Mumbai: Drugmaker Wockhardt Ltd’s extensive antibiotics research is expected to start yielding benefits soon, with one of its new drugs likely to be launched in the US in 2020-21. Notwithstanding regulatory issues, the company’s new drugs pipeline of five antibiotics looks promising, says Habil Khorakiwala, founder chairman of Wockhardt. In an interview, he talks about how the new drugs portfolio will pan out and ongoing efforts to resolve compliance issues with the US Food and Drug Administration (FDA). Edited excerpts:
Wockhardt recently got USFDA approval for the abridged phase-III clinical trial for one new antibiotic. When will the company start the trial and when can we expect the product to be launched?
We will start trials for WCK 5222 in two to three months. It will take about two years to complete the trial. Today, there is a major crisis in antibiotics. It has happened mainly because large companies have reduced or given up antibiotic research over the last 30 years and the number of approvals has come down. We started our antibiotics research programme 20 years back. In all, 11 antibiotics in clinical trials have received qualified infectious disease product (QIDP) status, of which five are Wockhardt’s drugs. One of the things that the USFDA has done is that where there is a huge unmet need, they are fast-tracking approvals. For our antibiotic, WCK 5222, USFDA has asked us to do a single trial on a limited 600-650 patients. Normally, they ask for two full clinical trials with 1,000-1,200 patients. Hopefully, we will launch the drug in the US in 2020-21. We might have to do some trials post the marketing approval.
In what stage of development are the other four new antibiotics?
For two drugs—WCK 771 and WCK 2349—we plan to soon begin phase-III clinical trials in India and hope to launch them in the domestic market in two years. Another one will enter phase-III trials in India after about eight to nine months. The next new drug that we plan to take to the US market is WCK 4282, which is indicated for treating urinary tract infections, hospital-acquired bacterial pneumonia and bloodstream infections.
Will you out-license the new drugs?
We are not looking to out-license all of them. Some of the products for hospital-acquired infections (the company has three such products) we can commercialize on our own. For those drugs, we don’t need a large sales force. We may look at partnerships for other drugs for the US market. We plan to out-license our entire new drug portfolio for the Japan market, where we do not have any presence. For Europe and other markets, we haven’t decided yet.
How are you funding the research activities?
We have about Rs2,000 crore of cash; so we are utilizing that. Plus, with our growth in India, the UK and emerging markets, we expect profitability to improve. This will be able to absorb our research and development expenses. We will maintain R&D spend around the same level as last year or slightly higher for the next two years and a significant portion of it will be spent on clinical trials of new drugs. In 2015-16, R&D spend was Rs669 crore, accounting for 15% of total sales.
Wockhardt’s five manufacturing plants are facing compliance issues with the USFDA. What remedial measures has the company taken?
We have been having regular dialogues with FDA regarding remedial measures at our plants. We meet them two to three times a year. Some of the things we have done are that we have a whole new team in manufacturing and quality control and we are giving a lot of training to employees at various levels. We have automated quality systems to ensure data integrity. We are also trying to simplify operating procedures. All these activities are being done along with third-party consultants. We are focusing on one plant at a time.
Were any of the company’s plants inspected recently by the USFDA or is any inspection likely in the near future?
I will not be able to comment on this.
Given that US business has taken a hit due to regulatory issues, what is the growth outlook for the next two-three years?
We can expect double-digit revenue growth. Our India, UK and emerging markets business is doing well and it will continue. For the US market, we have already initiated a process of site transfer for critical products to third-party manufacturing plants. This is for both APIs (active pharmaceutical ingredients) and formulations. So, we are trying to mitigate the risks. We might get some product approvals in the current year and also in the next two years. We also hope to get clearance from USFDA for our plants. Any positives in terms of US market will provide incremental growth.
What about profitability?
I would not like to comment on this.
Are you planning to launch insulin products in regulated markets?
We have already launched insulin products in India and in emerging markets. In the near term, we are not looking to launch them in regulated markets as our focus is on the new antibiotic drugs pipeline. However, diabetes is one area where we are trying to build a portfolio for the US market.