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6 December 2022Big PharmaStaff Writer

Voluntary licensing opens up HIV treatment to 100 countries

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

Voluntary licensing agreements have opened up access to HIV treatment recommended by the World Health Organization (WHO) to more than 100 low- and middle-income countries (LMICs).

Most recently, Barbados, Belarus, Micronesia, and Tunisia have received tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD), the WHO-recommended first-line regimen for people living with HIV.

The voluntary licensing agreements signed between the Medicines Patent Pool (MPP) and ViiV Healthcare—a specialist in HIV care that is majority-owned by GSK, with Pfizer and Shionogi as shareholders—in 2014 and 2020 have allowed generic makers to produce and sell affordable single and combination versions of dolutegravir for adults and children in LMICs.

Charles Gore, executive director of MPP—which is a United Nations-backed public health organisation—said: “Today almost 20 million people take TLD daily. This treatment has been a gamechanger for those living with HIV as it’s a very potent and well-tolerated combination that contributes to suppressing the virus and reducing transmission.

“Our partnership with ViiV Healthcare shows that our public health-oriented licensing mechanism works, [and] that affordable access to the best new treatments is possible for people across LMICs.”

As of September, 2022, 11 sub-licensees of MPP have supplied more than 726 million packs of TLD in 103 countries. The Global Fund price for TLD ranges from $47 to $54 per patient per year depending on pack size.

The licensees are: Aurobindo, Celltrion, Cipla, Emcure, Hetero, Laurus, Lupin, Macleods, Viatris, Sun Pharma, and Strides.

Deborah Waterhouse, CEO of ViiV Healthcare, added: “Achieving this significant milestone reinforces how partnerships must play a powerful role in ending the HIV epidemic. We are very proud of our long-standing collaboration with MPP and how our work together is enabling access to our medicines for people living with HIV, regardless of their income, location, status, age, or gender.”

Earlier this year, MPP and Viiv Healthcare signed another voluntary licensing agreement.

This time, the agreement covers patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), to help enable access in 90 countries including 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.

Also, in September, MPP and French pharmaceutical company MedinCell signed a licence agreement for a long-acting drug formulation to fight malaria in low- and middle-income countries.

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29 July 2022   Pharma firm joins with patent pool to expand access to HIV treatment | 90 countries set to benefit from preventative medicine
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15 September 2022   Malaria remains endemic in 91 countries representing half of the world’s population | Licence is key to allow rapid access to innovation for those who need it most.

More on this story

Big Pharma
29 July 2022   Pharma firm joins with patent pool to expand access to HIV treatment | 90 countries set to benefit from preventative medicine
Big Pharma
15 September 2022   Malaria remains endemic in 91 countries representing half of the world’s population | Licence is key to allow rapid access to innovation for those who need it most.