ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the Medicines Patent Pool, or MPP, 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.
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 Food and Drug Administration.
Each 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. 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 toward the goal of ending the epidemic, the company said.
The new voluntary license 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 million people living with HIV in low- and middle-income countries, as of December 2021.
“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, said Deborah Waterhouse, CEO at ViiV Healthcare.
“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,” she said.
“We are delighted to sign this voluntary license with ViiV for cabotegravir LA for PrEP. Long-acting technologies open up a whole new dimension that facilitates medicine uptake, and this product brings a much-needed option for those at risk,” said Charles Gore, MPP executive director.
“This license was negotiated in double-quick time and is another example of MPP’s continued commitment to making innovation available and affordable in low- and lower middle-income countries in the shortest possible time,” he said. “Rapid access to new technologies is our only hope of hitting the Sustainable Development Goal targets.”