After Wockhardt received qualified infectious disease product (QIDP) status from the US health regulator, the stock surged almost 6 percent intraday today. Speaking to CNBC-TV18, founder chairman and group CEO Habil F Khorakiwala says it is too early to comment on the market opportunity for the company.
This is the first time QIDP status is given to an Indian company, says Khorakiwala. The two drugs that received the QIDP status include WCK 771 and WCK 2349. The company will take another 2-2.5 years for phase-3 clinical trials, he adds.
The QIDP status will allow fast tracking of the drug application from the USFDA and 5-year extension for the drug patents in the US.
Meanwhile, Khorakiwala shrugs off any possibility of selling stake in the company.
Below is verbatim transcript of the interview:
Q: How much of an opportunity would these two anti-infective drugs be for you and would it be an out-licensing opportunity for you as well?
A: I think these are great things happened to Wockhardt and our Indian research because it is for the first time this kind of QIDP status is given to an Indian company on anti-infective research. These two products are for gram-positive organism and the bacterial organism that you have, 45 percent of them are gram-positive. We have completed phase 2 clinical trial and we are intending to undertake globally phase 3 clinical trials.
One of the advantages of QIDP status is that the requirement for clinical trials is considerably shorter than a normal drug and since it is anti-infective the possibility of getting an approval and completing successful phase 3 clinical trials are extremely high. So, we intend to do it ourselves and then market it ourselves in the United States.
Q: When you say that the requirements for the clinical trial are considerably shorter can you give us a timeline about the way forward, how much time will it take?
A: Generally it will take about 2-2.5 years to complete the phase 3 clinical trial.
Q: How much of an opportunity is it for Wockhardt, these two anti-infective drugs?
A: It is quite early to comment on it. However, total anti-infective market is about USD 50 billion worldwide and out of that gram-positive is about 45 percent of that market.
Q: Are these two drugs, one is an intravenous drug and another is a oral tablet – are they being used in any other market or is it just a freshly developed molecule under R&D?
A: This is entirely a new novel drug. We have a full basis for both these products so it is for the first time in the world it will be introduced.
Q: How much is your R&D spends due to development of these two molecules? Could you give us an absolute amount and maybe a percentage to sales as well?
A: We have been spending on these antibiotics research since last 15 years. So, after 18-19 years we will be having a drug in the market. Now currently we are running about 9-10 percent of our turnover on research and in next few years it will be more or less same or maybe 1-2 percent higher than that.
Q: Any other drug where you could receive a QIDP status?
A: Yes, we are working on a couple of drugs and we hope that because we are only focusing on an unmet requirement of anti-infectonary where FDA is identified because there is antibiotic crisis and that is why FDA has taken such proactive measure to get a drug in the market and incentivise companies to do that.
Q: Could you give us an update on the US FDA issues and where do they stand including the Morton Grove facility?
A: We have undertaken a very significant remedial measure and we should be able to overcome all these US FDA related issues in next few quarters.
Q: There was a company statement given internally that you are in talks to sell out the company but there were some latest reports indicating that maybe you could even be in talks with Lupin. Could you just comment?
A: These are absurd comments coming around by the people in the industry and also media. I have nothing more to say.
Q: Would you be interested in divesting a part of the business if you got a good opportunity?
A: There is absolutely no question whatsoever about it.
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