TB Alliance and Bayer Launch Historic Global Drug Trials for Tuberculosis

NEW YORK, and LEVERKUSEN, Germany -- The Global Alliance for TB Drug Development (TB Alliance) and Bayer Healthcare AG today announced a partnership to coordinate a global clinical trial program to study the potential of an existing antibiotic, moxifloxacin, to shorten the standard six-month treatment of tuberculosis (TB).

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 patients need it most. The trials will take place in Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States and Zambia.

The Phase II clinical trial program spans four continents and will enroll close to 2,500 patients with TB. 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, leveraging substantial support from the Centers for Disease Control and Prevention (CDC), the Orphan Products Development Center of the Food and Drug Administration (FDA) and the European and Developing Countries Clinical Trials Partnership (EDCTP).

"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 two to three months, which would significantly improve therapy. If successful, a new, shorter regimen could be available in the next five years, making the difference between life and death for millions of TB patients."

The trials will evaluate whether the substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than the current standard therapy.(1) Current TB therapy is based on four drugs discovered forty or more years ago that must be administered for six to eight months, often under the direct observation of a healthcare provider. Preclinical studies in vivo(1) showed moxifloxacin reduced treatment time by two months when substituted for isoniazid, a cornerstone drug of TB treatment.(2) Moxifloxacin is approved in 104 countries to treat certain

bacterial respiratory and skin infections.

"Moxifloxacin has been safely and reliably used to treat millions of patients with a variety of bacterial respiratory tract infections," said Dr. Wolfgang Plischke, head of the pharmaceuticals division of Bayer HealthCare. "Bayer is committed to working with the TB Alliance to develop a shorter 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."

Mycobacterium tuberculosis infects one-third of the world's population, resulting in 9 million new cases of active TB and 2 million deaths each year. Public health experts note that a shorter TB regimen would help ease the economic burden, estimated at $16 billion a year, and enable healthcare workers to treat more patients. A shorter protocol could also reduce side effects, improve patient adherence to therapy, and save lives. When patients

complete treatment successfully, there is a lower chance of relapse and the emergence of drug resistance.

Two clinical trials are being conducted by the Tuberculosis Trials Consortium (TBTC) of the CDC, represented by Steering Committee Chair Dr. Neil Schluger of Columbia University. Principal investigators of the two other trials are Dr. Richard Chaisson of the Johns Hopkins University and Dr. Stephen Gillespie of the University College London, working with professor Andrew Nunn of the British Medical Research Council.

Current projections of TB incidence and mortality reflect the need for shorter, more effective TB therapy. An estimated 1 billion people will be newly infected between 2000 and 2020, 200 million will fall ill and 35 million will die. TB is a leading cause of death among people living with HIV/AIDS, and multi-drug resistant strains are spreading at a rate of 300,000 newly diagnosed cases a year.

References:

1. Preclinical activity in animals does not necessarily imply clinical

          effectiveness in humans.

2. Nuermberger, EL et al. Moxifloxacin-containing regimen greatly

          reduces time to culture conversion in murine tuberculosis. American

          Journal of Respiratory and Critical Care Medicine 2004;

          169: 421-426.

Source: Bayer Healthcare AG