Bayer Joins TB Battle - Pharmaceutical Technology

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Bayer Joins TB Battle

ePT--the Electronic Newsletter of Pharmaceutical Technology

Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China’s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.

"We have decided to make moxifloxacin available to provide quick support to those patients in need," Jörg Reinhardt, chairman of the board of management of Bayer HealthCare, said in a statement. "We were happy to follow the request from WHO because we believe that this is the right step to address an increasing medical need in patients affected with this serious disease and for whom there are only very limited oral treatment options available."

According to Bayer, multidrug-resistant TB does not respond to standard TB drugs and can take two years or longer to cure. “Some countries, especially the former Soviet Union, China and India, have a high incidence of multidrug-resistant TB,” explained Bayer. “According to WHO, an estimated 440,000 multidrug-resistant TB cases and 150,000 deaths occurred in 2008. Multidrug-resistant TB occurs almost everywhere in the world, the main focus being in Asia. Nearly half of multidrug-resistant TB cases are estimated to occur in China and India.”

The medicine provided by Bayer, moxifloxacin, is a broad-spectrum antibiotic, but is not approved for the treatment of TB or multidrug-resistant TB. However, WHO has included the medicine in treatment group III of its guidelines as part of a second-line TB regimen in patients with confirmed multidrug-resistant TB. Moxifloxacin will be administered in China in a highly controlled manner, with close monitoring.

“Together with the Global Alliance for TB Drug Development, Bayer’s pharmaceutical division is working on the development of moxifloxacin as a treatment for drug-susceptible pulmonary TB. It is the aim of ongoing studies to show that use of moxifloxacin could reduce the length of treatment for drug-susceptible TB from six to four months. Bayer HealthCare intends to apply for the approval of moxifloxacin for the treatment of pulmonary TB as soon as clinical trials have been completed,” said Bayer.

The TB partnership, Stop TB, was formed by WHO in 2001, and comprises a network of international organizations, countries, donors from the public and private sectors, and governmental and nongovernmental organizations.

This is the second boost that China has had in recent weeks with regards to TB treatments. Last month, the Stop TB Partnership also announced that Aeras, a US-based product development organization and a member of the program’s Working Group on New TB Vaccines, had signed a memorandum of understanding with the China National Biotech Group, with the aim of pursuing opportunities to jointly develop TB vaccines in China. Potential activities will cover the full spectrum of product development, including preclinical development, process development and manufacturing, and clinical development in TB.

According to Aeras, TB is a major public health priority in China where there are more than one million new TB cases every year. Globally, TB is reported to be responsible for 1.7 million deaths every year.


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