TB Alliance and CSIR-OSDD Partner to Support TB Drug Development in India

Agreement plans to leverage extensive Indian clinical trial network

March 22, 2012

New Delhi, India - In advance of World TB Day and on the heels of news of outbreaks of deadly drug-resistant TB in India, the Council of Scientific and Industrial Research (CSIR), which provides scientific and industrial R&D that maximizes the economic, environmental and societal benefits for the people of India, announced today a Memorandum of Understanding between its Open Source Drug Discovery (OSDD) initiative and the TB Alliance, an international non-profit organization which develops new, faster-acting, and affordable TB drugs

TB is a leading global killer, but its impact is felt hardest in India. WHO estimates that each year, 2.3 million people in India contract TB, and 320,000 die from the disease. The current treatment is old and inadequate, which is fueling the growth of drug-resistant TB. India has the highest prevalence of drug-resistant TB. Nearly 100,000 patients in India suffer from multidrug-resistant TB (MDR-TB). Recent reports of 12 cases of a new class of Extensively Drug Resistant (XDR-) TB made national and international headlines.This has raised serious concerns amongst the clinicians treating TB who see themselves unarmed with drugs that can fight MDR- and XDR-TB. There is an urgent need to bring new drugs for treatment of TB.

“Today, there are a few new TB drugs being developed around the world, and it’s critical for India—which has the world’s highest burden of tuberculosis—to bring new drugs to its patients. OSDD will play a leading role in supporting and furthering innovation.” says Prof Samir K Brahmachari, Director General CSIR and Chief Mentor OSDD. “CSIR is able to leverage its platform in this collaboration with the TB Alliance to ensure new TB drugs are developed right here in India,so that patients can receive these desperately needed life-saving treatments as soon as possible.”

CSIR has already been working on the area of TB. CSIR in collaboration with Cadila Pharma has developed a new drug formulation ‘Risorine’ which enhances the bio-availability of Rifampicin, eliminating the need for high doses of the drug.

New, faster-acting, and more effective TB regimens are urgently needed to help India control the TB epidemic, prevent the growth and spread of drug resistance, and stop needless deaths. The Memorandum of Understanding will pave the way for clinical trials to be conducted in India through publicly funded institutions which are part of CSIR-OSDD’s extensive network of collaborators. The TB Alliance will contribute to the collaborationby bringing new TB drugs and regimens that are currently in its pipeline and show promise to treat both drug-sensitive and drug-resistant disease. These novel drugs or combinations of drugs that may ultimately gain regulatory approval will be available in India at affordable costs to the patients keeping with both organizations' missions.

Currently, someone with drug-sensitive TB must take a course of drugs for six months, while those with MDR-TB must take an injection along with a number of drugs for the first six months and continue that drug treatment for 18 months or longer. Around the world, many patients fail to complete treatment because they cannot tolerate the difficult side effects of the medications and fail to adhere to the long treatment. This leads to the development of drug resistance. Once infected with drug-resistant TB, that disease can be spread directly to others. Treatment of drug-resistant TB is exponentially more difficult and expensive than treatment of drug-sensitive TB. Of the small numbers of patients who are able to access appropriate treatment, mortality of 1 in 3 is common.

“TB is a growing problem in India that cannot be solved without new, faster-acting, and affordable drugs,” said Mel Spigelman, MD, President and CEO, TB Alliance. “We applaud CSIR-OSDD for leading this collaboration and leveraging its considerable network and resources to help address a crisis that impacts the health and development of India and the entire world.”

“The OSDD model is of particular importance for pubic health for two reasons. One, it addresses real needs related to Tuberculosis, which is a major public health problem. Second, it opens the way for a model of innovation that combines the twin merits of innovation and affordability.” said Dr Amit Sen Gupta of Jan Swasthya Abhiyan, a leading nongovernmental organization in the field of affordable healthcare.

“Neglected diseases like tuberculosis need to be given special attention at every level,” says Dr D. Behera, LRS Institute of Tuberculosis and Respiratory Disease. “We commend international collaborations like this partnership between CSIR-OSDD and TB Alliance, which should hasten the development of urgently needed new therapies. The government, regulators, and other stake holders all need to join in to ensure the mechanisms are in place not only to develop new treatments, but hasten the process of getting these cures registered and to the patients who need it the most”

New TB treatments are a critical piece of a comprehensive and long-term solution to the scourge of tuberculosis. Advances in TB vaccines and diagnostics, as well as improved case management practices are all areas which need further investment to help stem the TB epidemic in India and around the world on an urgent basis.

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 the Global Alliance for TB Drug Development (TB Alliance):

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, the United Kingdom Department for International Development, the United States Agency for International Development, and the United States Food and Drug Administration.