Aurobindo, Cipla and Viatris to produce generic versions of ViiV HIV preventive

 Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers

- Announcement includes potential for large scale manufacturing on the continent of Africa

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, together with the Medicines Patent Pool (MPP) have today announced that 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 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.1,2 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.

Only seven months after the first regulatory approval of cabotegravir LA for PrEP in the world by the US Food and Drug Administration (FDA),3 ViiV Healthcare and MPP signed a voluntary licence 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.4,5 This licence 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 sublicence 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 has plans to manufacture in South Africa as well. 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 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.

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.

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