Wockhardt, which recently completed phase 3 clinical trials of Nafithromycin, a drug developed by the company to treat community-acquired bacterial pneumonia, expects a manifold jump in revenue with the commercial launch of the product. The results of the study showed that a three-day treatment with Nafithromycin is as effective as seven-day therapy with Moxifloxcain.
Wockhardt reported Rs 2,773 crore in total revenue in FY23. It plans to transform into a R&D focussed company and launch more patented drugs. Founded in 1967, Wockhardt recently attracted investor attention, with its stock doubling in the past three months.
In an interview with Moneycontrol, Dr Habil Khorakiwala, Chairman of Wockhardt, talked about the pipeline of drugs and the company’s plans. Edited excerpts:
When can we see the commercialisation of Nafithromycin in India?
We have completed phase 3 clinical trials and we are ready in the next few weeks to make our formal application to the drug controller, sometime in February. We hope that after three to five months, once we get it cleared, the product will be in the market. You can say in the second half of this year we would be in the market with the product with full approval.
What about other markets?
In the global market, we will be completing our phase 3 clinical trials sometime during the year 2024. We have completed phase 1 and phase 2 in the US and Europe and phase 3 was done in India. After another 8-9 months, we would be simultaneously filing once we get the approval in other markets. We should be filing in early 2025 globally in the emerging markets.
When can we expect commercialisation and topline effects of products under development?
We do expect that over the next few years, it will be a very significant product. In general, we expect business in hundreds of crores only in India, and emerging markets will be on top of that, which will start coming in the next few years.
We have novel products in the pipeline like WCK 6777 (globally only once-a-day, multi-drug resistant Gram negative antibiotic for out-patient intravenous therapy) and WCK 5222 (a novel class of drug to treat extreme pan-drug resistant life-threatening infections such as hospital-acquired/ventilator-associated pneumonia (HABP/VABP). Every two-three years, one would see a new molecule coming out of our discovery programme. We intend to consider licensing out WCK 5222 to big pharma company and that is where we will get a significant amount of pay and then that will continue that process.
What are your R&D investment plans and how will they pan out?
We have been investing on an average about 12 percent of revenue in R&D. Initially, it was for pharma, technology-related areas, and, to some extent, for biotech. But now, the ratio is nearly 90 percent for drug discovery and biological new drugs. We would be more of a research company five years down the line.
How confident are you about your drug discovery journey?
The programme of our antibiotic research started about 25 years back and we went for antibiotics because we believed at that time that big pharma companies were vacating that space and therefore our research programme would be very competitive. There are a lot of other companies who started programmes very aggressively but today none of them are there because they could not sustain it.
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With our research, we have developed Nafithromycin with a lung exposure eight times higher than Azithromycin and potency being 10-100 times higher for some respiratory pathogens. Phase 3 studies have also shown that three-day treatment with Nafithromycin is as effective as the other options we have today. It has nearly 97 percent success, which we saw in this clinical trial. Additionally, it is an oral treatment, which will be enormously cost-effective.
What are your plans to reduce debt?
Our external debt is only Rs 1,000 crore today. It's not that significant. We are trying to make it (the company) a little stronger in terms of our liquidity. We are restructuring our organisation financially. So that would include all possibilities of restructuring the debt for the future and also injecting some equity too.
What about plans for biologics?
In the biologics space (drugs made from living organisms or containing components of living organisms), we will focus on emerging markets. We believe the newer drugs which are coming in - insulin and other glutides - some of them which are anti-diabetic have now become for weight reduction. So the whole potential of that market is very, very significant. And many of these product patents expire at the end of the year.
So, in the next two to three years, we see potential in the emerging markets. In the Western market, patents are there for another five to 10 years. This is a great opportunity available to us to build up a portfolio in that space.
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