Gilead Sciences, a US biopharmaceuticals company, announced on Wednesday that it had signed voluntary licensing pacts with six drug makers, including three in India, to sell and produce an anti-HIV medication called lenacapavir for primarily low- and lower-middle-income countries.
The non-exclusive, royalty-free agreements will enable Dr Reddy’s Laboratories, Emcure and Hetero in India, Eva Pharma in Egypt, Ferozsons Laboratories in Pakistan, and Mylan in the US to manufacture and supply lenacapavir to 120 resource-limited countries.
Public health advocates expect generic versions of lenacapavir to cost much lower than Gilead’s price reported to be $42,250.
Sections of public health experts have described lenacapavir as a medicine that promises to “end AIDS”. Clinical trials have demonstrated that lenacapavir — a twice-yearly injection — has superior efficacy over standard oral preventive medicines.
UNAIDS, a UN agency, had in July, citing clinical trial results, said the new drug “provides hope of accelerating efforts to end AIDS… but only if Gilead ensures that all people who need it can have access to this game-changing medicine”.
Gilead has said its agreements with the six companies advance its strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis globally if it is approved, and align with its “vision of ending the HIV epidemic for everyone, everywhere”.
Pre-exposure prophylaxis is a treatment intended to prevent a likely infection in the future.
“Gilead teams have been working with urgency to bring on high volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir is approved for pre-exposurse prophylaxis,” Daniel O’Day, Gilead’s chief executive officer, said in a media release.
The company said it had selected the six partners based on rigorous criteria, given the challenges of manufacturing lenacapavir.