Continuous need for newer therapies to deliver better clinical outcomes in patients today: Dr. Anil Kukreja, VP, Medical Affairs & Regulatory, AstraZeneca India | The Financial Express

Continuous need for newer therapies to deliver better clinical outcomes in patients today: Dr. Anil Kukreja, VP, Medical Affairs & Regulatory, AstraZeneca India

We are pushing boundaries of science to evaluate our current portfolio in early stages of Lung cancer and Breast Cancer, Dr. Kukreja told Financial Express.com.

Continuous need for newer therapies to deliver better clinical outcomes in patients today: Dr. Anil Kukreja, VP, Medical Affairs & Regulatory, AstraZeneca India
Dr. Anil Kukreja, VP, Medical Affairs & Regulatory, AstraZeneca India

The non-communicable diseases (NCDs) also known as chronic diseases is a growing challenge in India. According to the World Health Organization (WHO), NCDs kill 41 million people each year, equivalent to 71 percent of all deaths globally. The major NCDs are cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. Several studies has revealed that the burden of NCDs has increased in India.

In the recent years, several pharmaceutical companies have enhanced their portfolio to cater to the treatment and care of NCDs in India. In NCDs like cancer early diagnosis plays crucial role in increasing the survival chances of patients. Pharmaceutical and biotechnological giant AstraZeneca has diverse portfolio like Oncology, Cardiovascular, Renal and Metabolism, Respiratory and Immunology, and rare diseases. In the last fiscal year, the company has reportedly registered a growth of 46 percent in Oncology followed by 41 percent in the Respiratory segment.

Financial Express.com reached out to Dr. Anil Kukreja, VP, Medical Affairs & Regulatory, AstraZeneca India and he talked about the company’s plans for India, major product launches, new biomarkers and therapeutic targets for lung tumours and among others. Excerpts:

Treatment of respiratory diseases is a key part of your portfolio. India shares a huge burden of respiratory diseases. What are the major obstacles and what are AstraZeneca’s key plans for India in this segment?

We are building a legacy with our original research quality inhalation portfolio in the management of asthma, and are focussed on bringing medically differentiated life changing medicines in respiratory diseases viz. severe asthma and COPD. We have initiated our participation in global clinical trials and at the same time focussed on confidence generation activities through establishment of Precision Severe Asthma clinics and protocols with help of leaders in India. Early diagnosis remains key to better patient outcomes but in most cases, diseases are detected at a later stage and by then it would have already progressed. We are deeply invested in innovation to develop sustainable ways to accelerate, improve and scale up holistic respiratory care across the country.

We recently partnered with Alveofit, a SaaS-IoT enabled respiratory healthcare platform, to offer IoT enabled handheld spirometers at hospitals across the country. Regular monitoring of lung functions and continuous engagement with care providers improve the overall treatment efficacy. The awareness around the early prognosis of respiratory distress, will help to scale up the diagnosis and treatment of lung diseases in the country.

Another important breakthrough in therapy is E.N.D Lung Cancer (Early Nodule Detection of Lung Cancer), which is a lung cancer care ecosystem in partnership with the winners of the India Innovation Challenge by India Sweden Innovation Centre – Qure.ai and Predible.

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What is your outlook on COVID-19 business in India? Are you planning to keep focusing on COVID-19 requirement or emphasise on non-covid ailments too?

We are dedicated to bring down the burden of non-communicable diseases and have world-class offering in therapy areas including cardio-vascular, renal, metabolic, respiratory and oncology. As a part of our beyond the pill solution, we are collaborating with multiple stakeholders in the ecosystem to augment access to quality healthcare and early diagnosis with the help of new-age digital solutions. We continue to prioritize on our vision to reduce the burden of lifestyle disorders and NCDs on the healthcare systems through meaningful interventions and partnerships.

In the years, what are key areas that AstraZeneca is working on with respect to the diseases prevalent in India?

Our focus is on all therapies we are present in and multiple molecules in each of these therapies are on different stages of maturity and penetration. In CVRM, we are following an integrated approach to treatments which is effective in reducing cardiovascular morbidity and mortality. In Oncology, our focus is on redefining the treatment paradigm to eliminate the terminal nature of the disease. Under Respiratory, we aim to leverage our potential to deliver scientific breakthroughs and transform the lives of people through a rich 40-year experience in respiratory science. We are working constantly to enhance the care models and treatment approach for cardiac, respiratory and cancer therapies.

What are the major product launches from AstraZeneca that we can expect in India this year?

Today, there is a continuous need for newer therapy options to deliver better clinical outcomes in patients. We have achieved a remarkable pipeline and scientific performances in the past few years, bringing innovation in treatment strategies. Keeping this at the fore, we have created the next wave of our innovative pipeline, ensuring the sustainable delivery of new products for patients with an unmet need. For instance, in HER2-positive metastatic breast cancer, we are coming up with Trastuzumab Deruxtecan, which has shown significant improvement in the overall survival rate.

We also intend to bring in another biologics product Tezepelumab with a unique mechanism of action (TSLP inhibition) that significantly reduces exacerbations in a broad population of severe asthma patients with no phenotype or biomarker limitations.

We are enhancing our understanding of the current disease biology with the aim of treating, preventing and even curing complex diseases in near future. We are also looking to get approvals for wider use of our current products as trials are showing benefits. There is a shift in the usage of many drugs today for a wider scope and we see huge potential for growth in this segment.

Examples include Dapagliflozin, an oral anti-Diabetes drug that has shown benefits in not only preventing Heart Failure but also in managing Chronic Kidney Disease (CKD). Recently, a positive data for Dapagliflozin in broader population of Heart failure is presented in European cardiology society and is being further evaluated for additional indications viz. post Myocardial Infarction

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What are AstraZeneca’s upcoming formulations, portfolios, and drugs in the pipeline for various lung cancer therapies?

We are pushing boundaries of science to evaluate our current portfolio in early stages of Lung cancer and Breast Cancer and our future portfolio from new scientific platform-antibody dug conjugates in management of advanced Lung Cancer and Breast cancer. We are also working on targeting newer mechanisms (Trop-2) to bring newer targeted treatment options in various cancers.

Earlier this week, AstraZeneca announced that Enhertu significantly delayed disease progression in the DESTINY-Breast Phase III trial. Can we expect this in India anytime soon?

Enhertu is specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca & Daiichi Sankyo. Currently it is either approved or under consideration in more than 30 countries such as US, EU, Canada, Japan, Australia etc. including India, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

We recently filed for our Regulatory approval and are hoping to bring this therapeutic option to address unmet needs of select Breast cancer patients in India.

Is AstraZeneca working on new biomarkers and therapeutic targets for lung tumours? If yes, then could you please elaborate?

Yes, we are defining new biomarkers and therapeutic targets that cut across multiple tumour types. Epigenetics represents an untapped opportunity in cancer biology for researchers, oncologists and tomorrow’s patients living with cancer. We aim to build a portfolio of epigenetic therapies to target cancer and its vulnerabilities, including inhibitors of key epigenetic processes such as chromatin remodelling, biomarking malignant targets and RNA or histone modification. Advances in Oncology over the last decade have led to a number of emerging fields, including the exploration of epigenetics-based therapies. We are investing in technology and expertise to better understand the role of epigenetics and pioneer new ways to attack cancer cells by modulating gene expression.

Our project LuNGS introduces next generation sequencing based 9 gene biomarker tests for lung cancer that helps clinicians to obtain all the targetable lung cancer biomarkers together (a targeted therapy) and take an informed treatment decision rather than going with sequential testing of different biomarkers, which is time consuming and often delays identification of right biomarker and right treatment option for patient.

What is the status of Imfinzi for Stage III NSCLC and Tagrisso for Stage IV NSCLC? Can we expect this drug in India too?

Both these medicines are already approved and available in India for patient use, we are increasingly seeing better adoption considering increasing clinical experience as well as very strong consistent data being presented in recent years as well as our patient support programs which address affordability barrier

What are your key milestones in the segment of Cardiovascular, Renal and Metabolism recently?

Under CVRM, our ambition is to stop, reverse and cure CVRM associated diseases by maximising our medicines, delivering innovative solutions and advancing our robust pipeline – fundamentally transforming care for millions of people with CVRM diseases. We recognised that collaboration is key to accelerating change, creating patient-centric approaches and tackle CVRM by reimagining patient care. Some key initiatives/milestones for CVRM are:

Project Heartbeat with Tricog: The project aims to address the unmet need for early diagnosis and intervention for patients with suspected heart attack by enabling cloud-based artificial intelligence (AI) supported interpretation of electrocardiograms (ECGs), routing patients to the nearest Cath Labs or fibrinolysis centres. The partnership with Tricog focuses on creating Hub and spoke model for early and accurate diagnosis of heart attack patients and to reduce mortality rate.

Project SEARCH: A mass screening program is rolled out for early diagnosis of Chronic Kidney Diseases in diabetic or hypertensive patients who are at high risk of kidney damage targeting over 2,40,000 patients. In India, the most common cause of CKDs is diabetic nephropathy.

Partnership with ISN: The partnership is a multi-faceted one and is a firm step towards collaboratively reducing Chronic Kidney Diseases related mortality and morbidity rate through patient & HCP education and improving kidney health for all. Under the aegis of Indian Society of Nephrology, we aim to impart right education amongst public so that they understand that early detection is crucial to slow down progression of CKDs and improve outcomes.

Launch of CKD Academy: The launch of the CKD Academy with ISN will focus upon undertaking certificate programs delivered by country’s top 30 nephrologists for about 1000 primary care physicians through three interactive modules. These modules will point towards deep education on key signs for early diagnosis, awareness and management strategies and relevant point of interventions for Chronic Kidney Diseases.

Skill for Scale: An e-learning initiative designed to equip nurses with hands-on practical knowledge and skills to practice latest patient care for managing NCDs and diabetes. The program accredited by AIIMS Jodhpur, is also supported by government bodies such as Directorate General of Health Sciences (DGHS) and Indian Nursing Council (INC). It allows nurses from across the country to register for free and learn at their own pace.

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We are looking at bringing solutions for Hyperkalemia in CKD/HF, which is one of the complications and also prevents treatment optimization. With this solution, CKD/HF patients can be managed in a better way with the existing therapies as Hyperkalemia is one of the limiting factor for optimum treatment of these patients. We are also looking at therapies for NASH (Non-alcoholic Steatohepatitis) which has a huge unmet need.

In cardiology, Dyslipidemia remains to challenge the patient outcomes for which the existing solutions are not enough. There is ongoing research with our early pipeline AZD8233 which has potential to be best in class PCSK-9 inhibitor to address this unmet need. Meanwhile the science of Dapagliflozin is evolving further with DELIVER results, expanding it to HFpEF indication. Also there is ongoing research on MI patients and in acute heart failure which are expected to be read out by 2023.

What are the challenges that MNC pharma companies like AstraZeneca face in countries like India?

The challenges faced by the entire pharma sector include the need for continued enhanced focus on research and development, a flexible pricing strategy, and lastly an encouraging regulatory environment and policy reforms. Innovative solutions are essential to continuously elevate standard of care and thereby improve patient’s outcomes. This also calls for a stronger implementation and enforcement of Intellectual Property Rights (IPR) to protect innovative life changing medicines are continuously developed and brought for Indian patients. This needs to be complimented by faster resolution of legal issues on patent infringements to provide assurance to all stakeholders on protection of IPR to encourage and nurture Innovation.

Our pricing strategy needs flexibility. In India, different socio-economic segments seek treatment through different channels. Going forward, we need to start discussing offering a well-implemented differential pricing or tiered pricing model as the first step to cater fairly to different patient segments.

To summarise, the future of innovative and science-based life science companies looks bright in India as there is enough momentum over the last two years to cover the gaps in meeting the final goal of optimal patient outcomes through their products and services.

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