<p>Biocon, India’s biggest biopharmaceutical company, has been working towards finding a treatment for the coronavirus. Their drug, Itolizumab, has shown promising results and the company is working towards collatng more data so it can be used in treating Covid-patients. Kiran Mazumdar-Shaw, the founder of the Bengaluru-based company, spoke to Krupa Joseph of DH about India’s response to the pandemic, drugs in the making, and how the ‘new normal’ open up fresh opportunities for entrepreneurs.</p>.<p>Earlier this month, Kiran was honoured with the ‘Woman of the Year’ award by the Ladies’ Wing of the IMC Chamber of Commerce and Industry, Mumbai.</p>.<p><strong>Q. When do you think we can realistically expect a vaccine for Covid-19?</strong></p>.<p>A. Several vaccines are in the pipeline. Right now, of all the vaccines advancing in Phase 2 or Phase 3, the AstraZeneca vaccine looks most promising since it has not had safety concerns. The focus of the companies that are working on this is on two of our vaccines getting into Phase 1. Phase 1 data is important to see both safety and efficacy in terms of whether they induce both antibody and T-cell response. Let us hope, in the next six months, we have a vaccine in the market.</p>.<p><a href="https://www.deccanherald.com/national/coronavirus-news-live-updates-andhra-pradesh-reports-record-8147-cases-karnataka-government-changes-rates-for-rt-pcr-antigen-testing-864013.html" target="_blank"><strong>For latest updates and live news on coronavirus, click here</strong></a></p>.<p><strong>Q. What is Biocon doing towards finding a cure?</strong></p>.<p>A. Biocon has repurposed its novel biologic therapy with a unique mechanism of action. We received ‘restricted emergency use’ approval for the first-in-class anti-CD6 monoclonal antibody, Itolizumab, from the Drugs Controller General of India on July 11, based on Phase 2 clinical trial involving 30 patients. The two-arm, randomised study showed the drug’s statistically significant advantage in bringing down mortality in moderate to severe Covid-19 patients. Itolizumab has also been administered in over 150 patients under ‘off label’ use and has saved their lives. We are extremely proud that an innovative drug in India has shown such promising results. We are planning a larger Phase 4 clinical study to corroborate the results of the Phase 2 study and to expand its use for more patients. Additionally, Biocon also has a US FDA-approved innovative device, Cytosorb, currently being used in India to treat Covid-19 patients in ICU with confirmed or imminent respiratory failure. Similarly, Syngene, our subsidiary company, is operating an accredited testing centre to support Bengaluru hospitals. It has also partnered with Hi Media Laboratories to manufacture Elisa test kits for Covid-19.</p>.<p><strong>Q. What is the status of the path-breaking drugs you were developing: for example, oral insulin?</strong></p>.<p>A. The quest for a game-changing insulin therapy led us to invest in the clinical development of Insulin Tregopil, an oral insulin molecule that could mimic the natural physiology of the body by targeting the liver, which is a central organ in glucose metabolism. We believe that delivering insulin through a pill would potentially usher in a paradigm change in diabetes management by making it convenient for patients to take insulin. We are currently preparing a report on the outcome of a recently completed Phase 2 study in Type 2 diabetes in India. Additionally, for Type 1 diabetes, we commenced a multiple ascending dose study in Germany in partnership with US-based JDRF, an organisation funding research into Type 1 diabetes.</p>.<p><a href="https://www.deccanherald.com/science-and-environment/coronavirus-vaccine-live-updates-covaxin-clinical-trials-human-trials-coronavirus-vaccine%20tracker-india-russia-us-china-oxford-moderna-bharat-biotech-866148.html#1" target="_blank"><strong>For latest updates and news on coronavirus vaccines, click here</strong></a></p>.<p><strong>Q. Do you think India’s response to the pandemic has been well thought out? Where have we gone wrong, and how could it have been better?</strong></p>.<p>A. The nationwide lockdown ga</p>.<p>ve India the time to prepare healthcare infrastructure and define medical and administrative protocols to manage the pandemic. When the lockdown was lifted, most people thought that the coast was clear and ventured out unprotected. It resulted in the infection spreading fast and wide. Given the extremely high virulence of Covid-19 and the challenge of extensive contact tracing, positive cases will continue to rise till the curve flattens naturally or we develop herd immunity. Given that more than 80% of those infected have very mild or no symptoms, we should not worry about the absolute number of positive cases. We need to up the ante on surveillance and swiftly impose a quarantine, containment and hospitalisation. We also have to increase test reporting.</p>.<p><strong>What is your advice to women entrepreneurs?</strong></p>.<p>Entrepreneurship is a bold and daring path irrespective of whether you are a man or a woman. It is about being able to ideate, take risks, manage failures, sight opportunities, and understand markets. Ideas are agnostic to gender. The pandemic has thrown up enormous opportunities to conceptualise and build new businesses. From contactless services to wearables that monitor your health and safety, there is an opportunity for every aspect of the new normal. The virtual world that we have been thrown into offers women entrepreneurs a plethora of new ideas. </p>.<p><br /><strong>What does this award mean to you?</strong></p>.<p>The IMC Ladies’ Wing is one of the oldest and most respected organisations working for the cause of women’s economic empowerment. It is indeed an honour to receive the award. </p>.<p><strong>Biotech pioneer</strong></p>.<p>Kiran Mazumdar-Shaw is the chairperson and managing director of Biocon Limited, a biotechnology company based in Bengaluru. She is the recipient of two of India’s highest civilian honours, the Padma Shri (1989) and the Padma Bhushan (2005). In 2014, she was awarded the Othmer Gold Medal for outstanding contributions to the progress of science and chemistry. Her company is among those in India leading the way to a drug for the coronavirus. </p>
<p>Biocon, India’s biggest biopharmaceutical company, has been working towards finding a treatment for the coronavirus. Their drug, Itolizumab, has shown promising results and the company is working towards collatng more data so it can be used in treating Covid-patients. Kiran Mazumdar-Shaw, the founder of the Bengaluru-based company, spoke to Krupa Joseph of DH about India’s response to the pandemic, drugs in the making, and how the ‘new normal’ open up fresh opportunities for entrepreneurs.</p>.<p>Earlier this month, Kiran was honoured with the ‘Woman of the Year’ award by the Ladies’ Wing of the IMC Chamber of Commerce and Industry, Mumbai.</p>.<p><strong>Q. When do you think we can realistically expect a vaccine for Covid-19?</strong></p>.<p>A. Several vaccines are in the pipeline. Right now, of all the vaccines advancing in Phase 2 or Phase 3, the AstraZeneca vaccine looks most promising since it has not had safety concerns. The focus of the companies that are working on this is on two of our vaccines getting into Phase 1. Phase 1 data is important to see both safety and efficacy in terms of whether they induce both antibody and T-cell response. Let us hope, in the next six months, we have a vaccine in the market.</p>.<p><a href="https://www.deccanherald.com/national/coronavirus-news-live-updates-andhra-pradesh-reports-record-8147-cases-karnataka-government-changes-rates-for-rt-pcr-antigen-testing-864013.html" target="_blank"><strong>For latest updates and live news on coronavirus, click here</strong></a></p>.<p><strong>Q. What is Biocon doing towards finding a cure?</strong></p>.<p>A. Biocon has repurposed its novel biologic therapy with a unique mechanism of action. We received ‘restricted emergency use’ approval for the first-in-class anti-CD6 monoclonal antibody, Itolizumab, from the Drugs Controller General of India on July 11, based on Phase 2 clinical trial involving 30 patients. The two-arm, randomised study showed the drug’s statistically significant advantage in bringing down mortality in moderate to severe Covid-19 patients. Itolizumab has also been administered in over 150 patients under ‘off label’ use and has saved their lives. We are extremely proud that an innovative drug in India has shown such promising results. We are planning a larger Phase 4 clinical study to corroborate the results of the Phase 2 study and to expand its use for more patients. Additionally, Biocon also has a US FDA-approved innovative device, Cytosorb, currently being used in India to treat Covid-19 patients in ICU with confirmed or imminent respiratory failure. Similarly, Syngene, our subsidiary company, is operating an accredited testing centre to support Bengaluru hospitals. It has also partnered with Hi Media Laboratories to manufacture Elisa test kits for Covid-19.</p>.<p><strong>Q. What is the status of the path-breaking drugs you were developing: for example, oral insulin?</strong></p>.<p>A. The quest for a game-changing insulin therapy led us to invest in the clinical development of Insulin Tregopil, an oral insulin molecule that could mimic the natural physiology of the body by targeting the liver, which is a central organ in glucose metabolism. We believe that delivering insulin through a pill would potentially usher in a paradigm change in diabetes management by making it convenient for patients to take insulin. We are currently preparing a report on the outcome of a recently completed Phase 2 study in Type 2 diabetes in India. Additionally, for Type 1 diabetes, we commenced a multiple ascending dose study in Germany in partnership with US-based JDRF, an organisation funding research into Type 1 diabetes.</p>.<p><a href="https://www.deccanherald.com/science-and-environment/coronavirus-vaccine-live-updates-covaxin-clinical-trials-human-trials-coronavirus-vaccine%20tracker-india-russia-us-china-oxford-moderna-bharat-biotech-866148.html#1" target="_blank"><strong>For latest updates and news on coronavirus vaccines, click here</strong></a></p>.<p><strong>Q. Do you think India’s response to the pandemic has been well thought out? Where have we gone wrong, and how could it have been better?</strong></p>.<p>A. The nationwide lockdown ga</p>.<p>ve India the time to prepare healthcare infrastructure and define medical and administrative protocols to manage the pandemic. When the lockdown was lifted, most people thought that the coast was clear and ventured out unprotected. It resulted in the infection spreading fast and wide. Given the extremely high virulence of Covid-19 and the challenge of extensive contact tracing, positive cases will continue to rise till the curve flattens naturally or we develop herd immunity. Given that more than 80% of those infected have very mild or no symptoms, we should not worry about the absolute number of positive cases. We need to up the ante on surveillance and swiftly impose a quarantine, containment and hospitalisation. We also have to increase test reporting.</p>.<p><strong>What is your advice to women entrepreneurs?</strong></p>.<p>Entrepreneurship is a bold and daring path irrespective of whether you are a man or a woman. It is about being able to ideate, take risks, manage failures, sight opportunities, and understand markets. Ideas are agnostic to gender. The pandemic has thrown up enormous opportunities to conceptualise and build new businesses. From contactless services to wearables that monitor your health and safety, there is an opportunity for every aspect of the new normal. The virtual world that we have been thrown into offers women entrepreneurs a plethora of new ideas. </p>.<p><br /><strong>What does this award mean to you?</strong></p>.<p>The IMC Ladies’ Wing is one of the oldest and most respected organisations working for the cause of women’s economic empowerment. It is indeed an honour to receive the award. </p>.<p><strong>Biotech pioneer</strong></p>.<p>Kiran Mazumdar-Shaw is the chairperson and managing director of Biocon Limited, a biotechnology company based in Bengaluru. She is the recipient of two of India’s highest civilian honours, the Padma Shri (1989) and the Padma Bhushan (2005). In 2014, she was awarded the Othmer Gold Medal for outstanding contributions to the progress of science and chemistry. Her company is among those in India leading the way to a drug for the coronavirus. </p>
