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29 July 2022Big PharmaStaff writer

ViiV Healthcare signs deal to boost HIV drug access

Pharma firm joins with patent pool to expand access to HIV treatment | 90 countries set to benefit from preventative medicine

The  Medicines Patent Pool (MPP) and  ViiV Healthcare—specialist in HIV care that is majority-owned by  GSK, with  Pfizer and  Shionogi as shareholders—have united to help expand access to a HIV prevention medicine.

In an announcement shared yesterday, July 28, MPP said that ViiV had signed a voluntary licensing agreement for patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), to help enable access in 90 countries.

The 90 countries include least developed, low-income, lower middle-income and Sub-Saharan African countries.

As part of the agreement, selected generics manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in the 90 countries, subject to required regulatory approvals being obtained.

MPP, the United Nations-backed public health organisation, said that cabotegravir LA for PrEP is the first long-acting HIV prevention medicine.

‘Game-changing’ moment

Deborah Waterhouse, CEO at ViiV Healthcare, said: “Today’s announcement represents a potentially game-changing moment in HIV prevention. Enabling at-scale access to generic cabotegravir LA for PrEP could play a significant role in averting the transmission of HIV, particularly amongst women and adolescent girls, and help end the HIV epidemic.”

The announcement comes seven months after the US Food and Drug Administration gave the first regulatory approval of cabotegravir LA for PrEP in the world.

The drug is not currently approved for use in HIV prevention anywhere outside of the US, but 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.

Charles Gore, MPP executive director said: “This licence 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.”

Women and girls disproportionately affected

The Sustainable Development Goals are a collection of 17 interlinked global goals set up in 2015 by the United Nations General Assembly and are intended to be achieved by 2030.

Every year, there are  approximately 1.5 million new cases of HIV worldwide, most of which occur in resource-limited countries, with women and adolescent girls disproportionately impacted, said MPP.

It added that oral PrEP options are available in many countries, but challenges with adherence and stigma have limited their impact in some populations so access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.

The licence builds on ViiV's and MPP’s long-standing partnership, which has facilitated the manufacture and sale of generic versions of oral ViiV medicines in countries most affected by HIV and least able to pay for treatment and care.

As of December 2021, voluntary licensing has enabled access to generic products containing another of ViiV Healthcare’s innovative medicines, dolutegravir, for at least 20 million people living with HIV in low- and middle-income countries.


More on this story

Big Pharma
6 December 2022   Medicines Patent Pool deals have given 20 million people access to HIV treatment | Full list of sub-licensees.

More on this story

Big Pharma
6 December 2022   Medicines Patent Pool deals have given 20 million people access to HIV treatment | Full list of sub-licensees.