Five years on, 3.9 million people in the developing world have access to HIV treatment dolutegravir, thanks to access-oriented voluntary licensing agreements
Innovative licensing agreements continue to provide access to dolutegravir in an unprecedented timeframe
Geneva & London, 30 July 2019. This year marks the fifth anniversary of the signing of two licensing agreements between ViiV Healthcare and the Medicines Patent Pool (MPP) that have allowed generic manufacturers to produce and sell single and combination versions of dolutegravir (DTG) for adults and children in countries with the highest burden of HIV.[i],[ii]
Currently, 18 generic manufacturers (17 sublicensees under the MPP and Aurobindo Pharma via a separate direct voluntary licence agreement with ViiV Healthcare) are authorised to produce and sell low-cost single or fixed-dose combination versions of DTG in all least developed, low-income, lower-middle income, and sub-Saharan Africa countries as well as some other upper middle-income countries (paediatric licence only), totalling 94 and 121 countries for the adult and paediatric agreements respectively.[iii],[iv] These licensing agreements have also allowed generic manufacturers to include dolutegravir in a newly developed fixed-dose combination, tenofovir disoproxil fumarate/ lamivudine/dolutegravir (TLD), which combines the WHO-preferred treatment regimen into a single pill.[v]
The agreements between the MPP and ViiV Healthcare were originally negotiated in 2014 to enable 94% of adults and 99% of children living with HIV in the developing world to access generic versions of DTG in an accelerated timeframe.[iii],[iv] By the end of 2018, nearly 3.9 million people living with HIV, across 61 countries in the developing world, had access to generic dolutegravir and TLD because of these innovative licensing arrangements.[vi] These initial figures are set to increase as countries adopt the updated WHO HIV treatment guidelines and generic manufacturers obtain further country registrations, enabling supply to additional countries within the voluntary licence territories.
Charles Gore, Executive Director at the MPP, said: “The five-year milestone provides us with a brilliant opportunity to talk about the impact public health-oriented licences can have in accelerating access to new treatments. The key achievement of our agreement with ViiV Healthcare is allowing millions of people in the countries hardest hit by the HIV epidemic to have access to dolutegravir at the same time as patients in high-income countries. Access to medicines is critical as it is unacceptable that people cannot afford the treatment they need.”
Deborah Waterhouse, CEO, ViiV Healthcare, said: “Enabling access to dolutegravir is an integral part of ViiV Healthcare’s commitment to ensuring no person living with HIV is left behind. To help us bring our medicines to people living with HIV across the developing world, our comprehensive access strategy is built upon having meaningful partnerships with public health organisations and generic companies alike. We are committed to continuing these partnerships to allow those most in need to have access to our medicines today and in the future.”
Following its approval by the U.S. Food & Drug Administration (USFDA) in August 2013,[vii] it took less than four years to bring generic DTG to people living with HIV across the developing world (adults and adolescents), with Aurobindo Pharma obtaining tentative FDA approval in September 2016[viii] and making its first shipment of the medicine in the spring of 2017.
Umesh Krishnamoorthy, Vice President and Business Unit Head, Global Anti-Virals, at Aurobindo Pharma, which holds a direct voluntary licensing agreement for DTG with ViiV Healthcare, said, “What we have achieved in the last five years is phenomenal and we are extremely proud to be part of this step-change in allowing dolutegravir to be made available to people living with HIV (PLHIV). Not only is it the speed in which Dolutegravir & its combinations is being delivered, but also the reach of our access approach. Aurobindo has applied for approval in 30 countries and 14 have already been approved. In the next year Aurobindo alone hopes to be reaching over 4 million people living with HIV with DTG-based regimens.”
The partnership model fosters close relationships with people living with HIV and their communities, industry and governments to prioritise access to affordable, quality medicines and has also enabled the MPP to become what the Access to Medicine Index has called “the central independent driver of access-orientated licensing in the pharmaceutical industry.” In its latest report[ix], the Access to Medicine Index cites ViiV Healthcare’s licences for dolutegravir (via the MPP and Aurobindo) as having “the widest reach of any non-exclusive voluntary licence agreed by any company in scope of the Index."[ix]
Unitaid Executive Director Lelio Marmora said: “This significant partnership between the MPP and ViiV Healthcare highlights the efficacy of the MPP’s model in speeding up access to innovative, quality-assured medicines. There is no doubt that affordability of generic dolutegravir has already been a game changer in the HIV space, with the scale-up of HIV treatments in low and lower-middle income countries being a major public health success. Unitaid remains committed to working to increase access to affordable antiretroviral treatments globally – including the development of paediatric formulations – to further accelerate the elimination of the AIDS epidemic.”
A sublicensee of the MPP, with WHO Prequalification and tentative USFDA approval for DTG and associated products including TLD, is Mylan Laboratories Limited. Arvind Kanda, Head Commercial – ARV, South Africa, sub-Saharan Africa and API at Mylan said, “We are pleased to have the opportunity through the MPP to deliver this critical treatment to the patients who need it, and as the world’s leading supplier of generic ARVs, we are committed to continuing the fight against HIV.”
Other generic manufacturers who have obtained quality assurance from the relevant regulatory authorities, required by the MPP licence agreement, and who are already supplying countries with DTG and/or recommended DTG-containing products are: Cipla, Emcure, Laurus, Hetero, Macleods, and Sun Pharma. All these organisations are key partners of the MPP.
To find out more about the real-world impact of this partnership, click here.