Unique Collaboration Between TB Alliance and Tibotec to Accelerate Tuberculosis Drug Development
Collaboration Will Focus on the Development of TMC207 and the Discovery of New Drugs to Treat Tuberculosis
June 17, 2009
Seattle, Wa. -- A new landmark collaboration between the Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership, and Tibotec Inc., (Tibotec), a global pharmaceutical company, has been announced today at the Pacific Health Summit in response to the urgent need to accelerate the discovery and development of new drugs to fight tuberculosis (TB).
The two organizations will 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. The interim data from an ongoing Phase II study of TMC207 were recently published in the New England Journal of Medicine. In the placebo-controlled study of 47 patients with multidrug-resistant TB (MDR-TB), it was found that 48 percent of patients receiving TMC207 in combination with standard treatment converted to negative sputum culture after eight weeks compared with 9 percent of those who received placebo and standard treatment.
The collaboration will maximize the expertise and resources from both the public and private sectors with the intent to improve the treatment of one of the world's oldest and most deadly diseases. Increased efforts and resources to develop new and improved TB drugs are sorely needed. Among infectious diseases, tuberculosis is the second most common cause of adult deaths worldwide.1 The World Health Organization (WHO) estimates approximately one-third of the world's population is infected with Mycobacterium tuberculosis (M.tb), the bacillus that causes TB,2 and the disease is responsible for nearly 5,000 deaths per day, worldwide.3 MDR-TB, which is characterized by resistance to at least two of the most powerful medicines in today's standard, four-drug regimen for drug-susceptible TB, is of particular concern given the rapid rise in the number of cases throughout the world and the difficulties in treating it. There were an estimated 510,000 incident cases4 and 130,000 fatalities due to MDR-TB in 2007.5 The Pacific Health Summit is focusing on MDR-TB at this year's conference because of the growing public health threat it poses.
"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 CEO. "Since the TB Alliance was founded, we have assembled the largest pipeline of new TB drugs in history, but this progress is only possible with the commitment of our partners. Tibotec has tremendous scientific prowess, a commitment to fighting infectious diseases, and is an essential long-term partner in our fight to end one of the greatest epidemics of our time."
Under the terms of the agreement, Tibotec will continue to develop TMC207 for the treatment of MDR-TB, and on approval, will establish an access program to ensure the compound reaches those in developing countries who are 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. In addition, Tibotec will collaborate with the TB Alliance on a discovery research program to identify 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. Costs for the development of TMC207 will be shared.
"To make a meaningful contribution to the global fight against TB, we knew we had to take a novel approach. Our collaboration with the TB Alliance represents a major step forward in the fight against TB as the two organizations combine their expertise and resources in the quest to make new TB treatments available," said Dr. Paul Stoffels, Global Head of Pharmaceutical Research and Development, 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."
This announcement marks the first collaboration initiated by the newly created Tibotec Global Access and Partnerships Program. The program is creating a sustainable portfolio of medicines -- both marketed and in development -- that are designed to address major health challenges in resource-poor countries. Ben Plumley, Vice President of Global Access and Partnerships 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."
Product development partnerships (PDPs), such as the TB Alliance, build partnerships linking the public, private, academic, and philanthropic sectors. The TB Alliance combines the research and development proficiency of its own staff with the skills and resources of its partners to streamline and optimize TB drug development.
TMC207 was discovered by scientists at Janssen Pharmaceutica N.V., which signed the collaboration agreement with the TB Alliance, and is being developed by its affiliate Tibotec. In vitro studies show that it is highly active against Mycobacterium tuberculosis (M.tb). TMC207 has a unique mechanism of action targeting adenosine triphosphate (ATP) synthase,6 which M.tb requires to generate its energy supply. Currently, TMC207 is being studied in a Phase II clinical trial in people with MDR-TB. The safety and efficacy of TMC207 has not yet been established.
This article was provided by Tibotec, Inc..