced earlier this year. In one trial in men and transgender people, just two of more than 2,000 people who received Gilead’s drug contracted HIV. In an earlier trial in women and adolescent girls in Africa, the shot prevented 100% of HIV cases.
The drug has yet to be approved for prevention, but the impressive results have put immense pressure on Gilead to quickly come up with a plan to get the drug to hard-hit countries that can’t afford to pay brand name drug prices. Recent academic research has found that generic versions of the prevention drug could be profitably produced for $40 a year.
“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now” so they can start making the drug after it’s approved, Gilead CEO Daniel O’Day said in a statement.
Gilead is planning to apply for regulatory approvals in some countries for lenacapavir for prevention by the end of the year. The drug is already approved as an HIV treatment under the brand name Sunlenca for people who have failed other treatments. Gilead said in its statement that the voluntary licensing agreements would offer the countries a lower-cost version of the drug for those with hard-to-treat HIV as well.
Ramping up manufacturing at the generic companies will take time. Gilead said in the statement it planned to prioritize getting approvals in 18 countries with higher rates of HIV including South Africa, Kenya, Nigeria, Thailand, and Vietnam.
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