Dr Sharvil Patel, Managing Director (MD), Zydus group, talks about coronavirus and its impact on business, approval for NASH, speciality segment of Zydus, ANDA's and triggers for FY21 among others during an interview with Swati Khandelwal, Zee Business. 

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Edited Excerpts:

Q: Let's talk about Coronavirus. How serious is it and what impact it will have on your business and update us on your plans to made a drug for it?

A: I would give the history a bit when the epidemic of H1N1 was perceived, we, Zydus, became the first company in India to be able to effectively develop the H1N1 vaccine. So, we are very glad that there was no epidemic but we were well prepared to tackle that epidemic. When we have seen the prevalence and spread of the coronavirus we have also started similar effort to develop an effective vaccine for coronavirus. So, we are working on two strategies (i) With R&D focus in India and (ii) R&D focus in Italy. We are working on two novel approaches to develop an effective vaccine to treat this. It is a very early stage but our efforts are on. We are also looking to see if there are possible drugs that can treat this disease and we are effectively developing those as well. We believe that in the next 3-6 months should have some solution either through a vaccine or through an existing drug to combat this virus.

Q: Can you please provide certain details related to the approvals of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) and your plans to launch the drug-related to it?

A: The Drug Controller General of India (DCGI) has approved the Saroglitazar molecule for the indication Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH). With this, we become the world's first company who has received this approval. NASH is the biggest unmet medical need after oncology across the world including India. When it comes to India then the diseases has 38% prevalence in India. Apart from India, it has a high prevalence in the Middle East, North America and other Atlantic regions. We believe that with this launch of Saroglitaza, Zydus will be able to meet the unmet meet medical need that is needed in India. With this launch, we will like to launch this medicine across the world.  

Q: Can you tell us the kind of revenue contribution that this drug will have in your books?

A: I can't provide any detail about it at present as we are supposed to launch the products. But can provide certain numbers like there are around 50-60 million patients in India who are undiagnosed and untreated due to unavailability of any drug-related to it. If we talk about the disease then NASH starts just after fatty liver, which later turns up to Fibrosis, then Cirrhosis after which the only treatment is liver transplantation. Our drug effectively prevents NASH from growing and prevents disease progression. It also performs other tasks like liver enzyme, lipid metabolism and insulin sanitization, so overall it treats the entire metabolic syndrome. So overall 50-60 million patients are there who doesn't take any medicine and lifestyle modification is used by the doctors for the purpose. Apart from this, globally, two big banks and investors are talking that its, NASH, untraceable market potential stands around 35-45 billion dollars. So, you can say that after Oncology this is the biggest indication and an opportunity for Zydus and we will increase it.

Q: How the speciality segment of Zydus is performing, throw some light on it and prospects of the same?

A: The speciality business is a very critical part of our business and 20%-30% part of our entire portfolio in India is speciality driven and similar efforts are being applied for the US and some of our NCs will drive some of it. We have a lot of programmes in pain management, motor-neuron disorders. We are also working on two Orphan Drug Indication for the US and other markets. We have 6 programmes at present which are in different phases, some in proof of concept and some in PK studies. So, we are building a pipeline for about 4-6 molecules by 2023-24, which will effectively allow us to build our focus on a speciality.

Q: Several companies are facing shortages due to absence of APIs. Let us know about your dependency on China and your inventory in the country and its impact on your business due to APO restrictions by DGFT?

A: No, there is no critical shortage for Zydus portfolio. We have sufficient inventories for both India and the US. These restrictions have been applied and we will study them but it will not have any major impact on us. 

Q: How many pending ANDA's do you have at present?

A: The exact number stands around 130+ but we have received 60+ ANDA approvals in the last two years. And going forward we expect that we will get 60-80 more approvals and that's why we believe that our pipeline is rich enough to continue to get a good number of approvals.

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Q: What are going to be the growth triggers for Zydus in FY21?

A: The base business will continue to grow and do well and new introductions like biologics, vaccines, injectables and speciality business all will add to value creation. We believe that over a period of time, we can create a half a billion of franchises with these new opportunities.