‘Olumiant is already present in 50 countries around the world with more than 22,000 patients on it’

Eli Lilly and Company (India) recently announced the launch of Olumiant (baricitinib), marking the company’s entry into the autoimmune segment in India. Luca Visini, Managing Director, Eli Lilly and Company India, divulges more details about the once-daily oral medication for adult patients with moderate-to-severe active rheumatoid arthritis, it ability to provide relief to those who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), his company’s plans for this segment, its larger vision for the Indian market and more, in an exclusive tete-a-tete with Lakshmipriya Nair

You have announced the company’s entry into the autoimmune segment in India? Tell us more about it.

It is a very exciting moment, part of that is also luck. This year we’re celebrating 25 years of Lilly’s presence in India. So, it’s a very symbolic time, marking a quarter-century. Today we’re specifically talking about one of those innovations that have characterised Lilly’s presence in India, and we’re talking about the autoimmune space.  This, for us, is an important news because it’s the first time that we are entering the autoimmune space for Eli Lilly and Company and we are talking about this at an auspicious time. Just a couple of days before the World Arthritis Day when we’re bringing in the market a therapy for rheumatoid arthritis.

Can you give us an overview on the problem posed by rheumatoid arthritis and the challenges in its management?

Talking about numbers, four to five million people in India are said to be suffering from rheumatoid arthritis.  Women are three times more likely to develop rheumatoid arthritis than men and the age during which they are likely to develop rheumatoid arthritis is around 30 to 50 years.  It’s a bit early in the lifecycle, and part of the challenge is that around 50 per cent of the people who have been treated with conventional drugs do not achieve remission, they do not feel better, or they feel better in the beginning and then they go back.

It’s not only about the mobility or the stiffnesses; it’s also the pain that comes with it, like holding a pen, getting a cup of coffee or participating in social events.  Thus, in rheumatoid arthritis, despite multiple options already in the market, multiple types of therapies, their problems are still huge.

Unfortunately, current treatments are still leaving a lot of unmet needs. So, that’s why we think that bringing a new therapy, oral, once a day that can help the doctor effectively prescribe for those patients who are not responding well to the current treatment. Now, we have a solution for those patients who are not any longer responding well to the conventional drugs. The solution is now getting to India. It is present in other countries around the world.

Can you tell us more about the drug you are launching in this space?

Olumiant, our first in the autoimmune space is a once-daily oral treatment indicated for moderate-to-severe rheumatoid arthritis, as indicated in adults and patients that either respond inadequately to the current treatment or are intolerant to the conventional treatment. So basically, they need some more help. Talking about numbers, four to five million people in India are said to be suffering from rheumatoid arthritis.  Women are three times more likely to develop rheumatoid arthritis than men and the age during which they are likely to develop rheumatoid arthritis is around 30 to 50 years.  It’s a bit early in the life-cycle, and part of the challenge is that around 50 per cent of the people who have been treated with conventional drugs do not achieve remission, they do not feel better, or they feel better in the beginning and then they go back.

Now, we’ve Olumiant. The clinical trials for this drug have been done in 37 countries with 3500 patients. India was included as well in the trials.  They are proving that as a wrap-it-up set, as early as within week one, they start benefiting in a significant way on what we call patient-related outcomes through symptoms that are generally pain, fatigue and morning stiffness. The benefits are due to a once-daily oral pill.  Olumiant is already present in 50 countries around the world with more than 22,000 patients on it. So, it’s also very fairly used outside.

Why wasn’t it launched earlier in India or why is this the right time to launch it?

I like the question ‘Why is this the right time’. To me the right time is because we can. So, responding to your question, we develop drugs generally on global clinical status. The moment we have those global clinical status we start the regulatory process in different countries in the world and according to the regulatory process, how things are structured, we make it available. So, for India, last year we got the approval. The next steps, at the end of the year, regulatory-wise that we needed to go for, allowed us to launch it now.  That’s why today and not last year or before.

So, how does this drug shorten the time of treatment or improve it?

Very good question.  RA is chronic. It’s autoimmune. When it starts, it’s chronic and what it does by the time you continue with it or it is not controlled is that it will inflame the joints, it will damage the joints and the risk is that its restricting mobility and inducing disability. What Olumiant does is after the first line of treatment that is conventional, when they’re not working any more. It will help in working quickly on the symptoms, pain, the fatigue, the stiffness and it will help slowing down the damage that rheumatoid arthritis is bringing into the joint. So basically, it will preserve the condition longer before it gets worse and worse. And today after the conventional, there are generally injectables that you go through. In this case, what works for patient compliance is that this is an oral drug.  It is a once-daily oral drug. So, it will help the patient be more compliant to treatment.

Is there a way to find out whether we’re genetically predisposed or geographically or racially predisposed to the disease?

So, we know that there are factors that play into the likelihood of having it and genetics is one of that besides some behavioural factors. Smoking and lifestyle behaviour are a part of it, but there is no definitive way to say yes someone will develop the disease, someone will not develop the disease. So, that is there and how we are styled. The more we know about the human body, generally speaking, not talking about rheumatoid arthritis or autoimmune disease, the more we know what are the components that might be prone to develop it, the better, but we do not have a way to know if we will develop it.

How is this launch a part of your larger vision for this market?

India is clearly a country where we have a lot of interest, not only because we work here and this is basically our job, but in terms of our overall long-term strategy, when we talk about Lilly worldwide. When we talk about therapeutic areas where we are in, some of them are traditionally where Lilly has been, like diabetes and oncology, and there is the autoimmune space. Today is really the day we premier in the autoimmune and pain segments.  So, what you can expect and what we all can expect is that for the years to come, in the world and across India, these four pillars, these therapeutic areas are where we’ll be launching drugs. So, our pipeline is mainly in these therapeutic areas.

I think earlier this year you had a tie up with Lupin for diabetes. Are you planning some kind of a tie-up for this space as well?

We did. It is correct. We’re in alliance with Lupin. We were already in alliance with Lupin with two products this year. Even recently, in this month, Lupin announced a launch with us in diabetes.

Well, when it comes to rheumatoid arthritis and when it comes to Olumiant, one other question we ask ourselves is can we launch on our own? Can we make available a drug for the Indian patient alone in an outstanding way and can we do that alone? If the answer is yes, then we go alone into the market and in this case, the answer has been yes. We can handle that directly and that’s why we’re handling it in-house.

India is also a very cost-sensitive market. How affordable is this treatment — this drug?

So, India is a price-sensitive market and we cannot avoid paying attention to that, so what we are doing is, we are launching the product and with Olumiant, there will be a patient-support programme to help patients who are struggling with access to the drug in terms of affordability. The patient-support programme will help with this.

In comparison with other global markets, what are the unique characteristics of the Indian market?

That’s an interesting question because it is just part of my learning trajectory in the country.  When we think about India clearly the size is impressive, because there is no other country apart from China that has this size. Now, with the size of the country also the size of the unmet needs is there. So, for Lilly, clearly our mission is that we make drugs to improve patient lives. Where there are unmet needs in therapeutic areas our goal is to make sure that we tackle that. Now, having said that, according to the type of country, according to the type of healthcare system, there are challenges that arrive. In case of India for instance, India being an out-of-pocket country — as you said price is very sensitive. So, our focus is, how do we make sure that affordability is there. Geography wise, you have countries like Switzerland that is basically a neighbourhood of Delhi or Mumbai literally in terms of people.  So, here the challenge is that how do we make sure that we’re able to reach the doctors that are around India with our education, with our messages.

Regulatory wise, every country has its own focuses.  Our goal here is to make sure that we understand what the requests are and we’re ready to comply with those requests.  You’re asking me the question today.  Well, everywhere in the world what we do is work around the timelines to make the drugs available according to the local laws.  India is not any different.  Our attention is on making sure we know the process and we keep ourselves informed about the same because it changes from time to time.  Now, in India it changes; in Europe it changes; in the US it changes but with different frequencies.

You spoke of reaching out to the doctors across the country, do you have a strategy for doing it?

Today we are talking about rheumatology, so rheumatoid arthritis is a very difficult disease. The challenges for the disease are still high. The knowledge of the doctor prescribing the therapies or helping the patients with rheumatoid arthritis is very important. So, in our case, rheumatologists are the one who are allowed to prescribe it.

Our strategy is to make sure that we’re in front of those doctors and put in them the education they need. Now, when it comes to rheumatoid arthritis specifically, we know that we can do that. Doctors have more depth of understanding of autoimmune disease and then the patient of course partnering with them, will leverage the knowledge about the drug.

Now your focus is on autoimmune diseases, so rheumatoid arthritis is just one of them, which are the other diseases you’re looking at?

That’s a very good question.  When it comes to autoimmune, there are different series of specific diseases.  Now, today is about rheumatoid arthritis.  In our pipeline we have 22 in Phase 1, 10 in Phase 2 and 7 in Phase 3.  All the drugs we have are meant to be made available to countries around the world including India.  Some of them are in the oncology space, some of them are in the diabetes space and some of them are in the autoimmune segment.

What are the major challenges in managing autoimmune diseases?

What we have learned is when it comes to autoimmune disease is that the challenge is big. We don’t know where they come from and there isn’t honestly a cure. So, our effort is how do we help the patients mitigate their symptoms and feel better and come back to life as normally as possible. So, when we come to Olumiant today, to me the important piece is that we know for what the patient is indicating, so the one that does not respond well to conventional drugs receives help. The fact is that it is an oral therapy and is lasting. The second part is the solid data. 37 countries and 3500 patients in the clinical studies prove that there is a quicker set and it is very important when you’re so frustrated about how your life is going on for the pain and it actually has a significant number of people suffering from it. Finally, it’s great that the availability is there and we’re happy that we have been able to make it available in India.

In the top 10 markets what is your focus area and where does India stand?

Okay. Well, as you may imagine, there is a lot of focus on the US, a lot of focus on Europe and in East Asia or Japan.  For Southeast Asia, definitely for all diseases 100 per cent, but clearly India holds a very-very important piece in terms of the unmet needs. I come back to the point which is not by chance, because considering the size, considering the amount of the need for drugs in India, clearly as a company that wants to make drugs available, this is top priority for us.