Come 2023, US drug major Johnson and Johnson’s patent over the crucial anti-tuberculosis drug Bedaquiline will expire. In an interview with BusinessLine on the sidelines of the 50th Union World Lung Health Conference , Sarthak Ranade, Managing Director, Janssen India, the pharma arm of J&J, said that generic manufacturers can produce the drug in four years after the patent expires. He said that there was misinformation that J&J was trying to block the patent from expiring. Excerpts:

The scourge of drug-resistant tuberculosis in India is huge. How do we tackle it?

Drug resistance is becoming a big issue. We brought out Bedaquiline that works against multi-drug-resistant TB. But, how do we holistically tackle this disease? It is all about adherence, the patient has to take full therapy, but when we start feeling well, we stop taking drugs.

Bugs are finding a mechanism to fight and come back with a lot of vengeance. Also, if you want to make the new drugs work, you need to have a patient body that can handle these drugs; so nutrition is the key. We are supporting nutrition in 6,000 patients, working with the help of non-profits.

What are you doing to improve access as there is limited availability of the drug?

In 2012, Bedaquiline was approved globally and we started the global compassionate use programme in 2013. Then, we provided 600 courses to the government, and over the last three years in co-ordination with USAID, we have donated 22,000 courses.

We need 56,000 courses annually and according to the World Health Organisation’s recommendations, Bedaquiline features as a top drug for MDR-TB treatment. But we are unable to reach that population

The new guidelines have just been rolled out. Bedaquiline was moved to Category A drugs. These are drugs used earlier on for better patient outcomes. In seven states, the government has rolled out the new oral regimens, including Bedaquiline. The estimate is they will roll out nationally in the first quarter of 2020.

So, why is the roll-out slow?

Of the 22,000 donations that lie with the government, 7,500 doses have been used. But the pace at which it is being scaled up over the last six months, we expect the government to call us soon for negotiating purchase of more courses. There is no issue with the drug supply, the issue is with capacity building. Currently, less than half of the people with drug-resistant TB in India are not diagnosed, and therefore, are not connected with treatment. We have trained 15,000 doctors in the last four years. We aim to train another 5,000 doctors in the next year.

How many courses would the government look to purchase from Janssen? What price has been negotiated for the purchase?

The Centre would need fresh courses in the first or second quarters of next year. We are discussing terms of fresh procurement as the donation programme has ended. Donation was started globally with this thought of giving time to countries to build resources to introduce the drug, and it has served its purpose. The Centre has floated a tender to procure 30,760 more doses. Now the price negotiation process will start. We are giving a price of $400 (₹28,260) per course (for a treatment of six months) to the Global Drug Facility and 130 countries can access it.

Are you considering price reduction $150 per course is being demanded. Why is a price of $1-2 per day not possible for Bedaquiline, the way it was done for anti-HIV drugs?

$400 per course is a not-for-profit price. We don’t really make any money on this product and all the revenues that we generate go back into capacity building. The way we price our products, I don’t want to be very transparent with you, but we look at the principles of value it offers, access and affordability. Pharmaco-economic studies show that adoption of Bedaquiline will save 60 per cent costs for the government, compared to other drugs that they are currently procuring. Also, regimens of Bedaquiline are shorter, whereas if you look at earlier regimens of TB with injections Kanamycin and Capreomycin they are oto-toxic (rendering a person deaf).

In 2023, the patent on Bedaquiline is set to expire, but the company has filed for ‘ever-greening,’ of patent on Fumarate Salt (a formulation salt of the drug), and oppositions have been filed to these. Will the drug be open to be manufactured by generic companies in light of these patent battles?

Composition of matter patent on Bedaquiline expires in July 2023. So, after that, any generic manufacturer is free to manufacture it. I don’t think there is any issue. Patent application is a standard part of patent filing which happened in 2007. It is a decade-old issue that we filed a patent for Fumarate salts for formulation patent that became public in 2008. It has gone to the patent office and is still under review. There has been a lot of misinformation around patent applications, but the fact remains, come July 2023, generic manufacturers will be able to make their own versions of Bedaquiline.

Still four years remain, (and) affordability is an issue. Former Health Research Secretary Soumya Swaminathan had said voluntary licensing should be done by the company so more companies can produce the drugs at affordable rates. What is your take?

We don’t necessarily see voluntary licensing as a means to drive access. If you look at it today, 22,000 doses have been donated, yet access to the patient is an issue. They are still lying in the government’s shelves and not really reaching the patients. Educating doctors and setting up diagnostic facilities are the real issues. There are not enough microscopes, not enough labs. You may have a drug, but at the end of the day, you need to identify who is sensitive, who is resistant to the drug, and you need to ensure that it goes to the right patient.

What does your Bedaquiline production portfolio look like?

While the active pharmaceutical ingredient (API) is manufactured by Dishman in Ahmedabad, the formulation tablet is manufactured in Receepharm in Bengaluru. We are producing for the world. Globally, 1.6 lakh doses have been disseminated. We have a robust pipeline which is enough to feed current and anticipated demand. Of the 1.6 lakh courses, we have donated around 1.05 lakh courses, and 55,000 courses have been commercially sold to high-burden countries like South Africa, Ukraine, Indonesia and China.

What about lack of ECG machines that’s crucial to measuring the effects of cardio-toxicity that Bedaquiline causes?

We have partnered with non-profits and donated around 500 ECG machines across India in the last two to three years. Lack of ECG machines is a constraint and a resource issue .

What is your total investment for tackling TB?

We have invested $500 million in R&D efforts for TB and HIV. Our fight against TB does not stop with Bedaquiline. At some point in time, there is going to be resistance to this product, and you need to keep developing new products. Science is revealing many new molecular targets to attack to tame this bacteria but the bacteria is smart and we need to stay ahead of the game.

Tell us about your India-related business plans?

Our India footprint is very strong. We work in areas of oncology and immunology. We have launched eight new products over the last five to six years. Our research centre in Mulund is the Asia-Pacific development centre where a lot of scale-up work from Phase 1, and Phase 2 formulations takes place. Our data science team sits in India. In IT and analytics, the world is leaning on Indian talent. Brilliant Indians, who made it big in the US working for MNCs are doing predictive modelling and solving business issues for us. They are feeding a lot of stuff in terms of artificial intelligence and making systems better by helping R&D accelerate drug discovery. We are into business interception. We put a bunch of scientists into how we can prevent a disease from happening by deploying techniques like gene mapping and artificial intelligence. We will actually predict the probability of a person developing a disease, and if there is a way for it to be corrected early.