TB Alliance Licenses Late-stage TB Program to CSIR-OSDD

OSDD to assume development, commercialization for promising TB regimen

March 19, 2013

TB Alliance, an international non-profit organization which develops better, faster-acting, and affordable TB drugs, has announced that it has granted a license to and is working with the Open Source Drug Discovery (OSDD) programme of Council of Scientific and Industrial Research (CSIR) to develop and commercialize a promising new tuberculosis (TB) regimen for use within India. CSIR is an Indian governmental institution, which provides scientific and industrial R&D that maximizes the economic, environmental, and societal benefits for the people of India.

Each year, TB affects 2.3 million people in India, which has the highest rates of TB in the world. Today’s current TB treatments are growing increasingly resistant to available drugs and new tools are urgently needed. The license enables CSIR to undertake the research that is urgently needed to advance this late-stage development program in India. This is the first Indian-sponsored clinical research of a novel TB regimen.

“The Open Source Drug Discovery program aimed at the discovery and development of new drugs for TB patients is reflective of the Government of India’s commitment towards neglected diseases,” says Mr. S. Jaipal Reddy, Minister of Science & Technology, Government of India. “If the new regimen clears clinical trials, it would be made available to the Indian TB patients at an affordable cost.”

“There is an urgent need to develop new shorter regimens for TB treatment to help arm clinicians in the fight against the pandemic,” says Samir K. Brachmachari, Director General CSIR. “CSIR is playing a leading role in conducting this trial and supporting the development of innovative new treatments for tuberculosis.”

CSIR will assume responsibility for the development and commercialization of the PaMZ regimen in India. This regimen, which consists of the novel compound PA-824, a fluoroquinolone, moxifloxacin, and pyrazinamide has shown potential to shorten treatment, including for some forms of drug-resistant TB. The TB Alliance has licensed the treatment regimen to CSIR in India and, if successful, CSIR agrees to make the treatment available to the people of that country at the lowest cost possible.

“This initiative highlights the commitment on the part of the Indian government to invest in the health of its people by finding new tools to tackle TB,” said Mel Spigelman, MD, President and CEO of TB Alliance. “CSIR is well positioned for the clinical development and commercialization of this regimen in India, including leveraging the country’s substantial pharmaceutical and manufacturing industries. Other countries can view this as a model and pathway to expand and expedite new TB drug development.”

CSIR-OSDD will initiate a Phase 2b trial, which is an 8-week trial to test efficacy of the PaMZ regimen. If the results of that trial are successful, CSIR-OSDD will then invest in a Phase 3 trial—a significant undertaking that will determine if the regimen could be introduced for the benefit of patients in India.

If successful, the results of this research will pave the way for the development of a simple, safe and patient-friendly regimen. Currently, TB treatment lasts 6 months and MDR-TB can last up to 30 months and includes one injectable. The PaMZ regimen shows promise to reduce treatment time for drug-sensitive and many forms of drug-resistant TB to 4 months.

The Phase 2b trial will be carried out at the Lala Ram Swarup Institute of TB and Respiratory Diseases, an OSDD partner, in New Delhi. TB Alliance will continue to develop the PaMZ regimen outside of India and for use in other countries around the world. Both entities will share information and learnings from the development of the regimen.

About the Council of Scientific and Industrial Research (CSIR) Open Source Drug Discovery Program (OSDD):

Council of Scientific and Industrial Research (CSIR) is an autonomous society whose President is the Prime Minister of India. CSIR is an ensemble of 37 laboratories in engineering, physical, biological, chemical and information science clusters, funded chiefly by the government of India. CSIR laboratories engage about 5000 scientist and almost 10000 students pursuing higher degrees.

Open Source Drug Discovery (OSDD) is an initiative funded and led by the Council of Scientific and Industrial Research, an autonomous body under the Government of India. CSIR provides scientific and industrial R&D that maximizes the economic, environmental and societal benefits for the people of India. OSDD is a team India consortium with global partnership with a vision to provide affordable healthcare to the developing world to solve the complex problems associated with discovering novel therapies for diseases like Tuberculosis, Malaria and Leishmaniasis.

For more information please visit www.osdd.net

About TB Alliance:

The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, Irish Aid, UK aid, National Institute of Allergy and Infectious Disease, UNITAID, the United States Agency for International Development, and the United States Food and Drug Administration. For more information, please visit tballiance.org.