Ahmedabad-based Zydus Lifesciences has recently forayed into medical devices and companion diagnostics. In a virtual interaction with Sohini Das, Zydus MD Sharvil Patel says medicines are only a part of the solution. Edited excerpts:
You have recently forayed into med-devices. What is your game plan?
When we looked at our next 10–15 years’ strategy, we changed our name from a pharmaceutical company to a life-sciences organisation. We would like to play a larger role beyond pharmaceuticals alone, where we can offer better value to patients in a more holistic manner. Medical devices, companion diagnostics, early diagnostics — these are areas we are looking at.
We decided to enter three important areas right now — interventional cardiology, nephrology and orthopaedics. We have acquired a manufacturing footprint in India for interventional cardiology (stents), and we have partnered with a Brazilian company, Braile Biomedica. Braile is one of the few companies that have a Transcatheter Aortic Valve Implantation (TAVI) product, which is a minimally invasive procedure for replacing diseased aortic valves. We are looking to build up our franchise in interventional cardiology within India and globally.
In nephrology, we are building a facility to make dialysers — one of the few, if not the only, facilities to do so in India. We want to create capacity for the chronic kidney disease space. In orthopaedics, we have acquired Amplitude Surgical, which makes knee implants.
In diagnostics, we have partnered with Guardant Health for liquid and tissue biopsy tests. We are looking at what kind of products, diagnostics or other solutions we can offer to become a well-rounded player in a particular disease area globally. Medicines are some part of a solution, but not the full solution.
From Day 1, we have had a global ambition in the med-devices space. India will obviously be important, but we are looking at having a global footprint.
What kind of revenue contributions are expected from this division?
It is a bit early to talk about revenue contributions as we have not yet closed the Amplitude deal. Some of the largest medical devices companies are around ₹1,000 crore or so. We want to see how fast we can scale to the first ₹1,000 crore, and that's our immediate goal. This division is a 100 per cent subsidiary of Zydus Lifesciences, and at the moment there are no plans to raise any funds.
Another area you are focusing on is rare diseases. Tell us about your plans.
We are clear that we will work for unmet medical needs. We are targeting areas where there is significant unmet need in terms of disease burden. Volume-wise, these are not large opportunities (seven to 12 patients a year at times), but I think it creates a differentiation both for the organisation and the market. Wherever we can create an impact, we can create value.
The US has a well-established model in terms of working on these areas. We have three drugs today — two approved and one under approval. In India, we have MMV253 (an antimalarial drug candidate which has received orphan drug designation from the USFDA), and also the rabies monoclonal antibody (mAb) TwinRab, which fall in this area. Slowly, we are adding more pipeline drugs from within Zydus and also through partnerships. We have started adding Europe, the Middle East and other countries.
We are also working on orphan diseases where patients have limited access to medicines and treatment. We are working on Saroglitazar for the treatment of primary biliary cholangitis (PBC), a drug that has been granted orphan drug designation by both the USFDA and EMA. Additionally, we are developing Usnoflast (ZYIL1) for patients with Amyotrophic Lateral Sclerosis (ALS). Orphan diseases are rare and life-threatening conditions affecting a limited number of people.
Given the global uncertainties, do you think a global manufacturing footprint will be a future trend?
While distributed manufacturing is going to be a reality, I believe that a large part of manufacturing will be in India because the first principle is to make affordable medicines. India offers the most cost-competitive capability for manufacturing. It will make tactical sense to have some manufacturing outside depending on the opportunity and capability. This will be more specific company-wise, based on their strategies, portfolios and target markets. India will remain the fulcrum of manufacturing.
We work with partners who have manufacturing in different countries where we can block capacities for our products. For example, in Myanmar, we have our own facility because that country requires local manufacturing. Countries like Vietnam require us to transfer our technology and products and we jointly manufacture. In Brazil, we have our own operations.
As the leading biosimilars player in India, what’s next?
Our major focus areas are oncology and autoimmune segments in the biologics space. A large portion of the products are in the area of immunology.
We have a large pipeline of 12–14 products in different stages of development and have already commercialised 14 products. We want to be first in India, and then enter other international markets with our biosimilars. Latin America is a very important cluster for us, apart from the Middle East and North Africa region, while South Asia is another important cluster. We are also evaluating developed markets like the EU.
Which vaccine candidates are you bullish on?
For vaccines, we work very strongly in the private market. We have the flu vaccine, which is doing extremely well, and we are one of the largest players in India in both child and adult flu vaccination. We see an opportunity for our new typhoid conjugate vaccine (bivalent typhoid and paratyphoid conjugate), apart from the Hepatitis E vaccine and Chikungunya vaccines under development. Post the Covid-19 pandemic, adult vaccination is doing well. We see good uptick there.