TB Alliance to partner Indian firm for global supplies of pretomanid

An Indian drugmaker has been roped-in by TB Alliance to make its tuberculosis drug pretomanid and strengthen global supplies. The collaboration is expected to be announced early this week.

TB Alliance is a non-profit drug developer and its pretomanid is the third new drug developed for TB in over 40 years, after bedaquiline (from Johnson and Johnson) and delaminid (from Otsuka Pharmaceutical). In a recent podcast with BusinessLine, TB Alliance’s President and Chief Executive, Dr Mel Spigelman, had indicated that a collaboration was in the offing with an Indian drugmker to shore-up global supplies. “We will be very shortly announcing a third company in India...who will also be manufacturing and distributing, not just for India. It’s a global company, to actually sell around the world,” he said.

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Pretomanid is part of a three-drug regimen that includes bedaquiline and linezolid and is used to treat those with extensive drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB), who are treatment-intolerant or non-responsive. Presently, US generics company Mylan (Viatris), with a base in India and Mumbai-based Macleods Pharmaceuticals make the product here.

Availability

Pointing to collaborations in China and Russia, he added, “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.” Dr Spigelman 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. TB Alliance representatives were working on ironing-out details to further help the roll-out of the regimen, he said.adding, “Mylan will be donating many courses of treatment to India ...so I don’t believe the affordability will be an issue at all.” Further, he explained, since the drug development programme had not involved patients from India, officials may be hesitant to use a treatment across the whole country before it was used in that specific patient population. “We are working on that also with the government and the national TB programme to get usage started in India so that Indian physicians and programmes can actually have first-hand experience with the three drug regimen..”, he said, although two of the medicines in the three-drug course are familiar to the medical community.

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