Moneycontrol
Apr 18, 2017 01:57 PM IST | Source: Moneycontrol.com

Wockhardt antibiotic expected to hit US in FY21, market worth $1.5 bn: Khorakiwala

Wockhardt on Monday said the pay-off of its two-decade old research into antibiotics looks within striking distance, as its drug to treat superbugs is expected to hit the US market somewhere in 2020-21.

Wockhardt antibiotic expected to hit US in FY21, market worth $1.5 bn: Khorakiwala

Viswanath Pilla

Moneycontrol News

Wockhardt on Monday said the pay-off of its two-decade old research into antibiotics looks within striking distance, as its drug to treat superbugs is expected to hit the US market somewhere in 2020-21.

The Mumbai-based drug maker recently announced that it received US FDA approval for the abridged phase-III clinical trial of its drug WCK 5222, requiring fewer patients to test the drug for safety and efficacy, allowing the drug to reach patients much faster.

Along with WCK 5222, four other antibiotic drugs from the Wockhardt stable were earlier conferred breakthrough status to expedite their development in view of unmet medical need to address the rising problem of antimicrobial resistance.

In an interview to Moneycontrol, Habil Khorakiwala, Founder and Chairman of Wockhardt spoke about company’s antibiotic research, plans to rejuvenate its under-performing diabetic portfolio and efforts to resolve compliance issues with the US FDA.

What made you to take up research on antibiotics, an area largely ignored by big pharmaceutical companies?

About 20 years ago we started this programme and it is still continuing despite our ups and downs. The uniqueness of our approach compared to other companies is, we stayed focused on one single area (of antibiotics) over the last many years. We picked an area like antibiotics where we felt that big pharmaceutical companies have left the space for viability reasons. Marketing antibiotics isn’t that complex compared to other drugs. In India, as an emerging market, roughly 25 percent of medicines used are antibiotics.

What is the clinical development pathway for WCK 5222 with the US FDA allowing you to fast-track the trial?

We are planning to start the phase-III trial for WCK 5222 in the next two to three months. It will take about two years to complete the trial and eight months for approval. For our antibiotic, WCK 5222, US FDA has asked us to do a single trial on a limited 650-700 patients. Normally, they ask for two full clinical trials with 1,000-1,200 patients. Now, the fast-tracking allows us to lower the costs and hasten the clinical trial process. We expect to launch the drug in the US in 2020-21.

What is the chance of the drug hitting the market and the potential pay-off?

We have around 80 percent chance of the drug making it to the market. We have commissioned a study and found out that the potential market size of WCK 5222 in US alone is USD 1.5 billion.

Is there any plan to monetize your NCE (new chemical entity) pipeline?

We are considering three of the drugs (WCK 5222, WCK 4282, and WCK 771) for the global development out of five. We will be going to US and other developed countries and get approvals there. Two other drugs (WCK 771 and WCK 2349) - we develop for India and out-license them for rest of the world. We plan to out-license our entire new drug portfolio for the Japan market, where we do not have any presence.

How are you planning to fund the clinical trials and commercialization in the US and Europe?

You are right. Phase-III costs are higher. So obviously this (spend on trials) gets spread over 2-3 years. Since all of these drugs are breakthrough drugs, the relative cost of R&D is modest. We should be able to fund through our internal resources. We have worked out a plan. Also, we have been spending about 12 percent of sales in the last few years on R&D, and that is increasing over the years.

In spite of our modest size on topline – our commitment to R&D is much higher mainly because of drug discovery and clinical costs. (In 2015-16, Wockhardt spent Rs 669 crore or 15 percent of total sales on R&D). Some money will also come from out-licensing. We will start (talks) with external partners for out-licensing NCE pipeline from this year. Commercialization isn’t going to be difficult. We can commercialize on our own, as we don’t need a large sales force for these drugs.

What’s the status of remediation for your plants under US FDA action?

Obviously, we are working on resolving issues raised by US FDA, we have been having regular dialogues with the regulator regarding remedial measures at our plants. We are confident of successful resolution. As part of Plan B, some drugs of the portfolio are being shifted to third-party manufacturers, for both active pharmaceutical ingredients and formulations. (Five manufacturing facilities of Wockhardt are facing compliance issues with the US FDA. The company has earlier said they are taking the help of third-party consultants for remediation).

How do you see FY18? What are the drivers of growth?We can expect double-digit revenue growth. Our India, UK and emerging markets business is doing well and will continue. We are planning to refocus on our diabetic portfolio, especially our insulin pipelines, which wasn't delivering as per our expectations. We want to launch our insulin products in other emerging markets through partners. We are also planning an anti-diabetic portfolio.
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