New license agreement enables production of an innovative HIV prophylactic medicine for high-risk groups

In 2021, there were 4,000 new HIV infections per day, resulting in 38.4million people living with HIV globally. A recent voluntary license agreement between ViiV Healthcare and the Medicines Patent Pool (MPP), a UN-backed non-for-profit organization of which WIPO is a board member, will enable access to a generic formulation of cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) ─ a medicine that contributes to HIV prevention.

The licensing agreement allows drug manufacturers to produce a long-acting HIV PrEP medicine, for sale in developing countries. (Photo: iStock / nito100)

HIV was identified as the cause of AIDS in 1983. Although an effective HIV vaccine remains elusive, research efforts over the past 35 years have produced a range of prophylactic drugs, such as PrEP, to reduce the spread of HIV.

The pharmaceutical company ViiV Healthcare and MPP sealed a licensing deal in late July 2022, through which manufacturers selected by MPP will have the opportunity to develop and supply generic versions of cabotegravir LA for HIV PrEP to 90 least developed, low-income, lower-middle-income, and Sub-Saharan African countries.

The World Health Organization (WHO) affirms that cabotegravir LA for HIV PrEP is a highly effective prevention product administered by injection for people at risk of HIV infection. Cabotegravir LA for PrEP recently gained regulatory approval pdf in the USA for use among at-risk populations and is pending approval in countries where clinical trials for the drug were conducted. These include: Australia, Bostwana, Brazil, Kenya, Malawi, South Africa, Uganda and Zimbabwe.

“I am proud that through our long-standing partnership with MPP, we continue to play our part in widening access for people in resource-limited countries to new innovative medicines,” says Deborah Waterhouse, CEO of ViiV Healthcare in an MPP press release, noting that the partnership with the MPP will help prevent HIV transmission, especially among women and adolescent girls.

“This licensee was negotiated in double-quick time and is another example of MPP’s continued commitment to making innovation available and affordable in low- and middle-income countries in the shortest possible time. Rapid access to new technologies is our only hope of hitting the Sustainable Development Goal targets,” explains Charles Gore, Executive Director of MPP.

The MPP has already signed agreements with 15 patent holders for 13 HIV antiretroviral drugs.

About Medicines Patent Pool

The Medicines Patent Pool (MPP) solicits voluntary licenses from patent holders and manufacturers of antiretroviral medicines to create a pooled resource. Drug manufacturers, can then access the rights to develop formulations required for sale in developing countries.

The MPP has the potential to promote innovation and access to health products and medical devices, helping to save and improve the lives of millions of people living with diseases such as HIV, hepatitis C or COVID-19 treatments.

Through the creation of patent pools and the pooling of complementary patents, the efficient production of goods and services can be facilitated and the necessary inputs put in the hands of the most efficient and skilled producers.

Read more about how the MPP can help managing the intellectual property (IP) associated with HIV medicines to ensure people in developing countries benefit from innovations in HIV treatment.  

Video: The MPP is working to improve access to HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries.

About ViiV Healthcare

Establish in 2009 by GSK and Pfizer, with Shionogi joining in 2012, Viiv Healthcare is a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV and for people at risk of becoming infected with the virus. “At ViiV Healthcare we are determined to help end the HIV epidemic,” notes the company’s website.