Launching products in India at the same time as FDA approvals: Bayer

Headquartered in Leverkusen, Germany, Bayer is one of the oldest healthcare companies in the world with over 150-year history and focussed on three verticals - pharmaceuticals, consumer health and crop science. The group has 354 companies in 83 countries and with revenues of 50.7 billion euros in 2022. Bayer has been in India for more than 125 years.

In an interaction with Fortune India, members of the executive committee of Bayer Pharmaceuticals - Anne Grethe Mortensen (Chief Marketing Officer and Executive Vice President) and Julio Triana (Head of Commercial Operations, Japan & APAC for Pharma, President and Representative Director, Bayer Holding Ltd) talked about new product launches and operations in India.  

Bayer has been in India for more than 125 years and has a fairly known presence in crop science particularly. The pharmaceutical vertical also has a great presence, but when compared to other MNCs it may not be that sizeable. In the case of pharmaceuticals – given that Bayer’s India connection started over a century ago – how do assess your capabilities with respect to fairing in initiatives like Make in India or Making for the World from India?

Julio: I agree with you that we are under-indexed in our pharmaceutical business, and that is why our strategy is changing. We have been in the market for more than 125 years, and in addition to the crop science business, we also had an extremely strong presence in the chemicals business, which eventually split up into different companies like Lanxess, which is one of our offspring. That company continues to thrive here. We also have Covestro, which also has a good operation here as well. In terms of our pharma business, we started our partnership with Zydus over a decade ago, as we felt that we needed the guidance of a local company that had the expertise and would instill confidence in us while helping us navigate the regulatory landscape. That is something that’s really good, those regulations and policies have evolved. We have also changed our strategy; we are a company who have always brought innovative products to the market. More and more, we are focusing on innovation and we want to bring our medicines to countries that value this kind of innovation and have a population where our portfolio can fit in really well. We have decided to focus on therapy areas like Oncology and continue to be a powerhouse in Cardiovascular – which fits very nicely with India’s population. While we are not happy with the size, as part of our strategy we are doing everything possible to make it as big as possible. We now have the portfolio, we believe the environment is set for us to thrive, and the Indian government is valuing the innovation that we can bring to this market. It is well received here, and we have a lot of patients to treat here and deliver our medicines to.

Anne: With the three recent launches – we are launching products almost at the same time as FDA approvals, whereas in the past we have waited 3-4 years. With the Verquvo, Kerendia, and Nubeqa launches – we are seeing a much more rapid and dominant position of the Indian team. Particularly for Nubeqa, India is the second-biggest recruiting country in our lifecycle programme. In the forthcoming years, we will have a bold position in India. Across the board in healthcare, more than 60% of our portfolio is manufactured in India through different strategic partnerships. We are also sourcing a lot of materials out of India which are being utilized for our manufacturing units in Europe, Latin America, and elsewhere – for around 50-60 million euros which is being outsourced. This could be for APIs, key starting materials, etc. In the sense of the Bayer world, we have a very deep-rooted presence even in the pharma space. we have a global strategic partnership with Divi’s Laboratories which is one of the biggest API manufacturing facilities in the world. Our partnerships for our contrast media agents are Ultravist, for which they are our global supplier. We have similar partnerships with other organizations as well. We have in India four patented products and blockbuster drugs like – Xarelto, Eylea, and Mirena are the backbone of our current business here.

Which are the new products that are coming to the Indian market?

Anne: If you look at the company in general, our biggest upcoming launch is actually a replacement for Xarelto. It is ‘Factor XI’ which is a huge initiative, and we are also recruiting patients from India. It is also our belief – which we have mentioned to the financial market – that this will be a +5 billion compound. We intend on bringing it to the Indian population as soon as possible, and that means it would be at the same time we are launching it in the rest of the world.

Julio: I also want to capture some of our recent launches. Verquvo, launched 7 months ago, is our drug for worsening heart failure. There are about 8-10 million people in India suffering from heart failure. Usually, Indian patients get this earlier than those in other parts of the world, particularly those between 50-60 years old. Indians are developing worsening heart failure; about one in six of them develop the disease. We launched this product seven months ago and we are very excited to see what this can do for the population out here in India. Our other drug, Kerendia, is our product for chronic kidney disease. There is a large population here in India of people with diabetes – around 75 million or so. India is the second largest country in the world with an incidence of diabetes – after China. More than 30 million people have chronic kidney disease.

Anne: I had the pleasure of being in the Indian market, and the professor so nicely said that this is the way to preserve the kidney because India has a significant investment currently in dialysis, and it can pose a huge challenge as there is simply not enough capacity to maintain the services owing to the amount of services. I am happy to say that this is going to have a strong position in heart failure, this is a huge problem in India as well. India is involved in our life cycle programme, which is to expand from CKD to heart failure.

Out of the 30+ new products in Bayer’s drug pipeline, 9 are already in phase 3 trials globally. How do you plan to have these trials done in India as well? Going forward how will India be a part of your R&D plan?

Julio: We recently opened our Centre of Excellence of R&D in Hyderabad. It has around more than 100 people currently, which will continue to increase. The idea is that the group would support our global clinical trials and anything that has to deal with data science and analytics. Additionally, we are also making sure that our global trials are more representative of Indian patients, and ensure they are being studied. This is key to ensure that as soon as we have approvals for these medications, we will be able to bring these medications to the Indian market. For some of our recent products, we were able to make them available in the Indian market. As mentioned earlier, we were able to make the product available in India before we were able to make it available in places like Germany, or other parts of Europe. This is a huge benefit to the Indian patients, as usually, these markets have to wait for at least 3-5 years to get these innovative products, unlike now where we are trying to make it accessible as soon as possible. This is significant, what we believe, if you want to call it a competitive advantage but will benefit the patients by bringing these innovative products as quickly as possible to the market.

India has great availability of qualified manpower. How do you plan to leverage that as part of your global R&D and manufacturing operations?

Julio: Yes, this is the reason why we started the Center of Excellence in India, and not anywhere else. There are extremely talented people in India. While APIs and manufacturing are important, we want to focus on creating more high-value-added jobs, and this country has a lot to offer in this regard, like data science and analytics for example. There are plenty of data scientists here and we hope to recruit and hire more people who are scientifically driven. India has a lot of physicians and good universities. We also wish to scout some early science as well from top universities and be able to bring it into our pipeline. The local team here will help us with all these endeavors so that we do not miss out on any opportunity.  We are rapidly scaling up our Excellence Center in Hyderabad, which is essentially a part of our global R&D team. We also have a large global business service in Bangalore, which employs close to 1000 people now – supporting several platform functions across the globe. In addition, we have organizations like TCS and Accenture, who partner with us on some critical pharma topics.

Talking about the global scenario, the entire healthcare landscape has altered post Covid-19. How does Bayer view this change?

Anne: We have a very strong focus on therapy areas like Cardiology and Oncology. Additionally, we are evolving Nubeqa, especially with the increased recruitment in India. We are also evolving into Asundexian. However, we are also making huge investments in the Cell & Gene therapy area, for which we also acquired several companies, and are also engaging in several partnerships around our research center in Boston. Through these efforts, we are spreading ourselves more than before. We are also looking into neurology and rare diseases at this centre.

Julio: We recently opened a site in Kendall Square, Cambridge Massachusetts – and is one of the meccas around the world in terms of biotechnology. We are running part of our oncology research from there. We have a strong collaboration with the Broad Institute, this is an institute which is a joint exercise between MIT & Harvard University. At this site, we are housing one of our newly acquired companies called Blue Rock – in the area of Cell Therapy. We have several interesting and promising programmes in this regard, a programme for Phase 1 trials in patients with Parkinson’s disease. Additionally, on the East Coast, we acquired another company specializing in Gene Therapy called Asklepios BioPharmaceutical (AskBio). Lastly, we also acquired Vividion Therapeutics based on the West Coast in San Diego. We hope they will be able to help us identify what we call undruggable targets with precision therapeutics in the Oncology field. We are making significant investments in the area of biology and have come a long way from how we started 125 years ago as a chemicals business and that’s where our pharmaceuticals business originated. We believe this is the century of Biology, and that there is a convergence between Biology and Computational Science – and we want to leverage that; that’s where we are putting a lot of our investments. All these companies are independent in nature, which gives us a competitive advantage to be able to identify breakthrough science and interesting technologies that we want to bring into our pipeline of fighting diseases and be able to keep them at arm’s length. These are companies that continue to run themselves in the way they worked before we acquired them, they still have their own management teams. We are a part of their boards that we let them operate independently. We offer them a platform that a big pharmaceutical company like ours is able to provide those services to help build and innovate such products. Once these products are ready to go to the market, we will use our extensive presence around the world to bring these to as many patients as possible.

Anne: We are putting a lot of focus into early research. There is a misconception that Bayer is not interested in Women’s Health anymore. While we are not focusing on early research in this area, we are still developing products in Women’s Health. We are the world leader and we have a big launch coming up in 2025 for a product called Elinzanetant that is for vasomotor symptoms in menopause. This shows that we are very committed to Women’s Health just not in early research.

You talked about how science itself is changing in terms of innovation – like gene therapy, cell therapy, or even Biologics taking a front seat in innovation. Simultaneously, data analytics and AI are playing a huge role in changing the world. How will this impact a life sciences company like Bayer?

Julio: This will change the way we do things big time. Right now, we have a lot of hypotheses, but we are also already seeing a lot of first ways in which we can do this. One of our strategies is to examine how to leverage this across our entire value chain. We are starting with early research, followed by innovation where we are applying a lot of Artificial Intelligence & Machine Learning techniques, that our Excellence Center in Hyderabad is involved in. This would help us identify targets much quicker, and hopefully save time and effort, due to these technologies. As we move up the value chain, we are also implementing virtual reality (VR) in our manufacturing facilities. We recently also won a prize for our advanced facility in Garbagnate, Italy – which is fully automated and digitalized. Here, you are able to take a look at the machines and will be able to see all the information through the VR glasses. This will tell you when the machine was last maintained, the number of pills we are producing and so on; to also reduce the number of times it takes us to produce. We are also leveraging digital and AI in the way we go to the market as well. We are trying to apply data science and AI across everything we do. Our key learning from the pandemic is that collaborations with different companies (like different organizations, and governments) enable us to deal with the impossible. Our arm’s length concept (letting our acquisitions remain independent in their functioning) stems from this learning itself. For example, you bring a vaccine from nothing until you have it out and being able to inject it into humans in 18 months. This was short of a miracle that we did as an industry. We wish to reduce the time by half that it takes us in the entire drug life cycle – from discovery till we have the molecule into a patient. Today it takes us an average 10-12 years to be able to do that, as we start with 10,000 hits and only one makes it, and we spend around 2-2.5 billion. Imagine if we were able to do that in a fraction of the time; if we are able to have that, the impact that we would have on society would be larger. We are trying to ascertain how we can leverage computational science to achieve that and benefit society at large. Anne can elaborate on the commercial part.

Anne: On the go-to-market model, we are using artificial intelligence. We are able to do segmentation in a completely different manner than we did a couple of years back. Now we can go into micro-segmentation. We can make sure we are addressing the topics that are of relevance to the individual physicians we are seeing. Unlike the older times when we did a campaign every half year, we now directly address what is on top of mind for individual physicians. We are implementing suggested engines to achieve the next big action instead of just doing what they’ve always been doing.

Bayer is heavily investing in cell therapies and future technologies. However, being 125 years into pharmaceutical science and in this evolution do you think you have missed investments in the Biotech portfolio in the past two decades? When a similar pandemic disrupts the world, how prepared should we be, and what are Bayer’s contributions to the same? Also, why are vaccines not part of your portfolio?

Julio: We haven’t missed that boat. As I’ve said, our strength is the chemical part. This is something we continue to be very proud of. It is not like chemistry will not be used to find targets. It will continue to be used; it will continue to be relevant. There are many diseases out there that we still haven’t been able to figure out. For instance, if you look at what Vividion does, they do extremely well as they are using chemistry to solve issues. We contend with competitors if ours is the largest or second largest library of compounds in the world, and we still have that, and we are leveraging that. We will continue to nurture that as it is a key capability of ours. If you see where the science is going, we are always following the science; it is shifting more towards biologically driven solutions. This is why we are making these investments.  Investments really need to take place now, or else we really do miss the boat. That is the reason why we’re allocating capital to make sure that we do that. We are in an industry that has a very long cycle. We are making decisions today for problems that might be in the market in ten years’ time. We hope that we can reduce the time in the drug cycle. We will continue with the medications in our pipeline; whatever you can see is published, the majority of it right now is chemicals and some biologics. More is going to shift to have a different mix, where we have more biologics. We’re not doing this knee jerk reaction and where it’s going entirely into biologics because we still are a powerhouse in the chemicals space.

In the next 5 years, where do you see India contributing to Bayer’s global revenues? How key will be India in the global scheme of things in the next 10 years?

Julio: In my previous job I was the CFO of the company in the division. I started out in this industry in the laboratory. I do not like to see the potential of the market by the top line or the sales it generates. I would like to see our potential in India in the sheer number of patients we will be able to impact through the medications we are going to bring. That would be an adequate measure of our success. One can look at India in terms of the number of patients on the two products launched recently – Kerendia and Verquvo and India shows up in the top three of the products in the world. This is unprecedented as that was not the case in the past. I measure our success in being able to bring medications that are innovative, that we can give to as many Indian patients as possible and that would be in millions.

Anne: We wish to reach millions of Indians as possible who are on dialysis.

Can you put a number to your planned investments in India in the next 5 years?

Julio: We are investing disproportionately and is contingent on how many patients we can get into our medications.  We will invest accordingly for improving medical education and accessibility of our products. It is difficult to give you a number. What is important however is that we continue to get to as many patients as possible in the therapy areas of Oncology, Cardiovascular, and Women’s Health. These areas are a good fit with the ailments of the Indian population, so we are hopeful that our products will reach hundreds of millions of patients. We are committed to putting all our resources in finding those patients, and we help Indian physicians to identify those patients and we are not going to take any shortcuts. It is a significant opportunity.