Poised for the next wave of innovation, tuberculosis drugs are unlikely to mimic the pricing ‘disaster' witnessed globally in the HIV/AIDS drugs segment, says Dr Melvin K. Spigelman, President and Chief Executive of TB Alliance.

There has been a global effort to make new TB drugs affordable, he said, adding that stakeholders in the segment, including drug-makers, had met last month in Geneva on the issue.

Lessons have been learnt from the pricing ‘disasters' of HIV drugs, Dr Spigelman, told Business Line , adding that drug-makers have realised the ‘social component' involved in developing multi-drug resistant (MDR) TB drugs. The TB Alliance is a 10 year-old not-for-profit organisation involved in the discovery and development of fast-acting drugs for TB.

Global campaigns

In a sense, “HIV paved the way on how to solve these problems,” he said, referring to the hi-profile global campaigns for affordable HIV/AIDS medicines — where low-cost generic drug-makers constantly lock horns with multinational drug-makers. In fact, way back in 2001, generic drug-maker Cipla had taken the price battle into Africa, when it offered generic HIV drugs at reduced prices.

Innovative or patent-protected TB drugs are slated to be rolled out in the global market starting next year, over the next couple of years, Dr Spigelman said. Johnson and Johnson-company Tibotec and Japanese drug-maker Otsuka, are some of the companies with next-gen TB drugs in the pipe-line, he said, besides Astra Zeneca and efforts in the segment by Pfizer.

Patents allow the patent-holder to exclusively sell the drug for 20 years, following which it becomes a generic drug. At present, the TB drug market is generic, he added.

There is a middle-ground to work on, he said, adding that companies can make their profits, even as they keep medicine prices affordable. The TB Alliance has also helped de-risk the high cost in drug-development by getting donors to fund the process, he said.

Resistance worries

The real worry is on appropriate use of the new TB drugs, so that they do not spawn resistance, he said. Multi-drug resistance (MDR) is a problem facing people with TB — caused by previous ineffective or hap-hazard treatment of the illness. Since the treatment regimen is over six months, patients sometimes do not stick to it, resulting in resistance building in them against the drug.

According to data with the TB Alliance, he said, it appears that more TB drugs were sold in the private market. This could be because of hap-hazard treatment, non-adherence to treatment regimen or there were more number of people with TB than estimated (possibly because the private market did not disclose details, fearing possible stigma associated with the illness).

Scouting for partners

Though the TB Alliance works with Astra Zeneca's research facility in Bangalore, it is seeking several more such alliances for clinical development of new drugs, Dr Spigelman said. The TB Alliance has been in talks with Chennai's TB Hospital, he said, adding that they were looking for several more sites to collaborate within India.

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