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Organization Contact Information

Name: GSK
Street 1: 980 Great West Road
Street 2:
City: Brentford
Province: Middlesex
Post Code: TW8 9GS
Country: United Kingdom of Great Britain and Northern Ireland
Phone: 07788351549
Organization Email: samantha.x.johnson@gsk.com
Web Site: http://www.gsk.com
Other Online Presence:

Focal Point Contact Information

Salutation: Ms
First Name: Samantha
Last Name: Johnson
Title: Senior Manager, Enterprise Issues - Global Corporate Government Affairs and Policy
Email: samantha.x.johnson@gsk.com
Phone:  

Alternate Focal Point Contact Information

Salutation: Ms
First Name: Corry
Last Name: Jacobs
Title: Head of Corporate Government Affairs, Global Health & Trade
Email: corry.x.jacobs@gsk.com
Phone:  

General Information

Board Constituency: None
Is your organization legally registered in your country: Yes
If yes, please enter your registration number: 3888792
Organization Type - Primary: Private Sector
Organization Type - Secondary: Company
Organization Description:
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceuticals, vaccines and consumer healthcare products.

Over the last 15 years, we have been working with Aeras, a not-for-profit biotech, to develop a TB candidate vaccine, with the support of the Bill & Melinda Gates Foundation, the UK’s Department for International Development and others. As Aeras’ TB vaccine clinical programme was recently acquired by IAVI, a longstanding GSK collaborator in HIV vaccine development, IAVI will now also be collaborating with us on our TB vaccine programme.

Our candidate vaccine is currently being tested in a phase II clinical trial in TB-endemic regions of Africa. Primary results after a two-year follow-up of the study’s participants, published in the New England Journal of Medicine, showed the candidate vaccine could help prevent adults with latent TB infection from becoming sick with pulmonary TB. The study is still ongoing and is expected to complete at the end of 2018; and the analysis of the final study results is planned for 2019.

Potential new medicines for TB are also being developed in our R&D unit in Tres Cantos, Spain – a site where GSK and visiting scientists collaborate on research dedicated to developing treatments for diseases that disproportionately affect developing countries.

GSK is an active member of several collaborations focused on developing new treatments for TB, including multi-drug resistant forms of the infection. In 2012, we joined the TB Drug Accelerator Program – a partnership with a number of other pharmaceutical and public sector research institutions and the Bill & Melinda Gates Foundation, aiming to speed up the discovery of new medicines by collaborating on early stage research. We are also part of Predict TB, one of the world’s only initiatives focused on tackling some of the very early-stage barriers to the discovery of ne
 
Do you know about the UNHLM declaration: Yes

Specializations / Areas of Work

Advocacy
Engaging political leaders and ensuring inclusive leadership
Funding, including innovative and optimized approach to funding TB Care
Provision of drugs, diagnostics and commodities
Research and Development

Other Organization Information

Total number of staff in your organization: 100 +
Number of full-time staff who are directly involved with TB: 26 - 50
Number of part-time staff who are directly involved with TB: 0
Number of volunteers who are directly involved with TB: 0
 
How did you hear about the Stop TB Partnership: Other partners
If you were informed or referred by another partner of the Stop TB Partnership please tell us who:
Why do you wish join the Stop TB Partnership: Involvement in Stop TB Working Groups
 
Are you a member of a Stop TB national partnership: No
Are you in contact with your national TB programme: No
Please tell us how your organization is contributing to your country's national TB control plan:
N/A GSK is a global organisation
 

Geographical Reach

Which country is your headquarters located in: United Kingdom of Great Britain and Northern Ireland
Which countries do you do operate in:
(This includes countries you are conducting activities in)
Afghanistan
Algeria
Andorra
Angola
Argentina
Armenia
Australia
Austria
Bangladesh
Belgium
Benin
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Central African Republic
Chad
Chile
China
Colombia
Congo
Costa Rica
Cote d'Ivoire
Croatia
Cyprus
Czech Republic
Democratic Republic of the Congo
Denmark
Djibouti
Dominican Republic
Ecuador
Egypt
El Salvador
Eritrea
Estonia
Ethiopia
Finland
France
Gabon
Gambia
Germany
Ghana
Greece
Guatemala
Guinea
Honduras
Hungary
Iceland
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kenya
Lao People's Democratic Republic
Latvia
Lebanon
Liberia
Lithuania
Madagascar
Malawi
Malaysia
Mali
Malta
Mauritania
Mauritius
Mexico
Morocco
Mozambique
Myanmar
Namibia
Netherlands
New Zealand
Niger
Nigeria
Norway
Pakistan
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Republic of Korea
Republic of Moldova
Republic of Serbia
Romania
Russian Federation
Rwanda
Saudi Arabia
Senegal
Sierra Leone
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Thailand
Togo
Tunisia
Turkey
Uganda
Ukraine
United Kingdom of Great Britain and Northern Ireland
United Republic of Tanzania
United States of America
Uruguay
Uzbekistan
Venezuela
Viet Nam
Yemen
Zambia
Zimbabwe

Contribution

Please tell us how your organization will contribute to the Global Plan to Stop TB by briefly describing its involvement in any of the areas of work listed below:

TB Care Delivery:
GSK participates in and inputs into the pharmaceutical industry delegations presence, communications and advocacy in international for a where TB is discussed, such as the World Health Organisation's Executive Board and World Health Assembly, and the UN General Assembly.
For example, Rogerio Ribeiro, GSK's Senior Vice President of Global Health attended the 2018 UN General Assembly and spoke at the Stop TB Partnership and partners TB Summit about our pipeline and what is needed to achieve impact. Pauline Williams, GSK's Head of Global Health R&D, shares her perspective on what it takes to research new treatments and deliver them to patients around the world in global fora. For example, Pauline was in New York for the United Nations General Assembly for two important meetings looking at how we make further progress against some of the biggest healthcare challenges we face. The first was the Goalkeeper 18 summit, hosted by Bill Gates. Here, world leaders in politics, business, policy and academia explored how we work together to meet the UN Sustainable Development Goals – an ambitious set of targets for achieving a better, and healthier, future for all. The second meeting drilled down into how funders, pharmaceutical companies, academics and regulators can collaborate on a transformative drug regime to combat TB.


Drug-Resistant TB:
GSK has its own TB R&D discovery performance unit and is an active member of several collaborations focused on developing new treatments for TB, including multi-drug resistant forms of the infection.

TB-HIV:
Our HIV business is managed through ViiV Healthcare, a global specialist HIV company established in 2009, that we majority own, with Pfizer and Shionogi as shareholders. A leading global company focused on advancing science into HIV treatment, prevention and care, ViiV Healthcare has had significant recent successes with regulatory approvals and industry leading launches of new antiretrovirals.
In March 2018, ViiV Healthcare announced interim (Week 24) study results from INSPIRING, a phase IIIb study evaluating the safety and efficacy of dolutegravir in antiretroviral treatment-naive (ART-naïve) adults with HIV, co-infected with tuberculosis (TB). Results presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, showed that dolutegravir when administered at 50mg twice-daily with dual nucleoside reverse transcriptase inhibitors (NRTI), was effective and well-tolerated in HIV/TB co-infected adults receiving rifampin-based TB therapy.

New TB Drugs:
As part of our response to the challenges faced in the developing world, in 2001 we established our research centre at Tres Cantos in Madrid to work exclusively on tackling diseases of the developing world. The unit focuses primarily on malaria and tuberculosis, along with certain neglected tropical diseases. Research decisions at Tres Cantos are prioritised on their socio-economic and public health benefits, rather than on commercial returns.
GSK has its own TB R&D discovery performance unit and is an active member of several collaborations focused on developing new treatments for TB, including multi-drug resistant forms of the infection. In 2012, we joined the TB Drug Accelerator Program – a partnership with a number of other pharmaceutical and public sector research institutions and the Bill & Melinda Gates Foundation, aiming to speed up the discovery of new medicines by collaborating on early stage research. We are also part of Predict TB, one of the world’s only initiatives focused on tackling some of the very early-stage barriers to the discovery of new TB treatments.
In 2012, our scientists screened our entire library of more than two million compounds – the building blocks of future medicines – for any showing signs of activity against TB. The 200 compounds subsequently identified were made freely available online, for external scientists to carry out their own research. To date, we have shared copies of these compounds with 30 research groups around the world, who are also working to tackle TB.

The Tres Cantos Open Lab Foundation is a charity established in 2010 with £5 million in seed funding from GSK to support suitable research. In October 2012, GSK announced a further £5 million of funding for the Foundation, followed by an additional £5m committed in September 2018.
To date, more than 250 research proposals have been evaluated, 65 projects have been approved and 80 Open Lab scientists have been trained in global health drug discovery in an industrial setting. A significant pipeline of candidate medicines has been delivered through this model – including a novel TB drug candidate with treatment shortening potential. Other projects underway include innovative research into malaria, Chagas disease, leishmaniasis and sleeping sickness.

New TB Vaccines:
Over the last 15 years, we have been working with Aeras, a not-for-profit biotech, to develop a TB candidate vaccine, with the support of the Bill & Melinda Gates Foundation, the UK’s Department for International Development and others. As Aeras’ TB vaccine clinical program was recently acquired by IAVI, a longstanding GSK collaborator in HIV vaccine development, IAVI will now also be collaborating with us on our TB vaccine program.
In September 2018 GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.
These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.
The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is conducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least 2 years to detect evidence of pulmonary tuberculosis disease. In the vaccine group, 10 participants developed active pulmonary tuberculosis compared to 22 participants in the placebo group. The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up. The study is sponsored by GSK and conducted in partnership with Aeras. Funders of Aeras for this study are the Bill & Melinda Gates Foundation, the United Kingdom’s Department for International Development, the Directorate General for International Cooperation in the Netherlands, and the Australian Agency for International Development.
The data published in the New England Journal of Medicine (DOI: NEJMdo005415) are initial findings, in which variable efficacy is observed in some sub-populations. However, these sub-group analyses include small numbers of people and therefore will need to be confirmed. Final analysis of these subgroups will be conducted after the study concludes in 2019, at which time there may be more data points to provide greater insight into the initially observed variability.
Nearly all participants (99%) in the study consented to enter into a biobanking study sponsored by Aeras. The samples collected during this study will allow researchers to further investigate the potential vaccine-induced mechanisms of protection against tuberculosis and attempt to identify markers that indicate those at high risk of developing tuberculosis disease. (www.clinicaltrials.gov NCT02097095).

Research:
As part of our response to the challenges faced in the developing world, in 2001 we established our research centre at Tres Cantos in Madrid to work exclusively on tackling diseases of the developing world. The unit focuses primarily on malaria and tuberculosis, along with certain neglected tropical diseases. Research decisions at Tres Cantos are prioritised on their socio-economic and public health benefits, rather than on commercial returns.
GSK has its own TB R&D discovery performance unit and is an active member of several collaborations focused on developing new treatments for TB, including multi-drug resistant forms of the infection. In 2012, we joined the TB Drug Accelerator Program – a partnership with a number of other pharmaceutical and public sector research institutions and the Bill & Melinda Gates Foundation, aiming to speed up the discovery of new medicines by collaborating on early stage research. We are also part of Predict TB, one of the world’s only initiatives focused on tackling some of the very early-stage barriers to the discovery of new TB treatments.
In 2012, our scientists screened our entire library of more than two million compounds – the building blocks of future medicines – for any showing signs of activity against TB. The 200 compounds subsequently identified were made freely available online, for external scientists to carry out their own research. To date, we have shared copies of these compounds with 30 research groups around the world, who are also working to tackle TB.

The Tres Cantos Open Lab Foundation is a charity established in 2010 with £5 million in seed funding from GSK to support suitable research. In October 2012, GSK announced a further £5 million of funding for the Foundation, followed by an additional £5m committed in September 2018.
To date, more than 250 research proposals have been evaluated, 65 projects have been approved and 80 Open Lab scientists have been trained in global health drug discovery in an industrial setting. A significant pipeline of candidate medicines has been delivered through this model – including a novel TB drug candidate with treatment shortening potential. Other projects underway include innovative research into malaria, Chagas disease, leishmaniasis and sleeping sickness.

Declaration

Declaration of interests:
GSK have candidate TB pharmaceutical products and a candidate TB vaccine in our pipeline, as disclosed elsewhere in this form.

Application date: December 13, 2018
Last updated: December 13, 2018