Bayer HealthCare has agreed to support the World Health Organization (WHO) and the Stop TB Partnership in the fight against multidrug-resistant tuberculosis (MDR-TB) by making 620,000 tablets of the antibiotic moxifloxacin available to WHO. Through the Stop TB Partnership's Global Drug Facility, WHO will provide the antibiotics to China's national TB programme.
"We have decided to make moxifloxacin available to provide quick support to those patients in need", said Dr. Jörg Reinhardt, Chairman of the Board of Management of Bayer HealthCare. "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."
"We are grateful to Bayer for making moxifloxacin available for use in China. This medicine will ease the suffering of people with drug-resistant TB and contribute to preventing many deaths," said Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership.
Moxifloxacin is a broad-spectrum antibiotic indicated for treatment of several acute bacterial infections, such as respiratory tract infections. Bayer HealthCare must emphasize that currently moxifloxacin does not have approval for the treatment of TB, including multidrug resistant tuberculosis. However, WHO has included moxifloxacin in treatment group 3 of its guidelines as part of a second-line TB regimen in patients with confirmed MDR-TB on the grounds of its demonstrated activity against Mycobacterium tuberculosis (Mtb). Through the cooperation with the WHO/Stop TB Partnership moxifloxacin will be administered in China in a highly controlled manner, with close monitoring by the Green Light Committee.
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 tuberculosis (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.
Bayer HealthCare does not recommend that moxifloxacin be used outside of its approved indications, including in the treatment of multidrug resistant tuberculosis. It should not be used for the treatment of MDR-TB outside of MDR-TB treatment programs authorized and monitored by the Green Light Committee and under the responsibility of WHO/Stop TB Partnership in cooperation with China's public health authorities. The agreement with the WHO includes stringent pharmacovigilance requirements to ensure that patients are treated in the non-approved indication in an ethically and medically appropriate manner.
About TB and drug-resistant TB
TB occurs all over the world and causes more than nine million illnesses and almost two million deaths a year. Multidrug-resistant TB (MDR-TB) is a particularly dangerous form of TB caused by bacteria that are resistant to isoniazid and rifampicin, two of the most effective anti-TB drugs.
Drug-resistant TB is caused by factors such as inconsistent or partial treatment, inadequate patient adherence, doctors prescribing the wrong treatment regimens, or the inadequate supply or quality of drugs. MDR-TB can result from a primary infection with resistant bacteria or it may develop during ineffective treatment of drug-sensitive TB. It can also be transmitted from person to person. MDR-TB does not respond to the standard six-month treatment with first-line anti-TB drugs, and can take up to two years or longer to cure. Some countries, especially the former Soviet Union, China and India, have a high incidence of MDR-TB. According to WHO, an estimated 440,000 MDR-TB cases and 150,000 deaths occurred in 2008. MDR-TB occurs almost everywhere in the world, the main focus being in Asia. Nearly half of MDR-TB cases are estimated to occur in China and India.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries.
About the Stop TB Partnership
The Stop TB Partnership is leading the way to a world without tuberculosis (TB). It includes more than 1600 organizations, all committed to fighting a disease that is curable but still kills three people every minute.
Partners are a collective force that is transforming the fight against TB in more than 100 countries. They include the World Health Organization - which hosts the partnership secretariat and is a major partner -, government programmes, technical partners, research and funding agencies, NGOs, civil society and community groups and private sector. The Global Plan to Stop TB 2011-2015 sets out a shared goal: to halve TB deaths by increasing the number of people tested and treated, and by developing new diagnostics, vaccines and drugs.
About the Global Drug Facility
The Global Drug Facility (GDF) is an initiative to increase access to high quality tuberculosis (TB) drugs for DOTS implementation, a TB control strategy. Globally, TB is the leading curable cause of death from infectious disease. The GDF is housed in WHO headquarters in Geneva and managed by a small team in the Stop TB Partnership Secretariat.
About the Green Light Committee
The Green Light Committee (GLC), a joint initiative of WHO and the Stop TB Partnership, helps countries gain access to high-quality second-line anti-TB drugs so they can provide treatment for people with MDR-TB in line with the WHO guidelines, the latest scientific evidence and country experiences.