GSK signs licence deals with three generics firms to make HIV preventative for low income countries
The three companies will make low-cost versions of HIV PrEP drug | Generics will be available to consumers in 90 low- and middle-income countries.
Three drug manufacturers have gained sublicenses to make generic versions of GSK’s Apretude (cabotegravir), which could significantly boost access to the long-acting HIV prevention medicine for millions of people living in areas most impacted by the disease.
The partnership was announced today (March 30) by GSK’s ViiV Healthcare, a specialist HIV company, and Medicines Patent Pool (MPP), a United Nations-backed public health organisation working to increase access to life-saving medicines in low- and middle-income countries.
Generic manufacturers Aurobindo, Cipla and Viatris will make lower-cost versions of the drug thanks to a voluntary license agreement signed in July last year by ViiV and MPP for patents relating to Apretude for HIV pre-exposure prophylaxis (PrEP).
They were selected through an open call for expressions of interest, which involved a blind assessment of applications and on-site technical assessment to ensure they had the ability to develop long-acting nano-suspension-based injectable formulations.
Now, the trio will be able to develop, manufacture and supply the Apretude generics in 90 countries, subject to regulatory approvals being obtained. All three firms plan to manufacture in India, with Cipla planning to make the drug in South Africa as well.
Charles Gore, executive director of MPP, said: “These three sublicence agreements are the first that MPP has signed for a long-acting medicine, and we are thrilled to be moving concretely into this space as these generic versions of cabotegravir long-acting for PrEP will contribute to broadening access to innovative long-acting prevention medicines in low- and middle-income countries.
“MPP is ready to support the selected generic manufacturers who can also count on our long-standing partner ViiV Healthcare to support the development process.”
Long-acting HIV prevention
Viiv Healthcare has regulatory approval for Apretude in the US, Australia, Zimbabwe, South Africa and Malawi for use in HIV prevention. It is provided as an injection that is given six times a year. Compared to oral HIV prevention options, it is more complex to manufacture, and Viiv has said it will support the three generic makers with the technical know-how to enable development.
However, it might be some time before the drug is available to people in the targeted countries, Fierce Pharma reported, with a ViiV spokesperson noting that under a prior licensing deal between GSK, MPP and Aurobindo, it was some three years before the first generic version of GSK’s oral HIV treatment Tivicay received regulatory approval.
Until a generic version is available, ViiV has said it will work with partners to widen access and supply Apretude at a non-profit price in low-income, least developed and all sub-Saharan African countries.
According to UNAIDS, around 1.5 million people acquired HIV in 2021, with 860,000 of those living in sub-Saharan Africa.
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