Aurobindo, Cipla, Viatris to ink pact with MPP to make ViiV's HIV preventive therapy

ViiV Healthcare, a joint venture of GSK, Pfizer, and Shionogi, and the UN's Medicine Patent Pool (MPP) granted Aurobindo, Cipla, and Viatris sub-licenses to manufacture generic versions of the 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 make HIV prevention medication available to millions of people living in high-risk areas.

The three generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP in 90 countries under the MPP-ViiV Healthcare agreement, subject to regulatory approvals. Aurobindo and Viatris will manufacture in India; Cipla will manufacture in India as well as in South Africa. The three manufacturers were chosen through an open call for expressions of interest (EoI), which included a blinded review of applications and an on-site technical evaluation of short-listed applicants to identify manufacturers with proven technical expertise, capacity, and readiness (in terms of specialist manufacturing equipment) to develop long-acting nano-suspension-based injectable formulations.

Cabotegravir LA for PrEP is more difficult to manufacture than oral HIV prevention options, according to ViiV Healthcare, who stated that it is committed to assisting Aurobindo, Cipla, and Viatris with technical know-how. In December 2021, the USFDA approved cabotegravir LA for pre-exposure prophylaxis (PrEP). ViiV Healthcare and MPP signed a voluntary licence agreement for cabotegravir LA patents in July last year 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 alter the course of HIV." "ViiV Healthcare CEO Deborah Waterhouse stated. ""We are committed to working as quickly as possible with MPP and the selected generic manufacturers to 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.