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Historic trial for tuberculosis launched together by leading drug companies

Two leading pharmaceutical companies, The Global Alliance for TB Drug Development (TB Alliance) and Bayer Healthcare have announced a partnership to coordinate the study to uncover the potential of an existing antibiotic, //Moxifloxacin, to shorten the standard 6-month treatment of tuberculosis (TB).

Mycobacterium tuberculosis infects one-third of the world's population, resulting in nine million new cases of active TB and two million deaths each year. Current TB therapy involves the use of four drugs discovered forty or more years ago and must be given for six to eight months, under the direct observation of a healthcare provider. A shorter protocol is believed to reduce side effects, improve patient adherence to therapy, and save lives.

The trial would examine the effects of substituting moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid). It is hypothesized that the new drug would eliminate TB infection faster than the existing treatment. In vivo preclinical studies have already shown that the drug significantly reduces treatment time by two months. If the trials are successful, the partnership aims to register moxifloxacin for a TB indication and is committed to making it affordable and accessible in developing countries where there is an utmost needed. The trials would take place in Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States and Zambia. Bayer will donate moxifloxacin for each trial site and will cover the costs of regulatory filings. The TB Alliance will coordinate and help cover the costs of the trials. "We are witnessing an historic moment in global health," said Dr. Maria C. Freire, President and CEO of the TB Alliance. "Today, we stand with Bayer, embarking on a major clinical trial program to see if this excellent antibiotic can shorten TB treatment by 2-3 months, which would significantly improve therapy."

"Bayer is committed to working with the TB Alliance to develop a sho rter TB therapy and we are proud to make a tangible contribution and to participate in the movement to achieve the Millennium Development Goal to reverse tuberculosis as a major global health pandemic by 2015." said Dr. Wolfgang Plischke, head of the pharmaceuticals division of Bayer HealthCare.

"This is an important step toward developing a new generation of TB treatments. We urgently need to improve upon current TB drugs, which were developed more than 40 years ago," said Dr. Helene Gayle, Director, HIV, TB and Reproductive Health at the Bill & Melinda Gates Foundation. "By innovating with an existing product, Bayer and the TB Alliance could make an improved TB treatment available much faster than would otherwise be possible."
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