Mumbai Pharma Company Gets Licence for Breakthrough TB Drug

MUMBAI: In a move which will make treatment of tuberculosis (TB) simpler, accessible and affordable, global non-profit drug developer TB Alliance has tied up with domestic company Macleods Pharmaceuticals to develop and commercialise its ‘breakthrough’ drug Pretomanid in high-burden countries, including India.

Pretomanid is an important drug for the treatment of highly drug-resistant TB (DR-TB), if taken along with other TB medicines. It is also the third new anti-TB drug approved by USFDA in over 40 years. Significantly, Macleods has now become the second generic manufacturer for the drug, globally, after the TB Alliance earlier granted rights to US drug maker Mylan in August this year.

Drug resistance is a major public health crisis thwarting the effective treatment of tuberculosis and India has the highest number of TB and DR-TB patients in the world.

The licence granted to the Mumbai-based company puts to rest doubts about the access and affordability of the new drug which when used in combination (with other drugs), can cut the duration of the treatment for drug-resistant TB from 18-24 months to six-nine months.

Details regarding the drug’s pricing are yet to be worked out.
When contacted, Mel Spigelman, president and CEO, TB Alliance told TOI, “The licensing agreement with Macleods will allow the company to market Pretomanid as part of the BPaL (regimen consisting of bedaquiline, pretomanid and linezolid) in approximately 140 countries, which represents the vast majority of the global TB burden”.

“This new addition to Macleods’ existing anti-TB products portfolio, will lead to more people getting access to this essential medicine in countries where it is needed the most,” Vijay Agarwal, business development director at Macleods, said.
There is a growing resistance to certain existing drugs (implying the disease is becoming deadlier and more difficult to treat). Multidrug resistant (MDR) and extensively drug resistant (XDR) TB are forms of the disease caused by bacteria that do not respond to first-line anti-TB drugs. Existing treatments, therefore, consist of combinations of many different drugs, which is required to be taken for two years (approximately). Patients may take as many as 20 pills a day, resulting in numerous side-effects and a huge economic burden.
Regarding the agreement with Mylan, Spigelman said the company has submitted a new drug application to the office of Drug Controller General of India (DCGI) and is an advanced stage of discussion to expedite the product. The US company holds non-exclusive rights to market the drug in India.

In August, US Food and Drug Administration (FDA) approved the use of new TB drug Pretomanid as part of a regimen. Besides, Pretonamid, in half a century, only two new drugs have been developed and approved to DR-TB patients : bedaquiline and delamanid.The two pretomanid-based regimens under development include — for XDR-TB and MDR-TB that is treatment-intolerant or non-responsive — all oral, six to nine month treatment regimen consisting of bedaquiline, pretomanid and linezolid (BPaL regimen), and for DS-TB and MDR-TB: All oral, four and six month treatments, respectively, consisting of bedaquiline, pretomanid, moxifloxacin and pyrazinamide (BPaMZ regimen).
According to the World Health Organization, in 2016, there were an estimated 490,000 new cases of multidrug-resistant TB worldwide, with a smaller portion of cases of extensively drug-resistant TB.

Source: ToI

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