29 July 2022 - - UK-based ViiV Healthcare, the global specialist HIV company majority owned by British pharmaceutical company GSK (NYSE: GSK), with US-based Pfizer (NYSE: PFE) and Japan-based Shionogi (OTC: SGIOY) as shareholders, and the Medicines Patent Pool have signed a new voluntary licensing agreement for patents relating to cabotegravir long-acting for HIV pre-exposure prophylaxis to help enable access in least developed, low-income, lower middle-income and Sub-Saharan African countries, the company said.

Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP, the first long-acting HIV prevention medicine, in 90 countries, subject to required regulatory approvals being obtained.

It is expected that this agreement will help to enable at-scale access to generic cabotegravir LA for PrEP.

This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, by the US Food and Drug Administration (US FDA).

Each year, there are approximately 1.5 m new cases of HIV worldwide, most of which occur in resource-limited countries, with women and adolescent girls disproportionately impacted. While oral PrEP options are available in many countries, challenges with adherence and stigma have limited their impact in some populations.

Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.

The new voluntary 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.

In particular, voluntary licensing has enabled access to generic products containing another of ViiV Healthcare's innovative medicines, dolutegravir, for at least 20 m people living with HIV in low- and middle-income countries, as of December 20214.

This voluntary licence forms part of a holistic approach to enable at-scale access to cabotegravir LA for PrEP in least developed, low-income, lower middle-income and Sub-Saharan African countries.

There are complexities and considerations that need to be managed to support the manufacturing and roll out of a generic long-acting injectable.

Compared to oral PrEP options, cabotegravir LA for PrEP is more complex to manufacture and there is an evolving and less well-defined demand for the product.

These are challenges not only for ViiV but also for any potential generic partners.

ViiV Healthcare and MPP will now work closely with stakeholders and generic manufacturers selected through MPP's expression of interest to enable access to generic cabotegravir LA for PrEP as soon as possible.

Cabotegravir LA for PrEP is a long-acting injectable which has recently gained its first regulatory approval for use in HIV prevention in the USA for at risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of sexually acquired HIV-1 infection.

Individuals must have a negative HIV-1 test prior to receiving it. It is not currently approved for use in HIV prevention anywhere outside of the USA.

ViiV Healthcare has submitted marketing applications in a number of countries including the majority of countries where the clinical trials were conducted, with further registrations planned.

ViiV Healthcare is also working with stakeholders including global health agencies, non-governmental organisations, governments and community partners to understand country-specific contexts and is supporting implementation science projects that will provide critical information on the feasibility, acceptability and scalability to deliver successful introduction of cabotegravir LA for PrEP into national programmes.