Viatris Among Three Companies Licensed To Make GSK/Pfizer-Backed Long Acting HIV Prevention Drug

ViiV Healthcare and Medicines Patent Pool (MPP) have signed sublicence agreements with Aurobindo Pharma, Cipla Limited, and Viatris Inc VTRS – through its subsidiary Mylan – to manufacture generic versions of cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP).
Aurobindo Pharma and Viatris will manufacture in India.
Cipla Limited will manufacture in India and plans to manufacture in South Africa too.
ViiV Healthcare is majority owned by GSK Plc GSK, with Pfizer Inc GSK and Shionogi as shareholders.
GSK said in a statement that approximately 1.5 million people acquired HIV worldwide in 2021, among whom 860,000 live in sub-Saharan Africa. While oral PrEP options are now available in many countries, access to cabotegravir LA for PrEP could significantly contribute to reducing HIV transmission by providing people with a choice in their HIV prevention options.
In July 2022, ViiV signed a new voluntary licensing agreement with the Medicines Patent Pool (MPP) for patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) for the least developed, low-income, lower-middle-income and Sub-Saharan African countries.
The agreement allowed selected generic manufacturers to develop, manufacture and supply generic versions of long-acting cabotegravir for PrEP, the first long-acting HIV prevention medicine, in 90 countries, subject to regulatory approvals.
In December 2021, the FDA approved ViiV Healthcare's Apretude, the first and only long-acting injectable pre-exposure prophylaxis option, to reduce the risk of sexually acquired HIV-1.
The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV and have a negative HIV-1 test before initiation.

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