A landmark collaboration could see the development of the first new-action tuberculosis drug in 40 years.
Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership, and Tibotec, a Johnson & Johnson company, have joined forces to focus on the development of the new experimental drug TMC207.
The partnership will combine the expertise and resources of the two organisations, and should further studies build on the success of an ongoing Phase II study of TMC207, this could become the first TB drug with a new mechanism of action in 40 years.
The development would be a significant breakthrough in the treatment of the disease, which has seen a resurgence in recent times as well as the rise of multi-drug resistant strains.
“We see tremendous potential in this collaboration and in the future of TMC207 as part of a critically-needed new TB regimen,” said Dr Mel Spigelman, TB Alliance President and Chief Executive.
“To make a meaningful contribution to the global fight against TB, we knew we had to take a novel approach,” said Dr Paul Stoffels, Global Head of Pharmaceutical Research and Development at Johnson & Johnson. “With MDR-TB becoming a growing global health threat and hundreds of thousands of unnecessary deaths from drug-susceptible TB occurring, we are committed to accelerating the development of new drug regimens for tuberculosis.”
Under the terms of the agreement, Tibotec will continue to develop TMC207 for the treatment of multi-drug resistant TB, though development costs will be shared. On approval, Tibotec will establish an access programme to ensure the compound reaches those in developing countries.
The agreement also grants the TB alliance a royalty-free license for the worldwide development and access to TMC207 in the field of drug susceptible TB.
The two organisations will also collaborate on a discovery research programme to identify new compounds with the rights for any compounds belonging to the TB Alliance under a royalty free license.
In the ongoing Phase II study of TMC207, it was found that 48% of MDR-TB patients receiving TMC207 in combination with standard treatment converted to negative sputum culture after eight weeks compared with 9% of those who received placebo and standard treatment. The results have been published in the New England Journal of Medicine.
