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ViiV Healthcare: Antiretroviral (ARV) licensing

Active Since: 2014

Contributing to SDGs…

Expanding and accelerating access to HIV treatment for people living with HIV across least-developed countries, low-income countries, lower-middle-income countries, Sub-Saharan Africa, and some upper middle-income countries.

MEMBER COMPANIES

PARTNER ORGANISATIONS

  • Global NGOs

    Medicines Patent Pool

    Contribution

    The Medicines Patent Pool (MPP) work to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.

    Clinton Health Access Initiative

  • Intergovernmental Organizations and Multilaterals

    UNITAID

  • Pharma (Non-IPFMA Member)

    ViiV Healthcare

    Contribution

    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’s aim is 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.

    Aurobindo Pharma

  • Generic manufacturers

    ViiV Healthcare

    Contribution

    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’s aim is 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.

    Adcock Ingram Limited and Adcock Ingram Healthcare (PTY) Limited

    Arene Life Sciences Limited

    Auhui Biochem United Pharmaceutical Co. Ltd

    Celltrion Inc

    Cipla Limited

    Emcure Pharmaceuticals Limited

    Hetero Labs Limited

    Laurus Labs Private Limited

    Lupin Pharmaceuticals Inc

    Mangalam Drugs & Organics Ltd

    MacLeods Pharmaceuticals Ltd

    Micro Labs Limited

    Mylan

    Sohanghai Desano Pharmaceuticals Company

    Strides Pharma Science Limited

    Zhejiang Langhua Pharmaceutical Co

    Sun Pharmaceutical Industries Limited

  • Logistics and supply chain

    Medicines Patent Pool

    Contribution

    The Medicines Patent Pool (MPP) work to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.

Objectives

Scaling up access to treatment for people living with HIV to enable the rapid and broad global introduction of dolutegravir (DTG). This HIV medicine is currently recognised as a global health priority product, recommended by the World Health Organization (WHO) as a preferred antiretroviral (ARV) option for an initial combination regimen for treatment-naïve adults living with HIV as well as in later lines of therapy.

At ViiV Healthcare we are committed to playing our part in addressing access to medicines challenges by taking an innovative, responsible, and sustainable approach.

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 (PLHIV) and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is 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.

37.9 million people are eligible for antiretroviral therapy (ART) under the ‘Treat All’ approach advocated by the World Health Organization 2016 guidelines. As of 2018 however, only around 62% of all PLHIV are accessing treatment. Scaling up access to treatment and ensuring that all PLHIV have access to HIV medicines is a crucial part of the global response to the epidemic. Not only does sustained access to ART lead to better medical and psycho-social outcomes for PLHIV, there is now a growing body of evidence that shows that effective ART can act as a robust prevention (Treatment as Prevention [TasP]) method and may help halt the progression of the HIV epidemic.

Improving treatment and care for PLHIV presents a complex challenge to the global HIV community. It can only be addressed if the significant barriers are tackled as a shared responsibility by all sectors of global society – governments, international agencies, civil society, academic institutions, the pharmaceutical industry and others.

Voluntary Licensing

Voluntary licences are granted by patent holders to allow a generic company to manufacture and sell versions of their products. GSK began offering voluntary licences for our antiretorvirals (ARVs) in 2001. GSK’s HIV portfolio transitioned to ViiV Healthcare in 2009. Since then ViiV Healthcare has expanded its approach to licensing both directly with generic manufacturers as well as indirectly via the UN-backed Medicines Patent Pool (MPP).

In 2013, ViiV Healthcare granted the MPP a voluntary licence for paediatric formulations of the ARV abacavir in the 118 countries home to most (98.7%) children living with HIV. In 2014 this agreement was extended to cover 121 countries in total. This is sublicensed to a single generic company (Aurobindo Pharma). ViiV Healthcare also has a direct licence for paediatric abacavir with Mylan Laboratories Ltd, initiated in June 2012 and later extended in 2015.

ViiV Healthcare has additional agreements with two generic manufacturers who hold paediatric dolutegravir sub-licences from the MPP — Mylan Laboratories Limited and Macleods Pharmaceuticals Limited — regarding the transfer of know-how and technical support to catalyse the development, registration, manufacture and supply of generic formulations of paediatric dolutegravir. These agreements are part of an innovative public-private partnership initiative between the Clinton Health Access Initiative (CHAI) and ViiV Healthcare, with financial support from Unitaid, to accelerate the development of optimal paediatric formulations of dolutegravir that was launched in July 2018.

In 2014, ViiV Healthcare granted four voluntary licences, two with the MPP and two directly with Aurobindo Pharma to rapidly expand access to dolutegravir, just three months after its approval by the European Medicines Agency (EMA). This agreement enabled generic manufacturers to produce and sell low-cost single or combination versions of DTG in all least developed, low-income, and sub-Saharan Africa (SSA) countries as well as some other upper middle-income countries (paediatric licence only).

In 2016, ViiV Healthcare announced an extension of overall country coverage of its existing licence agreement for adult formulation of dolutegravir to the MPP covering all lower middle- income countries, and in 2018 extended further to include Mongolia and Tunisia – following their reclassification as lower middle-income countries. This brought the total country coverage to 94 and 121 countries for the adult and paediatric agreements respectively. At the time of the extension to include lower middle-income countries, the agreements enabled 94% of adults and 99% of children living with HIV in the developing world to access generic versions of DTG in an accelerated timeframe. The licences are principally royalty free, with tiered royalties under the adult licence – in 12 lower middle-income countries. The licensing agreements have also enabled the production of a new fixed dose combination, tenofovir disoproxil fumarate/ lamivudine/dolutegravir (TLD), which combines the WHO-preferred treatment allowed generic manufacturers to include dolutegravir in regimen into a single pill. This is now the WHO’s preferred first line regimen.

SDGs THE PARTNERSHIP CONTRIBUTES TO

SDG 3: Good Health and Wellbeing

  1. 3.2: Reduce Under-5 Mortality 
  2. 3.3: Communicable Diseases & NTDs

SDG 5: Gender Equality

SDG 9: Industry Innovation and Infrastructure

SDG 10: Reduced Inequalities

SDG 17: Partnerships for the Goals 

RESULTS & MILESTONES

ViiV Healthcare has four licences for dolutegravir with the MPP and Aurobindo Pharma respectively – one for adults and one for paediatrics. As of July 2019, there are 18 licencees/sub-licencees for ViiV Healthcare’s dolutegravir adult formulation and 15 for the paedatric formulation.

The voluntary licence for manufacture and supply of dolutegravir now covers all lower middle-income countries, all low income, least developed, all sub-Saharan African countries and some upper middle-income countries (peadiatric licence only). At the time of its extension to cover all lower middle-income countries in 2016, this meant that more than 94% of adults and 99% of children living with HIV in the developing world were covered by the licence agreement.

By the end of 2018; at least 3.9 million people living with HIV were accessing generic DTG-based treatments across 61 developing countries, with over 36.9 million packs of dolutegravir and dolutegravir-based formulations of generic ARVs delivered between 2017 and 2018. As of July 2019, there are now 12 generic formulations containing dolutegravir with stringent regulatory approval to supply DTG-containing regimens: 5 for supply of DTG 50mg; 6 for supply of a new fixed dose combination, tenofovir disoproxil fumarate/ lamivudine/dolutegravir (TLD); and 1 for supply of fixed dose combination dolutegravir, emtricitabine, and tenofovir disoproxil fumarate (TAF-ED). 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.