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

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  • ViiV Healthcare and Medicines Patent Pool (MPP) have signed sublicence agreements with Aurobindo PharmaCipla 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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