DR. SHARVIL PATEL, MANAGING DIRECTOR,

ZYDUS CADILA

"As we transition from a pure generics company to a branded generics company, we believe access and affordability will continue to play a key role in our growth story."

How is Zydus Cadila’s business positioned for the coming decade?

We see four pillars of growth. First, the business will be strongly driven by drug discovery and innovation. Second, patient centricity will be an important area in terms of how we design our programs for outcomes. Third, we intend to hone in our efforts to digitalize our capabilities both in the front and back end to be able to reach more customers in a better fashion. Also, COVID taught us that having a strong diversified infrastructure aids in overcoming challenges.

As we transition from a pure generics company to a branded generics company, we believe access and affordability will continue to play a key role in our growth story. However, drug discovery and innovation will drive the future growth for the organization. These innovations will be outcome driven. We will work across areas like vaccines, biologics, small molecule research, and transdermal injectables. This strategy will be modeled off of our success in generics, where we have 400 plus ANDAs in the US.

We will also have a large pipeline of products that meet the access and affordability criteria. A large part of substitution happens today in the US once the patents expire, and we will build onto that. Meanwhile our strategy in India, is to be more therapy specific. We intend to launch new therapies in the areas of Non Alcoholic Steatohepatitis (NASH), Oncology, Renal Care, and Autoimmune diseases.

As the 4th largest pharma company in the US, how has Zydus Cadila adapted to meet customer needs?

The generics market in the US has been a mainstay for Zydus Cadila’s business and it has transformed substantially in the last couple of decades. Our main strategy in the US is to make sure we have an efficient cost of goods supply chain which can meet the demands of the US market. We are looking at how to backward integrate in order to de-risk our supply chain and make sure that we are able to continuously supply good quality and quantity drugs in the US. R&D must be productive, and we believe we should be filing 30 to 35 new drug applications (NDAs) every year in the US from a generics point of view. Today, we are largely an oral solids company, but we are transitioning towards more complex products like transdermals. A large part of our portfolio in the future will be driven by complex injectables.

Zydus is developing a novel vaccine in ZyCoV-D. How did you choose this platform and did you have the in-house capabilities to develop this?

Zydus has more than 300 scientists who work on vaccine research, so it is an area we have great expertise in. We were the first Indian company, and the third in the world to develop and commercialize the Swine Flu vaccine in 2010, and we have worked to develop several other vaccines.

Over the past year, we developed a vaccine for COVID-19, which is based on a DNA platform. It is currently in phase three clinical trials and is being tested on around 30,000 volunteers. In the Adaptive Phase I/II trials we received strong safety and immunogenicity data. In the Phase III trials we will ascertain the efficacy of the vaccine. Once launched, ZyCoV-D will reinforce this fight against COVID both in India and other countries in need of vaccines.

What are the advantages of the DNA platform used in ZyCoV-D?

One of the reasons we chose this platform is we believe that when the body of evidence is low, safety will be one of the important markers for selection of a vaccine. We saw very strong safety markers when it came to this technology on DNA. A second factor was that it is much simpler to manufacture because it has minimum biosafety requirements. Therefore, one can easily find facilities. Also, a lot of vaccines are vectors which elicit immune response. Our vaccine is devoid of any vectors that are present in the plasmid.

Further advantages include the fact that as mutations occur, this platform enables us to change the sequence of the virus very quickly. Finally, there is vaccine hesitancy when it comes to taking injections, but ours is an intradermal device and not an injection. It is a small application on the skin, devoid of any major side effects and it is painless to administer.