Janssen R&D Collaboration with TB Alliance

Partnership objective

Development of TMC207 as part of a new regimen for Drug-Sensitive TB.

Janssen collaborates with the TB Alliance in a discovery research program to identify compounds for the treatment of TB. Janssen collaborates with the TB Alliance in a discovery research program to identify compounds for the treatment of TB. Copyright Janssen

What are the health needs and challenges?

Tuberculosis (TB), often thought of as a disease of the past, continues to plague the world’s most vulnerable populations. A curable disease, it claims the lives of 1.7 million people each year, according to the WHO. Ninety-eight percent of these deaths occur in the developing world, according to the U.S. Agency for International Development. More than 2 billion people, or roughly one-third of the world’s population, are infected with the microbes that cause TB. Of those infected, one in 10 will become sick with active TB.

The most popular vaccine used to treat TB was developed in the early 20th century using a bovine strain of the disease. Despite widespread use, the vaccine does not always work. It has been shown to protect against severe TB in children, but there is little evidence of effectiveness in adults. Furthermore, it can create a false-positive TB test in those who have been vaccinated.

To cure TB requires a regimen of several medicines that must be taken daily for six to nine months. But many patients fail to complete the treatment, or medication is incorrectly prescribed, which can lead to multidrug-resistant tuberculosis (MDR-TB).

Description of partnership activities and how they address needs and challenges:

Janssen Pharmaceutical Companies of Johnson & Johnson and the non-profit Global Alliance for TB Drug Development (TB Alliance) share their expertise and resources in the development of TMC207, which could become the first TB drug with a new mechanism of action in 40 years. Under the terms of the agreement, Janssen is developing TMC207 for the treatment of MDR-TB and, on approval, will work with global (Stop TB Partnership, WHO, etc.), regional and local stakeholders to ensure the product is appropriately used in accordance with international standards, affordable and available to patients in need. The agreement grants the TB Alliance a royalty-free license for the worldwide development and access to TMC207 in the field of drug-susceptible TB. Janssen and the TB Alliance will share expertise and resources in the development of TMC207. A number of Early Bactericidal Activity (EBA) studies have been conducted to establish dose finding and to facilitate new regimen selection. Drug-Drug Interaction (DDI) studies are also underway.

In addition, Janssen collaborates with the TB Alliance in a discovery research program to identify other new compounds for the treatment of TB. The rights for the newly discovered compounds for the treatment of tuberculosis will belong to the TB Alliance under a royalty-free license.

Summary of impact and forward looking information:

Dose finding results and results from early bactericidal activity trials, including bedaquiline combinations in patients, have been published and results from the second combination study with bedaquiline were presented at the 2013 stakeholders meeting.  Additional general updates were presented  at the 2013 CPTR meeting.

The discovery research program was extended from 3 to 4 years.

Partnership information

Company(ies) Johnson & Johnson

Partner(s) Global Alliance for TB Drug Development (TB Alliance), Stop TB Partnership, World Health Organization (WHO)

Type of Partner(s) IGOs, Multilaterals, PDPs

Therapeutic Focus Infectious Diseases

Disease(s) Tuberculosis

Program Type(s) Availability of Treatment - Technology Transfer - Scientific Collaboration and Knowledge Sharing, Research & Development - Development of Treatments

Targeted Population(s) Children, Marginalised / Indigenous People, Men, Patients in needs of treatment, People with low income, Women, Youth

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean, Middle East & North Africa, North America, South Asia, Sub-Saharan Africa

Number of Countries 143

Country(ies) Afghanistan, Albania, Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Azerbaijan, Bangladesh, Belarus, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Chile, China, Colombia, Comoros, Congo, Costa Rica, Côte d'Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Fiji, Gabon, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iran, Iraq, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kyrgyzstan, Lao PDR, Lebanon, Lesotho, Liberia, Libya, Lithuania, Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Mexico, Micronesia, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Romania, Russia, Rwanda, Samoa, Sao Tome and Principe, Senegal, Serbia, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Korea, Sri Lanka, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, Thailand, The Gambia, Timor-Leste, Togo, Tonga, Tunisia, Turkey, Turkmenistan, Tuvalu, Uganda, Ukraine, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Start Date 2003

More information J&J News

Anticipated completion date Ongoing

« The project is speeding the development of a potential new TB drug that could potentially save hundreds of thousands of lives. »

Myriam Haxaire-Theeuwes, Janssen Compound Development Team Leader