“We plan to bring first in line treatment for acute lymphoblastic leukemia to India”

Mentioned Mr Vineet Singhal, Country Head, Shire India who shared his detailed views on his company’s activities as well as the social and policy aspects related to rare diseases

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One of the leading global biotechnology company, Shire headquartered in Dublin (Ireland,) is focused on serving people with rare diseases and other highly specialized conditions. Infact, the 80 percent of company’s annual R&D expenditure is channeled into rare diseases. In an interaction with the Biovoice News, Mr Vineet Singhal, Country Head, Shire India shared his detailed views on his company’s activities as well as the social and policy aspects related to rare diseases. Read the full interview below:


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Please provide an overview of the rare disease conditions in India. What are the major challenges and possible solutions? 

There are more than 7000 rare diseases known or reported worldwide. It is estimated that statistically one in 20 Indians may be affected by one of these 7,000 rare diseases. In a nutshell, about 70 million people in the country are suffering from some kind of rare diseases.

Rare diseases include lysosomal storage disorders, inborn errors of metabolism, immune disorder diseases like severe combined immunodeficiency or hypogammaglobulinemia, skeletal dysplasia where bones are not properly formed, blood-related disorders, neuromuscular disorders, and muscular dystrophies.

The 3As – awareness, accessibility and affordability, still present a challenge when it comes to providing treatment for rare disease patients in India. The issue needs to be addressed as a priority and the primary focus has to be on increasing awareness of these conditions amongst the medical community. This needs to be further supported with adequate means of diagnosis for rare diseases. Most importantly, it is imperative that therapies should be accessible to patients. The core commitment y of all stakeholders should lie in making a concerted effort to nurture an ecosystem that supports patients with rare diseases and to ensure these specialized conditions get timely treatment.

We understand that there is a fair level of awareness across the country of some rare conditions like haemophilia. Various efforts by the medical community, government, patient bodies and healthcare companies have been instrumental in driving this awareness. The collective efforts of various stakeholders have enabled a holistic approach to addressing the disease. There has been an increase in funding for the treatment of haemophilia around the country; from three states provided funding 10 years ago, to more than 21 states today today. The Government has also been very supportive in ensuring that the patients do not suffer from lack of access to clotting factors.

“Awareness of rare diseases is low in India as it is in other parts of the world. There is a dire need to create awareness of the importance of timely and appropriate diagnosis”

BV_icon-150x150Has India done anything so far on a national policy for the treatment of rare diseases? How much attention has been given to these diseases in any government schemes?

So far, the government has approved the first-ever national policy under the auspices of the Ministry of Health (MoHFW) for treatment of rare diseases in India. The policy will cover rare diseases, their treatment procedures and financial support for eligible patients. This is a welcome step paving a way forward to develop a better understanding on the current environment of rare disease in India. Prior to this initiative, there was no inclusion or mention of rare diseases in the National Health policy. The realities of the current situation have to be acknowledged and proper measures need to be taken when it comes to rare diseases. We feel very positive about the government efforts to create access to healthcare for all.

BV_icon-150x150What are the primary product offerings of Shire in India?

We are the champion for rare disease patients and have made a long term commitment to the India market. Our core therapeutic areas are Hematology and Immunology. We plan to expand therapeutic area leadership by enhancing commercial capabilities, increasing global footprint and broadening portfolio of best-in-class products.  Shire believes that people living with rare diseases should have the same access to treatment as those with more prevalent conditions. We want to be a champion and a voice for patients in calling for equity of access.

BV_icon-150x150How has the company performed in the last fiscal year? What are your expectations in terms of growth in the current FY?

In 2016, we took a big step forward on our journey to become the leading global biotech company focused on rare diseases. We almost doubled our annual revenue to $11 billion, increased our therapeutic areas to seven, and quadrupled our employees to approximately 24,000.

We continue to focus on commercial execution and new product launches, including geographical expansion to continue building global brands across portfolios. We intend to expand therapeutic area leadership and to broaden our portfolio of best-in-class products. We also aim to focus on the effective execution of our late stage clinical development pipeline in order to support future growth.

“For Shire, it’s critical that we are a catalyst in creating an environment that supports rare disease patients with a comprehensive program that will encompass awareness, education, diagnosis, and infrastructure”

BV_icon-150x150What are the current important business activities of Shire in India? 

Shire as an entity is advocating national policy development that supports improved access to healthcare and health innovations for those with rare diseases. To help make rare diseases a public health priority, the company collaborates with the rare disease community and other stakeholders. Drawing on our experience in enabling the provision of access to diagnosis and treatment of haemophilia, we plan to play a similar role in the treatment of lysosomal storage disorders. Shire’s extensive portfolio means we have the potential to help thousands of patients who need treatments especially for therapies that are not yet available in India. We want to make therapies accessible to patients so that they can start leading a near normal life.

We also plan to bring our oncology portfolio into the country, including a first in line treatment for acute lymphoblastic leukemia.

For Shire, it’s critical that we are a catalyst in creating an environment that supports rare disease patients with a comprehensive program that will encompass awareness, education, diagnosis, and infrastructure to provide the right treatment options. We believe the only way to make this possible is through meaningful partnerships that bring together policy makers, patient bodies, patient communities and other stakeholders around a common agenda, promoting awareness and accessibility to therapies.

BV_icon-150x150Is the company also strengthening its R&D base?

Globally we have 40 programs in our clinical pipeline, of which 80 percent in rare diseases and more than 10 in Phase III. We are focusing on developing therapies that are first-in-class, best-in-class- and new-to-class. The majority (80 percent) of Shire’s annual R&D expenditure is channeled into rare diseases. Today, our rare disease pipeline is more robust and focused, following the combination of Shire and Baxalta. This means that we can benefit from the best of both companies and build a nimble, performance-driven organisation with a collaborative approach and the patient at the centre of everything we do. There is an urgent need for the Indian healthcare system to be more supportive of innovations that make a difference to the lives of patients with rare diseases.

BV_icon-150x150What is the future outlook for the company in the Indian context?

Shire strives to support patients with rare diseases and other specialized conditions, and our strategy is to create and grow long-term value on the basis on improved diagnosis and through providing high impact medicines and therapies. We believe our commitment to advancing innovation means that we are making a significant contribution to society through the positive impact we have on the lives of patients and their families and caregivers.

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