MEDICINES PATENT POOL SIGNS SUBLICENCES WITH AUROBINDO, CIPLA AND VIATRIS TO PRODUCE GENERIC VERSIONS OF ViiV HEALTHCARE’S INNOVATIVE LONG-ACTING HIV PREVENTION MEDICINE
- 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
London, 30 March 2023 – 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.”
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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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- UNAIDS. Global HIV & AIDS statistics — Fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet Last accessed March 2023.
- UNAIDS. Fact sheet 2022. Available at: https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf Last accessed March 2023.
- 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.
- The World Bank. Country classification. Available at: https://data.worldbank.org/country Last accessed March 2023.
- 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.