Non-profit drug developer TB Alliance has granted Macleods Pharmaceuticals a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug “BPaL” regimen. Pending regulatory approvals, Macleods has agreed to commercialise the anti-tuberculosis (TB) medicine in approximately 140 countries and territories.
“TB Alliance is committed to ensuring an affordable, sustainable and competitive market for all our new TB products,” said Mel Spigelman, President and CEO, TB Alliance. “We are proud to partner with Macleods, which has a strong record of delivering high-quality, affordable tuberculosis medicines,” Spigelman added.
“Our zeal to bridge unmet needs ensures that we make tomorrow’s medicine available today. This important collaboration with TB Alliance will ensure accessibility of pretomanid in countries where it is needed the most,” said Vijay Agarwal, Director — Business Development, Macleods.
TB Alliance has previously collaborated with Macleods on the introduction of child-friendly formulations of first-line TB medicines. Since its launch in 2015, more than one million treatment courses have been ordered by 94 countries, which represent approximately 95 per cent of the global childhood TB burden.
Further, the Global Drug Facility has announced a price of $364 for a six-month treatment course of pretomanid. The drug was approved for use by the US Food and Drug Administration (USFDA) in August 2019. Médecins Sans Frontières (MSF) is calling on the TB Alliance (TBA) and its commercial partner pharmaceutical corporation Mylan, to further lower the price of this drug, as it is just one part of a regimen of multiple drugs that people need. MSF has been calling for the price of a complete DR-TB treatment course to be no higher than $500 per person.
In light of the price announcement, the lowest global price for a six-month course of BPaL regimen is $1,040, which is double what MSF is calling for.
Researchers from the University of Liverpool have estimated that generic versions of pretomanid could be produced and sold at a profit for less than $1.35 a day, or less than $35 a month.
The high price of one of the other newer TB drugs, bedaquiline, at $400 for a six-month treatment course will also impede the uptake of the BPaL regimen in high TB burden countries. MSF has launched a global campaign calling on pharmaceutical corporation Johnson & Johnson (J&J) to lower the price of bedaquiline to no more than US$1 per day ($200 for six months, or half of what J&J currently charges).
Furthermore, the TB Alliance must also support or carry out research to address outstanding medical questions concerning the safety and efficacy of its drug independent of the BPaL regimen and in comparison to another drug in the same class, as well as its suitability for different populations including children, pregnant women, and people living with HIV receiving the antiretroviral dolutegravir.
According to Sharonann Lynch, HIV & TB Policy Advisor, MSF Access Campaign,“Newer TB drugs, including pretomanid, may have tremendous potential for tackling difficult-to-treat drug-resistant forms of TB, but only if they are affordable. The high price of this drug could have a chilling effect on its uptake in high TB burden countries.
We are calling on Mylan and the TB Alliance to bring the price of pretomanid down much further, so that the TB Alliance can hold true to its stated mission of developing and making improved TB medicines accessible to people who need them.”
Lynch further said, “After half a century, we finally have new TB drugs that can offer a better chance of survival for people who otherwise continue to die from the world’s leading infectious disease killer. The public helped pay for the development of this drug, and therefore, this drug should be affordable and accessible to anyone who needs it. What good is a lifesaving drug if the people who need it can’t afford it?”