The Medicines Patent Pool (MPP) has signed sublicense agreements with three major generic pharmaceutical manufacturers - Aurobindo, Cipla, and Viatris - to produce generic versions of cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP). The announcement represents a significant milestone in expanding access to the world's first long-acting injectable HIV prevention medicine.
Expanding Access to 90 Countries
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. Aurobindo and Viatris will manufacture in India, while Cipla will manufacture in India and has plans to manufacture in South Africa as well.
The sublicense agreements follow a voluntary licensing agreement signed between ViiV Healthcare and MPP in July 2022, just seven months after the US Food and Drug Administration's first regulatory approval of cabotegravir LA for PrEP worldwide.
Addressing Critical HIV Prevention Needs
According to UNAIDS' latest estimates, approximately 1.5 million people acquired HIV worldwide in 2021, with 860,000 living in sub-Saharan Africa. Women and adolescent girls are disproportionately impacted by the epidemic. While oral PrEP options are 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.
"Cabotegravir LA for PrEP has the potential to change the trajectory of HIV," said Deborah Waterhouse, CEO at ViiV Healthcare. "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."
Superior Efficacy and Convenient Dosing
Cabotegravir LA for PrEP is the first and only long-acting injectable antiretroviral for which ViiV Healthcare has gained regulatory approval in the US, Australia, Zimbabwe, South Africa and Malawi for use in HIV prevention. The medicine is proven superior to daily oral FTC/TDF in reducing HIV acquisition and is indicated for at-risk adults and adolescents weighing at least 35kg to reduce the risk of sexually acquired HIV-1 infection.
The treatment is provided as an injection administered six times per year, 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 tolerability.
Manufacturing Complexity and Technical Support
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. The selection process evaluated 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. ViiV Healthcare is committed to supporting Aurobindo, Cipla and Viatris with technical know-how to enable development and access as soon as possible.
"These three sublicense agreements are the first that MPP has signed for a long-acting medicine, and we are thrilled to be moving concretely into this space," said Charles Gore, Executive Director of MPP. "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."
Bridging Access Until Generic Availability
Until generic versions become 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 collaboration involves working 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 Secretariat, to find practical solutions for rapid and sustainable access in low- and middle-income countries.
Mitchell Warren, Executive Director of AVAC, emphasized the importance of the agreements: "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 sublicense agreements is an important step in the process to accelerate access and impact."
