Battle for bedaquiline

April 9, 2019 0 By S Harachand

Bedaquiline is the first anti-TB drug developed in over four decades. The cost of the treatment goes up to $30,000 for a six-month course.

A diarylquinoline antimycobacterial agent, bedaquiline’s cure rates for patients have been reported at over 80%.

]The drug also has fewer side-effects compared to the old anti-TB injectable drugs which can even cause deafness.

By 2016, at least 35 countries have introduced shorter regimens for treatment of MDR/RR-TB and 89 countries and territories had started using bedaquiline, shows WHO Global TB Report 2017.

Nevertheless, the drug still remains out of reach for most low- and middle-income countries. To date, only 25,000 people around the world have received bedaquiline and two-thirds of these patients have been in South Africa. South Africa is among those small number of countries which have negotiated a greatly reduced price of $400 from Johnson & Johnson, the maker of the drug.

The drug maker Johnson & Johnson, in its latest filing, seeks extended patent protection to bedquiline in India. The company›s current patent expires in 2023. If granted, the drug will enjoy exclusive marketing rights till 2027.

Since India is considered the hub of generic medicines of the world, the additional patent could further delay the availability of low-priced versions of this life-saving medicine and will also indirectly impact many countries in the world, say those opposing the patent in India.

Activists demanded J&J to slash the price for the blockbuster tuberculosis drug at the opening of 49th Union World Conference on Lung Health in the Netherlands in October last year.

There is a greater chance of curing MDR-TB patients who otherwise look at an abysmal cure-rate of 50 percent, but this can only happen if J&J cuts the price for bedaquiline to a dollar a day, they maintained.

J&J said in a statement that their new price of $400 per course is “genuinely a special effort that we set to encourage rapid scale-up of bedaquiline in countries with a high TB burden”.

Controversies over pricing have the potential to further damage an already fragile environment for TB research and development.

Since its approval as part of USFDA’s Fast Track accelerated approval process in 2012, J&J has donated 60,000 bedaquiline treatments to patients in such high-TB-burden countries as China, India and South Africa, the company said.

In 2017, J&J formed a collaboration with India’s Institute of Microbial Technology (IMTech), focused on discovering safer, more effective oral treatments and multi-drug regimens for MDR-TB.

J&J has tied up with the International Union Against Tuberculosis and Lung Disease to include bedaquiline in the STREAM study, a multicentre international trial to evaluate the medicine in patients with MDR-TB. Final study results are expected as early as 2023.