ViiV Healthcare and the Medicines Patent Pool expand access to dolutegravir-based regimens for people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia with innovative new licensing agreement

London, 30 November 2020 - ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, and the Medicines Patent Pool (MPP) today announced the signing of a new voluntary licensing agreement to enable greater access in certain upper-middle-income countries (UMICs) to dolutegravir (DTG)-based regimens which have been recommended by the World Health Organization (WHO)1 or the US Department of Health and Human Services2 (DHHS). These countries are Azerbaijan, Belarus, Kazakhstan and Malaysia.

Recognising the specific challenges faced by these countries and in response to feedback from the HIV community and the governments, ViiV Healthcare and MPP have created this first-of-its-kind agreement to enable increased access and affordability to generic DTG-based HIV treatment regimens, while also supporting continued investment in much needed innovation. Through this novel agreement, selected generic manufacturers will have the opportunity to supply DTG-based medicines at a significantly reduced price compared to local prices at the time of this agreement, in turn enabling greater access to these medicines for people living with HIV in each country.

Charles Gore, MPP Executive Director said, “Increasing access to life-saving medicines for low- and middle-income countries is at the core of our mission and we have been able to achieve that over the last 10 years through strong partnerships that span industry, generics manufacturers, governments and civil society. This new and first-of-its-kind agreement with ViiV Healthcare, that is specifically aimed at increasing access in these upper middle-income countries, will mean that people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia will have greater access to affordable WHO-recommended DTG-based treatment regimens.”

Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at WHO said: “WHO recommends the use of DTG as part of the preferred first-line and second-line regimen for people living with HIV, including pregnant women and those of childbearing potential. WHO welcomes this licence and through our regional and country offices have worked alongside governments and MPP to ensure that this agreement responds to people’s HIV treatment needs in these countries.”

ViiV Healthcare and MPP will now work closely with governments and selected generic manufacturers to make generic DTG-based regimens available as soon as possible in the four countries.

Deborah Waterhouse, CEO at ViiV Healthcare said, “We are 100% committed to our mission of leaving no person living with HIV behind and are proud to have built upon our existing partnership with MPP to enable improved access to DTG in these upper-middle-income countries, in line with WHO HIV treatment guidelines. Through this agreement, we have created a new model that enables improved access to treatment and increased affordability while supporting continued investment in research and development of much needed innovative medicines to help ensure better long-term outcomes for people living with HIV.”


Notes to Editors

Evolving our approach to access in UMICs
The new voluntary licence agreement will enable the supply of generic DTG-based regimens that are recommended by WHO or the US DHHS. The four countries that will benefit from this agreement are not covered by ViiV Healthcare’s existing licences for DTG-based medicines and are all upper-middle-income countries which are eligible for Overseas Development Assistance as defined by the Organisation for Economic Cooperation and Development (OECD) Development Assistance Committee (DAC) list, are not members of the G20 or OECD3, and where ViiV Healthcare holds a patent for DTG. These four countries will also have access to ViiV Healthcare’s existing paediatric DTG voluntary licences.

About the Medicines Patent Pool
MPP 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, 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, MPP has signed agreements with ten patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC).

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’s aims are 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.


About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.


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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q3 Results and any impacts of the COVID-19 pandemic.

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References:

1. World Health Organization. WHO recommends dolutegravir as preferred HIV treatment option in all populations. Available at: https://www.who.int/news/item/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations Last accessed: November 2020
2. Department of Health and Human Services. Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf Last accessed: November 2020
3. Organisation for Economic Cooperation and Development (OECD). Develop Assistance Committee (DAC) list of Overseas Development Assistance (ODA) recipients. Effective for reporting on 2020 flows. Available at: https://www.oecd.org/dac/financing-sustainable-development/development-finance-standards/DAC-List-of-ODA-Recipients-for-reporting-2020-flows.pdf Last accessed: November 2020