Global Alliance for TB Drug Development (TB Alliance)

Partnership objectives

  1. Develop a novel treatment regimen for drug sensitive pulmonary TB to shorten the treatment duration from 6 to 4 months.
  2. Make Moxifloxacin available to patients in least developed countries at a reduced price.

At any given moment, more than 12 million people around the world are suffering from active TB infection. At any given moment, more than 12 million people around the world are suffering from active TB infection. Copyright TB Alliance

What are the health needs and challenges?

TB is second only to HIV as the leading infectious killer of adults worldwide. It is among the three greatest causes of death of women aged 15-44 and is the leading infectious cause of death among people with HIV/AIDS.

Active TB attacks the respiratory system and other organs, destroying body tissue. The disease is contagious, spreading through the air by coughing, sneezing, or even talking. An estimated nine million new active cases develop each year. At any given moment, more than 12 million people around the world are suffering from an active infection.

Description of partnership activities and how they address needs and challenges

The Global Alliance for TB Drug Development (TB Alliance), established in 2000, brings together industry, NGOs, governments, foundations and more than 30 partners around the world to accelerate the discovery and development of cost-effective new medicines. The TB Alliance draws on the best practices and resources of the public and private sectors to accelerate the discovery and development of cost-effective new anti-TB medicines, which should shorten or simplify treatment, provide a more effective treatment of multidrug-resistant TB and improve treatment of latent TB infection.

The founders of the TB Alliance are the Bill and Melinda Gates Foundation, the Rockefeller Foundation, the US Agency for International Development (USAID), Irish Aid, the Netherlands' Ministry of Foreign Affairs and the UK Department of International Development (DFID). Company partners include AstraZeneca, Bayer HealthCare, GlaxoSmithKline and Novartis.

The partnership functions as a virtual R&D organization. By outsourcing medicine research and development projects, medicine compounds are moved along the development line to achieve regulatory approval and bring them to market at affordable prices for those countries experiencing the highest burden from TB. TB Alliance activities in low and middle income countries include clinical trials in Kenya, South Africa and Zambia and non-clinical or preclinical work in China and India.

The current six-month standard treatment period for TB is based on four medicines that were discovered over 40 years ago. Medicines must be taken for 6 to 8 months, frequently under the direct supervision of healthcare professionals as Directly Observed Therapy– short course (DOTS). A reduced TB treatment regimen should help improve patient compliance, reduce treatment failure rates and decrease the TB-related health costs in endemic disease countries.

Pre-clinical studies have shown that moxifloxacin can reduce the treatment period by two months, if it is administered in place of Isoniazid – one of the pillars of current TB treatment. The results of clinical phase-II studies support the treatment reduction potential of moxifloxacin. Moxifloxacin is currently approved in 123 countries for the treatment of acute bacterial infections but is currently not approved for the treatment of TB, including multi-drug resistant TB (MDR-TB).

Moxifloxacin is currently being assessed in a large, phase-III study (REMoxTB) which may result in the registration of the first new drug approved for the treatment of drug-sensitive TB in nearly 50 years. In all studies, Bayer has made the antibiotic moxifloxacin available free of charge and in cases of positive results will also bear the costs for the approval procedures. To learn more about these trails, click here.

If the data from the clinical trial is positive, TB Alliance and Bayer Healthcare will seek registration of moxifloxacin as part of a multi-drug regimen for drug-sensitive TB and work to make it widely adopted into existing TB treatment programs, and available and affordable to patients who most need it.

Forging global partnerships, the TB Alliance has partnered with some of the world's leading drug developers to jointly manage TB drug discovery portfolios consisting of multiple TB drug discovery programs. This approach aligns target product profiles, makes efficient use of resources, and leverages the expertise and contributions of each partner to have a significant impact on the global discovery portfolio. The TB Alliance jointly manages TB drug discovery portfolios with AstraZeneca and GlaxoSmithKline.

In March 2005, GlaxoSmithKline and the Global Alliance for TB Drug Development (TB Alliance) announced a joint discovery partnership to improve the treatment of tuberculosis (TB).  The TB Alliance supports 15 full-time scientists working exclusively on the TB drug program at the GSK R&D facility in Tres Cantos, Spain. To learn more about this discovery partnership, click here.

In August 2014 Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).

Lessons learned             

The cooperation model of a multi-partnership consortium should be regarded as a new “blueprint” for developing novel treatments for patients in underdeveloped countries suffering from neglected diseases.

Summary of impact and forward looking information

Provided that results of the REMoxTB study will be positive, the new indication for a Moxifloxacin containing combination regimen for treatment of pulmonary TB with a shorter duration is planned to be submitted to regulatory authorities in 2014. As part of discovering new drugs,1.5 million compounds have been tested for anti-TB activity and any medicines discovered will be made as affordable and accessible as possible to those most in need.

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Partnership information

Company(ies) AstraZeneca , Bayer , Eli Lilly and Company , GlaxoSmithKline , Johnson & Johnson , Novartis , Sanofi

Partner(s) Beijing Institute of Materia Medica, Beijing Tuberculosis and Thoracic Tumor Research Institute, Bill and Melinda Gates Foundation, Cumbre, European Commission, European Union, Global Health Innovative Technology (GHIT) Fund, Irish Aid, KRICT, Netherlands Ministry of Foreign Affairs, Rockefeller Foundation, UK Department for International Development (DFID), UNITAID, University of Auckland, New Zealand, University of Illinois, US Agency for International Development (USAID), US Food and Drug Administration (US FDA), US National Institutes of Health (NIH), Yonsei University, Korea

Type of Partner(s) Academia / Hospitals, Government, Multilaterals, NGOs, Other Business

Therapeutic Focus Infectious Diseases

Disease(s) Tuberculosis

Program Type(s) Research & Development - Development of Treatments

Targeted Population(s) Elderly, Men, People with low income, Women

Region(s) East Asia & Pacific, South Asia, Sub-Saharan Africa

Number of Countries 4

Country(ies) China, India, South Africa, Zambia

Start Date 2005

More information TB Alliance

Anticipated completion date Ongoing

« Promising compounds such as this need to be nurtured. Drug resistance is emerging in every country against a disease that is killing someone every 15 seconds, and the new-drug pipeline is little more than a trickle. »

Peter Small, TB expert with the Bill and Melinda Gates Foundation