The Medicines Patent Pool (MPP) has signed sublicence agreements with Aurobindo, Cipla and Viatris (through its subsidiary Mylan) to manufacture generic versions of cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP).

This was jointly announced by MPP and ViiV Healthcare, the global specialist HIV company, majority of which is owned by GSK, with Pfizer and Shionogi as shareholders. The latest development followed the signing of a voluntary licensing (VL) agreement for patents relating to cabotegravir LA for PrEP between ViiV Healthcare and MPP in July 2022, MPP said.

Through the MPP-ViiV Healthcare agreement, the selected generic manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to required regulatory approvals being obtained. Aurobindo and Viatris will manufacture in India; Cipla will manufacture in India and has plans to manufacture in South Africa as well, MPP said.

HIV prevention option

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 a choice in their HIV prevention options, according to UNAIDS

Seven months after the first regulatory approval of cabotegravir LA for PrEP in the world by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a VL agreement for its patents   to help enable access in all least developed sub-Saharan African countries.

This licence builds on a partnership between ViiV Healthcare and MPP, which has been successful in facilitating the manufacture and sale of generic versions of oral ViiV Healthcare medicines in countries most affected by HIV and least able to pay for treatment and care.

Selection process

The three manufacturers were selected through an open call for Expressions of Interest, which included a blinded assessment of applications and an on-site technical assessment of short-listed applicants with proven technical expertise, capacity, and readiness (in terms of specialist manufacturing equipment) to develop long-acting nano-suspension based injectable formulations.

Compared to 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 added.

Charles Gore, MPP Executive Director 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 LA for PrEP will contribute to broadening access to innovative long-acting prevention medicines in low- and middle-income countries.”

 Until a generic version is available, ViiV Healthcare is committed to continuing to work with partners to widen access and supply cabotegravir LA for PrEP at a non-profit price in low-income, least developed and all sub-Saharan African countries, the note said.

Cabotegravir LA for PrEP is the first and only long-acting injectable antiretroviral (ARV) for which ViiV Healthcare has regulatory approvals in the US, Australia, Zimbabwe, South Africa and Malawi for use in HIV prevention for at risk adults and adolescents weighing at least 35kg to reduce the risk of sexually acquired HIV-1 infection.

It is provided as an injection administered six times per year and is initiated with a single 600 mg (3-ml) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months. Cabotegravir oral tablets may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine, the note said.