• 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

Geneva and London – 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 between ViiV Healthcare and 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.

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 (WHO) with AVAC as the Secretariat – to 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 Viatris – through their respective sublicence agreement with MPP – will 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.”

Dr 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 making long-acting PrEP options equitably accessible as quickly as possible.”

Cabotegravir LA for PrEP is the first and only long-acting injectable antiretroviral (ARV) for which ViiV Healthcare has gained regulatory approval 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. Individuals must have a negative HIV-1 test prior to receiving it. ViiV Healthcare has submitted marketing applications in a number of countries including the majority of countries where clinical trials were conducted, with further registrations planned.

Mr. K. Nithyananda Reddy, Vice Chairman & Managing Director, Aurobindo, said: “We are excited that we have been granted the voluntary license from MPP to develop, manufacture & distribute generic Cabotegravir Tablets & Long Acting Injectables in select markets. This is the first time a longer acting injectable product for prevention of human immunodeficiency virus (HIV) infection will be made available in the LMIC, through this license. This product will be a good addition to Aurobindo’s ARV portfolio and will further strengthen our leadership in the generic HIV medicine space. We are looking forward to start supplying the product at the earliest and to help reducing the risk of HIV type 1 (HIV-1) infection in certain adults and adolescents weighing at least 35kg.”

Paul Miller, CEO of Cipla South Africa, said: “With the introduction of equitable access to cabotegravir long-acting for PrEP, there is an opportunity to end the HIV pandemic. This affordable new health technology helps to reduces the daily pill burden and increases confidentiality, meaning it has the potential to be truly transformative. Cipla has plans to manufacture in India as well as in South Africa.”

Arvind Kanda, Viatris, Head of ARV/API South Africa and Sub-Saharan Africa, said: “Viatris’ sub-license agreement with MPP for long-acting HIV pre-exposure prophylaxis (PrEP) is further evidence of our mission to empower people worldwide to live healthier at every stage of life. By working to expand access to this innovative form of PrEP we seek to contribute to the goal of ending HIV transmission, by offering a new option for long-lasting prevention.”

Access the sublicence agreements

The press release is also available in French and Spanish (translations by MPP)

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About cabotegravir extended-release injectable suspension

Cabotegravir LA for HIV prevention is the first and only long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition.

Cabotegravir LA for PrEP is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.

Cabotegravir LA for PrEP 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.

Please see full US Prescribing Information for Apretude.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Risk factors” in the company’s Annual Report on Form 20-F for 2022, GSK’s Q4 Results for 2022 and any impacts of the COVID-19 pandemic.

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References

[1] UNAIDS. Global HIV & AIDS statistics — Fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet Last accessed March 2023.

[2] UNAIDS. Fact sheet 2022.

[3] US Food & Drug Administration. FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention Last accessed March 2023.

[4] The World Bank. Country classification. Available at: https://data.worldbank.org/country Last accessed March 2023.

[5] United Nations. LDCs at a Glance. Available at: https://www.un.org/development/desa/dpad/least-developed-country-category/ldcs-at-a-glance.html Last accessed March 2023.