Pharmaceutical giant agrees to license new HIV prevention drug to 120 countries – Euractiv

Pharmaceutical giant Gilead Sciences approved new licensing agreements for lenacapavir, an antiretroviral drug that offers near-complete protection against HIV infection.

The drug, packaged in the U.S. as Sunlenca (sold for $42,250 a year for two injections), could soon hit the market as a cheaper copycat drug in low- and lower-middle-income countries.

“Our focus is on making it available as quickly and widely as possible where the need is greatest,” said Daniel O'Day, Gilead's chairman and chief executive officer, in a statement Press release.

The company struck a licensing deal with six manufacturers in India, Egypt and Pakistan on Thursday (October 3), following calls from civil rights groups.

“Lenacapavir has the potential to change the course of the AIDS epidemic. WHO urges all manufacturers to ensure that this medicine is available and affordable in all countries. including where new HIV infections are increasing,” World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said in an X post/tweet on Friday.

The biannual injection provided 100% protection in the preliminary Phase 3 trial of over 5,000 women in South Africa and Uganda, indicating promising advances in HIV prevention through pre-exposure prophylaxis (PrEP).

Lenacapavir appears to be easier to use and more effective than oral PrEP. While PrEP is a preventative treatment for people at high risk of HIV that can be taken as a daily pill, lenacapavir is a twice-yearly injectable treatment.

This makes it more suitable for vulnerable groups such as sex workers, migrants, gay men, transgender people and drug users, who often face barriers to testing and treatment.

However, Gilead has not yet disclosed the specific cost of the nonprofit treatment.

researchers at University of Liverpool have said it could be produced for $40 a year, with a 30% profit margin – assuming 10 million people use it.

However, some activists and HIV activists praised the decision urged Gilead is expanding access to lenacapavir and improving licensing terms to ensure no one is left out of the deal.

South American countries, including Brazil, Argentina, Peru and Mexico, were excluded from the agreements despite being part of the drug's study populations. Gilead plans to sell lenacapavir at a higher price in these countries.

“Gilead's voluntary licensing agreement excludes most of South America, where the HIV epidemic is rapidly increasing, as well as countries in the Middle East, Eastern Europe and Central and Southeast Asia,” he said Leena Menghaney, South Asia director of the Doctors Without Borders access campaign.

According to the According to the UNAIDS AIDSinfo database, a quarter of all HIV infections occur in countries excluded from the licensing agreement.

“Also Gilead “Voluntary licensing agreements limit the number of raw material suppliers for generic lenacapavir,” Menghane said. Therefore, major HIV drug manufacturers in India, China, Argentina, Thailand and Brazil, which face patent barriers, will be unable to produce or sell the treatment at affordable prices.

[Edited by Rajnish Singh]