The Medicines Patent Pool partners with two generic manufacturers to scale up access to generic dolutegravir in selected upper-middle-income countries
22 April 2021
Geneva – The Medicines Patent Pool (MPP) today announced that it signed sublicence agreements with pharmaceutical companies Hetero and Viatris (through its subsidiary Mylan), to manufacture and supply dolutegravir (DTG) and DTG-based regimen to Azerbaijan, Belarus, Kazakhstan and Malaysia.
“We are delighted that more people living with HIV in the four countries will soon be able to access DTG-based regimens, especially TLD (tenofovir disoproxil fumarate/lamivudine/dolutegravir), the first-line regimen recommended by the World Health Organization (WHO), which will now be available in these countries in a single pill,” says Charles Gore, Executive Director of MPP.
Recognising the specific challenges faced by these four upper-middle-income countries (UMICs) and in response to feedback from the HIV community and the governments, ViiV Healthcare and MPP signed a first-of-its-kind licence agreement to enable increased access and affordability to generic DTG-based treatment regimens, while also supporting continued investment in much needed innovation. The licence agreement permits selected generic manufacturers to produce and supply high-quality versions of DTG and TLD in the four countries.
“At Hetero we are thrilled to have signed this sublicence with MPP that will benefit so many people living with HIV in these countries,” said Bhavesh Shah, Director-International Marketing, Hetero. “In the fight against HIV/AIDS it is vital that no one is left behind just because of where they live.”
“We are proud to have been selected as a partner to provide dolutegravir to these countries which are in need of new treatment formulations. This milestone reflects our mission to empower people worldwide to live healthier at every stage of life through partnerships that leverage our collective expertise to connect people to products and services they need,” said Arvind Kanda, Head of ARV, API, Sub-Saharan Africa and South Africa, Viatris. “In demonstration of our commitment to expand access to critical HIV treatments around the world, we have been on the forefront in the global fight against HIV/AIDS for more than a decade with the goal of building healthier, more sustainable communities.”
Hetero and Viatris (through its subsidiary Mylan) were selected after a rigorous, thorough and impartial process, are long-standing partners of MPP and have a proven track record of developing, manufacturing and supplying essential medicines to countries from all around the world, including low- and middle-income countries. As Hetero and Mylan have already received approvals for DTG and TLD from the U.S. Food and Drug Administration and WHO prequalification, they will be able to supply these much-needed products rapidly to the four countries. A third generic manufacturer is in the process of being selected.