TB Alliance and Lupin Announce Commercial Partnership for New Therapy for Highly Drug-Resistant TB

Agreement between non-profit product development partnership and multinational pharmaceutical company will expand access to new TB drug

NEW YORK and MUMBAI (September 6, 2021)—Non-profit drug developer, TB Alliance has granted global pharma company, Lupin Limited (Lupin), a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug “BPaL” regimen. Lupin intends to commercialize the anti-tuberculosis (TB) medicine in approximately 140 countries and territories, including many of the highest TB burden countries around the world. 

“TB Alliance is committed to ensure its products are widely available and affordable to those who need them,” said Mel Spigelman, president and CEO, TB Alliance. “Partnering with Lupin, a well-established manufacturer with experience delivering high quality TB therapies, will help further enable widespread access to our novel regimen while promoting a competitive market to drive affordability.”

Nilesh Gupta, Managing Director, Lupin added, “As a global leader in anti-TB medicines, Lupin is committed to enhancing access to bridge unmet needs in countries where it is needed the most. This collaboration with TB Alliance leverages our strength and expertise to contribute to better global health.”

Naresh Gupta, President API Plus, at Lupin added, “Tuberculosis is one of humanity’s oldest, deadliest, and most persistent diseases. Lupin is the largest supplier of first-line anti-TB drugs in the world, and we are excited to partner with TB Alliance to help bring new therapies for highly drug-resistant TB to reach individuals and countries where access to these medicines is so urgently needed.”

About Tuberculosis
TB, in all forms, must be treated with a combination of drugs; the most drug-sensitive forms of TB are typically treated for six months using four anti-TB drugs. An estimated 1.5 million people died of TB in 2020, according to the World Health Organization (WHO), although the precise numbers are not known and recent research suggests that TB could have killed as much as half a million more people in that same year.1

Drug-resistant TB develops when the long, complex, decades-old TB drug regimen is improperly administered, or when people with TB stop taking their medicines before the disease has been fully eradicated from their body—highlighting the urgent need to develop better and shorter treatment regimens. Once a drug-resistant strain has developed, it can be transmitted directly to others through the air, just like drug-sensitive TB. There are over half a million cases of drug-resistant TB each year and its spread undermines efforts to control the TB pandemic.

About TB Alliance
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. 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. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Germany’s Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (Korea), Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Korea International Cooperation Agency, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Diseases, Netherlands Ministry of Foreign Affairs, Republic of Korea’s Ministry of Foreign Affairs, and the United States Agency for International Development. For more information, visit http://www.tballiance.org

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. In FY2021, the Company invested 9.6% of its revenues on research and development.

Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
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TB Alliance Welcomes New Data on BPaL-Based Regimens Presented at the 2021 Union Conference

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New Trial Results Show Effectiveness of BPaL Regimen for Highly Drug-Resistant TB Can Be Maintained with Reduced Dosing of Linezolid