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[1]) 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 African 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]

• Generic manufacturers have focused their supply of DTG-based regimens in countries with the most devastating levels of HIV, including Kenya, Malawi, South Africa and Tanzania. In South Africa alone – where there are 7.1 million people living with HIV  – nearly 6 million packs of treatment had been supplied by 2018.
• Over 36.9 million packs of dolutegravir and dolutegravir-based formulations of generic ARVs were delivered between 2017 and 2018 alone for the treatment of people living with HIV.
• In the developing world, more than one billion doses of DTG and DTG-based medicines had been delivered across 61 countries by the end of 2018.
• 13 companies are developing generic versions of dolutegravir and dolutegravir-based ARVs, of which five MPP generic manufacturing partners are have received approval from regulatory authorities to supply DTG 50mg and six are ready to supply TLD.
• Access to generic DTG and TLD has also been scaled up in many other developing countries outside of sub-Saharan Africa, such as Bolivia, Haiti, Myanmar and Ukraine, where unmet needs persist.

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.[2]

To find out more about the real-world impact of this partnership, click here.

Read the press release in French and Spanish

Notes to editors:

Patient groups and partners talk to DTG’s impact:

Violeta Ross, President of the Bolivian Network of People Living with HIV

“We, as people living with HIV, have the right to the best treatments available. […] For many people, the huge impact is not just the HIV positive test, but also the many changes they have to incorporate in their daily life because of the medication.”

Tapiwa Kujinga, Director of the Pan-African Treatment Access Movement (PATAM)

“When we compare to evidence coming from countries where dolutegravir has been rolled out, we realise that this is the drug that would make a big difference to our people.”

Sergey Dmitriyev, Policy and Advocacy Director, 100% Life.

“It was crucially important for Ukrainian patients to get access to generic DTG through the MPP- ViiV licence. 100% Life (former All-Ukrainian Network PLHIV) has proactively advocated for DTG expansion in Ukraine, which led to the first procurement of generic DTG in Ukraine ever and the government plans to cover 60% of patients with DTG-based regimens by 2020.”

Governments and other stakeholders talk to DTG’s impact:

Yogan Pillay, Deputy Director-General, National Department of Health, South Africa.

“New guidance by the World Health Organization that confirms the role of DTG-based regimens for first- and second-line HIV treatment for adults and children aligns with South Africa’s HIV treatment guidance released earlier this year. The availability of multiple quality-assured sources of affordable generic versions of DTG and TLD enables countries with large HIV programmes like South Africa to safely transition towards these new treatment options, with clear anticipated positive impacts for our community of people living with and affected by HIV.”

Dr. Htun Nyunt Oo, Program Manager, National AIDS Program, Myanmar.

“The MPP licence agreement with ViiV Healthcare is contributing to the rollout of key antiretroviral DTG in low- and lower middle-income countries including Myanmar. Indeed, DTG is already recommended as first line ART for adults and adolescents in the most recent National HIV clinical management guidelines. It has been very important for our program to have access to the HIV treatment dolutegravir at affordable prices. This would be enabling us to transition to a treatment regimen that is very effective with a high genetic barrier to resistance, in line with WHO recommendations. We look forward to continue the transition of the TLD combination in Myanmar.”

Andriy Klepikov, Executive Director of Alliance for Public Health and member of the Developing Country NGO Delegation to the Global Fund Board, member of IAS Governing Council.

“Universal Health Coverage requires improving access to essential medicines. Collaboration with the MPP is of strategic importance for the Alliance for Public Health and other stakeholders in Eastern Europe and Central Asia to expand access to the WHO-recommended medicines. The MPP-ViiV licence for DTG resulted in improved access to generic quality-assured DTG and the TLD combination at affordable prices in the region where the HIV prevalence is still high.”

About the licence agreement

The patient and country-specific data used for the basis of statistics quoted in this document can be accessed in full here: https://medicinespatentpool.org/progress-achievements/impact/stories-from-the-field/

The MPP and ViiV Healthcare signed their first HIV-licensing agreements for dolutegravir  in 2014.[xi] In 2016, this agreement was extended to include all lower middle-income countries as defined by the World Bank.[xii] In 2018, the partners signed an extension to the agreement that further expanded the territories to include Mongolia and Tunisia, which had been re-classified by the World Bank as lower-middle income countries since July 2017.[xiii]

ViiV Healthcare’s direct voluntary licences for dolutegravir for adults and children were first signed in 2014 with Aurobindo Pharma. This enabled Aurobindo to file for tentative approval with the U.S. Food and Drug Administration (USFDA) for the single formulation in May 2015,[xiv] making this the fastest filing for a generic antiretroviral following approval for the originator, which occurred in September 2016.[viii]

Globally, 36.9 million people are living with HIV.[xv] Dolutegravir (DTG) in combination with a NRTI backbone is now recommended by the World Health Organization as the preferred first-line regimen for people living with HIV.[i]

About dolutegravir

Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Tivicay is a registered trademark of the ViiV Healthcare group of companies. Click here for the latest registration status of Tivicay worldwide.

About the MPP

The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, the MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded by Unitaid, which serves as sole funder for the MPP’s activities in HIV, hepatitis C and tuberculosis. The MPP works with Aurobindo on HIV treatments abacavir paediatric, atazanavir, bictegravir, cobicistat, elvitegravir, emtricitabine, lopinavir, ritonavir, tenofovir alafenamide, and hepatitis C treatment daclatasvir. Aurobindo holds a direct licence with ViiV Healthcare for dolutegravir, a bi-lateral agreement that mirrors MPP’s approach to access-orientated licensing agreements.

More information about the Medicines Patent Pool, its public health mission and impact: https://medicinespatentpool.org/

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company aims to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com

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References

[1] Aurobindo Pharma holds a direct licence with ViiV Healthcare for DTG, a bi-lateral agreement that mirrors MPP’s approach to access-oriented licensing agreements. More information available here: DTG adult licence // DTG paediatric licence

[2] Who we work with – access full list of MPP partners here

[i] World Health Organization. Update of recommendations on first- and second-line antiretroviral regimens. July 2019. Policy Brief. Available at: https://apps.who.int/iris/bitstream/handle/10665/325892/WHO-CDS-HIV-19.15-eng.pdf?ua=1 Last accessed: July 2019.

[ii] World Health Organization. WHO recommends dolutegravir as preferred HIV treatment option in all populations. Available at: https://www.who.int/news-room/detail/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations Last accessed: July 2019.

[iii] Medicines Patent Pool. Dolutegravir – Paediatrics (DTG). Available at:  https://medicinespatentpool.org/licence-post/dolutegravir-paediatrics-dtg/ Last accessed: July 2019.

[iv] Medicines Patent Pool. Dolutegravir – Adult (DTG). Available at: https://medicinespatentpool.org/https://medicinespatentpool.org/licence-post/dolutegravir-adult-dtg/ Last accessed: July 2019.

[v] Medicines Patent Pool. Update on progress of sublicencees. Available at: https://medicinespatentpool.org/progress-achievements/access-to-medicines-tracker/?lang=fr#Online-Table-on-Progress-of-Sublicensees/ Last accessed: July 2019.

[vi] Medicines Patent Pool. Impact Analysis. Available at: https://medicinespatentpool.org/uploads/2020/05/DTG-Impact-Analysis_June19.pdf

[vii] ViiV Healthcare. ViiV Healthcare Announces Us Approval of Tivicay® (Dolutegravir) For the Treatment of HIV-1. Available at: https://www.viivhealthcare.com/en-gb/media/press-releases/2013/august/viiv-healthcare-announces-us-approval-of-tivicay-dolutegravir-for-the-treatment-of-hiv-1/ Last accessed: July 2019.

[viii] ViiV Healthcare. ViiV Healthcare Welcomes the FDA’s Tentative Approval Of The First Generic Dolutegravir From Aurobindo Pharma. Available at: https://www.viivhealthcare.com/en-gb/media/press-releases/2016/september/viiv-healthcare-welcomes-the-fda-s-tentative-approval-of-the-first-generic-dolutegravir-from-aurobindo-pharma/ Last accessed: July 2019.

[ix] Medicines Patent Pool. Access to Medicine Index hails the Medicines Patent Pool as key driver of access oriented licensing of pharmaceuticals. Available at: https://medicinespatentpool.org/news-publications-post/access-to-medicine-index-hails-the-medicines-patent-pool-as-key-driver-of-access-oriented-licensing-of-pharmaceuticals/ Last accessed: July 2019.

[x] UNAIDS. Country: South Africa. Available at: https://www.unaids.org/en/regionscountries/countries/southafrica Last accessed: July 2019.

[xi] Medicines Patent Pool. Medicines Patent Pool, ViiV Healthcare Sign Licence for The Most Recent HIV Medicine to Have Received Regulatory Approval. Available at: https://medicinespatentpool.org/news-publications-post/medicines-patent-pool-viiv-healthcare-sign-licence-for-the-most-recent-hiv-medicine-to-have-received-regulatory-approval/ Last accessed: July 2019.

[xii] Medicines Patent Pool. ViiV Healthcare, Medicines Patent Pool Extend Licence for Dolutegravir to all Lower Middle-Income Countries. Available at: https://medicinespatentpool.org/news-publications-post/viiv-healthcare-medicines-patent-pool-extend-licence-for-dolutegravir-to-all-lower-middle-income-countries/ Last accessed: July 2019.

[xiii] Medicines Patent Pool. The Medicines Patent Pool and ViiV Healthcare sign extension of HIV licence agreement for dolutegravir to include Mongolia and Tunisia. Available at: https://medicinespatentpool.org/news-publications-post/viiv-healthcare-medicines-patent-pool-extend-licence-for-dolutegravir-to-all-lower-middle-income-countries/ Last accessed: July 2019.

[xiv] ViiV Healthcare. ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV. Available at: https://www.viivhealthcare.com/en-gb/media/press-releases/2015/may/press-release/ Last accessed: July 2019.

[xv] World Health Organization. Global Observatory (GHO) data. Available at: https://www.who.int/gho/hiv/en/ Last accessed: July 2019.