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Aurobindo, Cipla, Vitaris to manufacture HIV PrEP generics

Through an agreement between the Medicines Patent Pool and ViiV Healthcare, the three generic manufacturers can develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries.

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, together with the Medicines Patent Pool, announced that MPP has signed sublicense agreements with Aurobindo, Cipla and Viatristhrough its subsidiary Mylan to manufacture generic versions of cabotegravir long-acting for HIV pre-exposure prophylaxis.

This is enabled by the signing of a voluntary licensing agreement for patents relating to cabotegravir LA for PrEP with MPP in July 2022.

According to UNAIDS’ latest estimates, approximately 1.5 million people acquired HIV worldwide in 2021, among whom 860,000 live in sub-Saharan Africa, with women and adolescent girls disproportionately impacted.

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.

[Read more: ViiV Healthcare, Medicines Patent Pool provide access to HIV prevention medications]

Only seven months after the first regulatory approval of cabotegravir LA for PrEP in the world by the Food and Drug Administration, ViiV Healthcare and MPP signed a voluntary license agreement in July 2022 for patents relating to cabotegravir LA for PrEP to help enable access in all least developed, low-income, lower-middle-income and sub-Saharan African countries.

This license builds on a long-standing partnership between ViiV Healthcare and MPP, which has been highly 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.

Deborah Waterhouse, CEO at ViiV Healthcare, said, “Cabotegravir LA for PrEP has the potential to change the trajectory of HIV. The signing of sublicense agreements with three generic partners is an incredibly important milestone towards enabling broad access to this medicine in countries where there is the highest burden of new HIV cases. We are committed to working together with MPP and the selected generic manufacturers at pace to help enable development, manufacturing and supply.”

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 plans to manufacture in South Africa. These 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 to enable the selection of manufacturers with proven technical expertise, capacity and readiness (in terms of specialist manufacturing equipment) to develop long-acting nano-suspension based injectable formulations.

[Read more: Walgreens, Greater Than AIDS work on free HIV testing]

Compared to oral HIV prevention options, cabotegravir LA for PrEP is more complex to manufacture. ViiV Healthcare is committed to supporting Aurobindo, Cipla and Viatris with technical know-how to enable development and access as soon as possible.

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 LA 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.”

MPP, the selected manufacturers and ViiV Healthcare, will continue to work with the Coalition to Accelerate Access to Long-Acting PrEP  convened by the Global Fund, PEPFAR, UNAIDS, Unitaid and the World Health Organization with AVAC as the Secretariatto find tangible, practical solutions to accelerate rapid and sustainable access to cabotegravir LA for PrEP 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.

Mitchell Warren, executive director of AVAC, said, “Cabotegravir LA for PrEP is a proven HIV prevention method that must be widely accessible to people who need and want to use it, and the signing of these sublicence agreements is an important step in the process to accelerate access and impact. Aurobindo, Cipla and Viatristhrough their respective sublicence agreement with MPPwill need to work closely with the Coalition to support access to this long-acting medicine in the years to come, and, hopefully, build a platform for future long-acting options as well.”

Philippe Duneton, executive director of Unitaid, said, “We are delighted that these generic manufacturers, through the selection process conducted by MPP, were able to demonstrate their capability to produce generic cabotegravir LA for PrEP and sign the first MPP agreements for a long-acting medicine. Unitaid is working with implementing partners to ensure optimal use as part of a PrEP package that enables choice, and with the Coalition and other international partners to make long-acting PrEP options equitably accessible as quickly as possible.”

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