Non-profit drug developer TB Alliance has granted a non-exclusive license to manufacture the anti-TB drug pretomanid to Mumbai-based drugmaker Lupin Limited.

Pretomanid is part of a three-drug regimen BPaL, that includes bedaquiline and linezolid and is used to treat those with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

Business Line had reported that a collaboration with an Indian drugmaker was to be announced early this week.

Pretomanid is also significant as it is the third new drug developed for TB over 40 years, after bedaquiline (from Johnson and Johnson) and delaminid (from Otsuka Pharmaceutical).

Lupin intends to commercialize the medicine in approximately 140 countries and territories, including many of the highest TB burden countries around the world, it said. The company has a history of making TB drugs.

Presently, US generics company Mylan (Viatris), with a base in India and Mumbai-based Macleods Pharmaceuticals make the product here.

Mel Spigelman, President and CEO, TB Alliance said in a statement, “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, Lupin Managing Director, 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.”

India has a high disease burden when it comes to TB, accounting for about one-fourth of the global cases. An estimated 1.5 million people died of TB in 2020, according to the World Health Organization (WHO).

Pointing to collaborations in China and Russia, Dr Spigelmen had told Business Line in a recent podcast, “We would have the whole globe covered from the perspective of ensuring that not only will the drug and the regimen be affordable but it will also be available.” He was responding to a query on access to the drug, something that healthworkers say, is still very limited for reasons of both availability and price.

Read also: TB Alliance to partner Indian firm for global supplies of pretomanid

Watch: TB drugs pipeline: Not a problem of science, problem of resources

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