The United Nations-backed public health organisation Medicines Patent Pool has signed sublicense agreements with Aurobindo Pharma, Cipla and Viatris (through its subsidiary Mylan) under which the drugmakers will manufacture generic versions of ViiV Healthcare’s long-acting HIV prevention medicine cabotegravir LA.
The agreements have been enabled by the July 2022 voluntary licensing agreement for patents relating to cabotegravir LA for HIV pre-exposure prophylaxis (PrEP) between ViiV Healthcare and MPP. ViiV is majority owned by GSK and has Pfizer and Shionogi as shareholders.
The generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to regulatory approvals being obtained. Aurobindo and Viatris will manufacture in India, while Cipla will manufacture in India and has plans to manufacture in South Africa as well, MPP said in a statement.
Separately, in a release announcing signing of the voluntary sub-licensing for developing and marketing Cabotegravir tablets and long acting injectables, Aurobindo Pharma said it would utilise its vertically integrated capabilities to develop in-house active pharmaceutical ingredient (API) manufacturing, which will enable stronger control on supply chain and cost efficiencies.
The tablet and injectable dosage forms of the product will be produced at the APL Healthcare Unit IV, Naidupet, and at the new Eugia Sterile facility, Visakhapatnam, respectively. The company has adequate capacities of world class standards to meet the global demand for the product across the licensed territory, Aurobindo said.
MPP said compared with oral HIV prevention options, cabotegravir LA for PrEP is more complex to manufacture and ViiV Healthcare is committed to supporting Aurobindo, Cipla and Viatris with technical know-how to enable development and access as soon as possible. It said this citing UNAIDS’ latest estimates that about 1.5 million people acquired HIV worldwide in 2021, among whom 8,60,000 live in sub-Saharan Africa, with women and adolescent girls disproportionately impacted.
“We are committed to working together with MPP and the selected generic manufacturers at pace to help enable development, manufacturing, and supply,” ViiV Healthcare CEO Deborah Waterhouse said. Cabotegravir LA for PrEP is the first and only long-acting injectable antiretroviral for which ViiV Healthcare has got regulatory approval in the U.S., Australia, Zimbabwe, South Africa and Malawi for use in HIV prevention for at risk adults and adolescents weighing at least 35 kg to reduce the risk of sexually acquired HIV-1 infection, MPP said.
