For a long time the medical community believed that tuberculosis was on the decline, controlled successfully by modern medicine. In fact, nine million new cases of active tuberculosis are recorded every year, and the WHO estimates that 1.5 million people die of it every year – people who have no access to modern medicine. This is because tuberculosis is primarily a disease that affects the poor. Bayer is collaborating with the Global Alliance for TB Drug Development (TB Alliance) to develop a new tuberculosis drug in an effort to change this situation.
"We are witnessing an historic moment in global health," said Dr. Maria C. Freire, President and CEO of the TB Alliance at the beginning of the joint project. "If our worldwide clinical trial program with Bayer is successful, a new, shorter regimen could be available in the next five years. This can make the difference between life and death for millions of TB patients."
Prof. Dr. Wolfgang Plischke, the former head of the Pharmaceuticals Division at Bayer HealthCare and currently a member of the Board of Management of Bayer AG, is confident that moxifloxacin can be applied to TB: "We are proud to be working with the TB Alliance towards the goal of controlling tuberculosis, one of the major pandemic infectious diseases."
If the study confirms observations made at the pre-clinical stage, moxifloxacin combined with other existing medicines could replace the current standard medication for tuberculosis. This would have a number of advantages for patients. The infection is cured faster when treated with moxifloxacin, reducing the duration of therapy – which is currently at least six months – by at least one-third. A shorter period of treatment means that patients suffer fewer side effects and increases their willingness and their financial ability to continue treatment for the duration necessary to cure the disease. This is particularly important, because terminating therapy prematurely increases the risk of multi-drug resistant strains of bacteria emerging.
New drugs to combat tuberculosis need to be many things at once: efficient, fast-acting, capable of overcoming resistant bacterial strains, and suitable for treating patients who are also infected with HIV – TB is the leading infectious cause of death in HIV patients – and cheap enough for their use in developing countries, in particular, to be common practice. The results from the study are expected in 2010. If it is successful, an application will be submitted for the approval of moxifloxacin for the tuberculosis indication in the U.S., Europe and the countries where the disease is endemic. Together with the TB Alliance, we will advocate making moxifloxacin available to tuberculosis patients at affordable prices, especially in developing countries with a high disease burden.