TB Alliance, Tibotec, form partnership to take forward new drug
Keith Alcorn
Wednesday, June 17, 2009
Aidsmap.com
Tibotec announced today that it has reached agreement with the Global Alliance for TB Drug Development that will give the alliance a global royalty-free license to develop Tibotec's new TB drug TMC-207 for first-line treatment in people with drug-susceptible TB. Tibotec and the TB Alliance will share future development costs.
TMC-207 is the first TB drug with a new mode of action to be developed in over 40 years, and scientists are hopeful that results of studies in drug-resistant patients indicate potential to dramatically shorten the current six to eight-month course of TB treatment needed in people with drug-susceptible TB.
Tibotec will continue to develop and retain the marketing rights for TMC-207 in drug-resistant TB. The company is currently conducting a phase II study of the drug; an 8-week interim analysis published earlier this month showed that patients who received TMC-207 in addition to standard treatment for multi-drug resistant TB were significantly more likely to be sputum smear-negative at week 8.
Tibotec says that when the drug is licensed for use in MDR-TB it will establish an access programme to ensure that the drug is available and affordable in developing countries.
Tibotec will also continue to look for new compounds to treat TB, and under the terms of the agreement will provide them on a royalty-free basis to the TB Alliance for future development.
The TB Alliance is a not-for-profit, product development partnership accelerating the discovery and development of new TB drugs that will shorten treatment, be effective against susceptible and resistant strains, be compatible with antiretroviral therapies for those HIV-TB patients currently on such therapies, and improve treatment of latent infection.
The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs (DGIS), the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID).
Tibotec's partnership with the TB Alliance indicates the future course the company will take in developing drugs for neglected diseases of the developing world. Ben Plumley, Vice President of Global Access and Partnerships at Tibotec said, "The future of successfully tackling neglected diseases, such as TB, will be through joint development initiatives between companies and product development partnerships, such as the one we are announcing today with the TB Alliance."
The company is also working with another public-private partnership, the International Partnership for Microbicides, to develop a vaginal microbicide containing the company's antiretroviral drug dapivirine, together with a novel cervical ring that will allow the microbicide to remain active for long periods.