ViiV Healthcare, jointly owned by GSK, Pfizer and Shionogi together with the UN’s Medicine Patent Pool (MPP) on Thursday issued sub-licenses to Aurobindo, Cipla and Viatris to manufacture generic versions of HIV preventive therapy cabotegravir long-acting injection for (pre-exposure prophylaxis (PrEP) for 90 low and middle income countries (LMICs) including India.

The licences will enable millions of people living in areas most impacted by HIV to access the preventive medication.

Through the MPP-ViiV Healthcare agreement, the three 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; Cipla will manufacture in India and has plans to manufacture in South Africa as well.

The three manufacturers were selected through an open call for expressions of interest (EoI), 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, ViiV Healthcare said it is committed to supporting Aurobindo, Cipla and Viatris with technical know-how to enable

The USFDA approved cabotegravir LA for pre-exposure prophylaxis (PrEP) in December 2021. In July last year ViiV Healthcare and MPP signed a voluntary licence agreement for patents relating to cabotegravir LA to help enable access in all least developed, low-income, lower-middle-income and sub-Saharan African countries.“Cabotegravir LA for PrEP has the potential to change the trajectory of HIV,” said Deborah Waterhouse, CEO at ViiV Healthcare.

“We are committed to working together with MPP and the selected generic manufacturers at pace to help enable development, manufacturing, and supply,” Waterhouse said.

MPP, ViiV Healthcare and generic manufacturers, will work with the Coalition to Accelerate Access to Long-Acting PrEP – convened by the Global Fund, PEPFAR, UNAIDS, Unitaid, and the WHO with AIDS Vaccine Advocacy Coalition (AVAC) as the Secretariat – to find solutions to accelerate rapid and sustainable access to cabotegravir LA for PrEP in LMICs.

“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,” said K. Nithyananda Reddy, vice chairman & managing director of Aurobindo.

Paul Miller, CEO of Cipla South Africa, said 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 reduce the daily pill burden,” Miller added.