Coronavirus drug, Biocon's Itolizumab, has been approved by the Drugs Controller General of India (DCGI). The medicine has been in the news for reducing the mortality rate in Cuba. The full course will cost Rs 35,000. It is a drug that is used in India for treating psoriasis and has been repurposed for Covid-19. Executive chairperson of Biocon, Kiran Mazumdar Shaw, spoke exclusively to CNN-News18 on why the cost is not steep and how this drug can save lives. She also said that the health sector deserves the same sops and incentives as the IT sector now, and the pandemic has shown that.
The DCGI has given approval to Itolizumab. Tell us what the clinical data trials showed.
At a time of an emergency, the need of the hour was to look for any treatment that is saving lives. We are inching towards the million mark and we have over twenty-two thousand people dead. We need to save lives. Even if the infection goes up, can we reduce the mortality rate is the big question. In recent times we have come to know that the virus acts very strangely. It acts to hyperactivate the immune system to create a cytokine storm. Itolizumab is positioned as a biologic molecule to prevent the cytokine storm and get rid of this. The way this acts is by modulating the immune system upstream to prevent these cells from producing cytokine. Small clinical trials we did under the emergency criteria are allowed because the need of the hour is to get access to such life-saving drugs. We have seen a very statistically significant outcome between the control arm that did not receive Itolizumab and the arm that did. All 20 recovered with the drug and in the arm it did not cover, three patients died. This is statistically significant. The modelling used to conduct such trials is very robust. The DCGI has given us permission to use this for moderate to severely ill patients from Covid-19, for those suffering from acute respiratory distress syndrome.
What about phase 3 of the trial? When is that expected?
We don't need to do a phase 3. This is a pivotal story. The drug is already approved and we went through phase 1, 2, 3, 4 for this drug because it is being used for treating psoriasis. This is a label extension. It is an emergency now and we were able to do it under the emergency category. We need to continue to capture data as always as is done in phase 4 trials and that will substantiate the data. While this trial was going on, many doctors around the country basically used this drug off-label like they are using Tocilizumab off-label, and have treated 150 patients who have all recovered. The fact is that this drug is saving lives and is working the way it should.
The cost of the drug is on the steep side. It costs Rs 35,000 for a dosage.
I think people who are commenting on the price don't understand that we have to save lives. Because, as you know, having patients in the ICU is very expensive. Having a patient on ventilator would cost you much more. Similarly, if you can save these people and discharge them, the cost-saving you will do will be far, far greater than the cost of this drug. Please look at this context and understand that saving lives is of utmost importance. The government is very pleased and believes that this is an affordable drug to save lives and to prevent additional costs that are involved in keeping these patients on ventilators.
What about the dosage?
This drug is a 25 mg formulation which is being used at about the rate of 4 vials per patient. And a patient requires one treatment. This is given in a hospital setting as an infusion. That is the way this drug is delivered. The infusion rate has to be controlled.
This drug is made in India, it has been manufactured here. But this drug has reduced the mortality rate in Cuba. Is the expectation the same here?
This is a drug molecule that I licensed from Cuba and we in India developed it and got it approved for that indication as well. While we were doing this trial, we got to know that the company from whom we got the licence was also doing it to treat Covid. The mechanism of action is very unique for this medicine. Cuba reported that its mortality rate is very low, thanks to Itolizumab. So we then started comparing our data to theirs and it is very reassuring to know that they used Itolizumab on very severe patients. We used it on moderate to severe patients. The data is very consistent. If Cuba can reduce its mortality rate, so can we.
Karnataka is undergoing a lockdown yet again. Bengaluru city was being hailed as one of the metros that did very well in controlling Covid-19. What went wrong?
We did a fantastic job when we were in lockdown. There was a good protocol that we were following. Every outbreak was pounced upon. Every positive patient was tracked in a holistic and systematic way, and for every patient infected they could actually track up to 28 contact persons. That was very impressive. That worked very well during the lockdown, but somewhere there was complacency. During unlocking they stopped contact tracing to that extent so they would only contact trace to a family of 3 and 4 and they started reducing testing and a lot of wrong decisions were taken that has led to a surge in cases which has triggered the need for a lockdown.
Lastly, what opportunity do you see in this crisis? You have said in the past that health is the new IT sector. What are the kind of investments to be made and what are the opportunities waiting to be explored in this sector?
At a general level, we need to invest in healthcare for the public by increasing the spending to at least 2%. Other than that, the industry requires a large number of incentives and sops, very similar to the ones that were given to the IT sector which grew in scale and size, to the dominant force it is in the world today. The healthcare sector should have the opportunity to do the same in India.
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