J&J, nonprofit in TB drug tie-up
Los Angeles, June 17, 2009
Healthcare company Johnson & Johnson said on Wednesday it has joined with the nonprofit Global Alliance for TB Drug Development to speed commercialisation of its experimental tuberculosis drug, known as TMC207.
The drug, designed to interfere with an enzyme needed by the bacteria responsible for tuberculosis to store energy, could become the first TB medicine with a new mechanism of action in 40 years.
Under the agreement, J&J will continue to develop TMC207 for the treatment of multiple-drug resistant TB, and on approval, will establish an access program to ensure the compound reaches people in developing countries.
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.
In addition, J&J will collaborate with the TB Alliance on a discovery research program to identify new compounds for the treatment of TB. The rights for any new compounds will belong to the TB Alliance under a royalty-free license.
Costs for the development of TMC207 will be shared.
A small trial showed that TMC207, when added to a standard cocktail of five other TB medicines, cleared traces of the tuberculosis bacteria in the sputum of 48 percent of the volunteers after eight weeks. Only 9 percent of patients given the five older drugs alone showed that type of improvement.
About 1.8 million people die worldwide each year from tuberculosis and a third of the world's population -- 2 billion people -- are infected, according to the World Health Organization. The WHO says that of 9 million new TB cases annually, about 490,000 are multiple-drug resistant TB, or MDR-TB, and about 40,000 are extensively drug resistant.
Fewer than 3 percent of MDR-TB cases worldwide are being treated according to WHO recommendations. The bacteria is extremely difficult to treat because it can remain dormant in the body, unresponsive to drugs. That means patients have to take medicine for a long time, and people often stop their therapy, allowing resistance to develop.
"To make a meaningful contribution to the global fight against TB, we knew we had to take a novel approach," Dr. Paul Stoffels, head of global pharmaceutical research and development at J&J said in a statement.
The TB Alliance is funded by the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs, the United Kingdom Department for International Development, and the United States Agency for International Development. - Reuters