- Sandeep Sahney, managing director, Genzyme India, Gurgaon
Genzyme Corporation, one of the leaders in developing advanced
technologies for the life sciences industry, has ambitious plans for
India. These include launching their entire global portfolio of niche
drugs in the next three to four years, rolling out a number of research
initiatives, inking collaborative deals and in the future make India
their base for clinical development and manufacturing. In a
free-wheeling interview to BioSpectrum, Sandeep Sahney, managing
director of Genzyme India, shares various initiatives and strategic
plans of Genzyme for India.
have been some of the achievements of Genzyme India since its inception
Within 25 months of our existence in India, we have been able to bring
five novel treatments to the market. All of these meet specific demands
of clinicians in the areas of transplant medicine, osteoarthritis,
renal disease and hematology/ oncology. Besides this, we have created
an access mechanism on a compassionate basis, for our enzyme
replacement therapies (ERTs) that are the only approved and available
treatments for some of the genetic disorders. Because of our investment
in the area of clinical development, we have several ongoing programs
in India. While some of these are global trials, we are also supporting
many studies to create indigenous data on various diseases and their
progression-for the very first time in many cases.
In November 2008, Genzyme entered into research collaboration with the
International Center for Genetic Engineering and Biotechnology (ICGEB)
for the development of new, improved treatments for malaria under our
Humanitarian Assistance for Neglected Diseases (HAND) program. This
collaboration includes an innovative approach to intellectual property
rights, providing ICGEB the rights to commercially use the neglected
disease portfolio on a royalty-free basis. We have also instituted two
Genzyme India Fellowships for Excellence in Biotechnology at the
National Institute of Pharmaceutical Education and Research (NIPER)
that comes under the aegis of the Department of Pharmaceuticals,
Government of India.
Q In terms of
investments, is Genzyme looking at India as one of its prime growth
India will be one of the major markets in the coming years and we are
taking initiatives to establish our presence in the country. In two of
our most recent global launches, India has been among the first five
countries on our priority. In addition, we see India as a key player in
our global development of newer therapeutic agents and cutting-edge
therapies–be these in the areas of basic research or clinical
development or even manufacturing at a later stage. Few months back, we
have also begun work on a $100 million (Rs 464 crore) facility in China
after about five years of establishing our entity.
Q What is the strategy
behind free distribution of couple of your products and how supportive
is the Indian government towards this initiative?
We are currently providing free access of ERTs to numerous children
affected by Lysosomal Storage Disorders (LSDs) that include Gaucher,
Pompe, MPS 1 and Fabry's disease. A specially created
program-India Compassionate Access Program (INCAP)-reflects
our commitment to create awareness, helping diagnosis and facilitating
proper management of these patients. The mission of INCAP is to provide
these therapies and offer the chance of well-being to these patients as
a bridge until sustainable funding mechanisms emerge in the country.
The program has the oversight of some of the best known medical
geneticists from India as well as across the world. Of course, we look
forward to both center and state governments support to help more such
Q How well has this
strategy worked in other geographies and how supportive have those
In many societies across the world, Genzyme has started its operations
by providing free drugs to LSD patients through various charitable
access programs to give the patients a chance to lead normal lives.
However, the visible impact of these therapies on the affected children
has provided motivation for governments across the world to collaborate
with Genzyme and workout sustainable funding mechanisms. Other than the
US and western Europe, these therapies are funded by the state even in
emerging markets like Brazil, Russia, Mexico and South Africa as well
as in countries like Chile, Bulgaria and Malaysia.
Q How encouraging is the
Indian market when it comes to product launches?
Our experience has been an extremely positive one and this is due to
the product mix that we bring to the global market. We do work in the
areas of unmet medical needs and hence our therapies really offer
significant benefits to the patients in need. In these areas, we have
found a very welcoming attitude from both the Indian doctors as well as
patients who look for the best treatment options.
Q Which disease areas
are you looking at in India?
We plan to bring in our entire portfolio of products and services to
India in the next three to four years as each of them does offer
substantial benefits. And unfortunately, we do have patients in India
for practically the entire spectrum of diseases including those
afflicting developed as well as underdeveloped societies. Hence, there
is a visible need for effective management in all the disease areas
that we are working on presently. The major therapeutic areas of
interest include transplant medicine, renal, hemato-oncology,
orthopedics and genetic disorders. The relatively newer areas of
interest and development include multiple sclerosis (MS) and
Q What kind of
partnerships Genzyme looks forward to in the future?
As a company we are extremely focused on enhancing patient outcomes and
that forms the basis for all that we do. Hence, besides the requisite
domain experience-research or commercial areas-we
look for the two qualities of patient focus and ethics in our
We are actively looking at partnering in both research as well as
commercial areas and that is one of the mandates that Genzyme India has
from the corporation. We are in active exploration stage on both counts.
Q There is no
independent regulatory structure for biologic drugs in India? Is that
an issue for Genzyme?
This is certainly an area of concern as we work on some of the most
cutting-edge therapies including cell and gene therapies. There is a
definite need for right-skilling regulatory professionals besides
creating a distinct pathway for the biologics. We do realize that this
is a newer area for the regulators and we are open to sharing with them
all that we have learnt in our journey of nearly 30 years.
Q Has the global
meltdown affected Genzyme India's operations?
Not really, and in fact it has brought out the salience of building
operations in India at a faster pace.
Q What are the
achievements of Genzyme India as compared to its counterpart in China?
India and China are two different markets and the scope for fast growth
is their common feature. Genzyme is operating in China for a longer
period and hence has its own set of achievements. As far as India is
concerned, all I can say is that we are moving as per plan and as a
company, we do focus on long-term growth more than some of our
Q What is your take on
the Indian biotech industry?
Biotech industry in India is still at a nascent stage, but, it offers
tremendous opportunity for the simple reason that the global biotech
industry is less than 40-year-old. On the commercial side, the market
is becoming more sophisticated and both doctors and patients are
looking for more customized and innovative solutions to address medical
needs. In the area of research and development, there is a great chance
for us to 'catch-up' and lead, probably much more
than the conventional pharmaceuticals.
At present the indigenous efforts are directed more at the development
of biosimilars, we do see the government taking steps to foster and
support the path to innovation. From our perspective, we will be happy
to participate in some of these plans to develop newer therapies in
India and hence assist in capability and capacity building for the
Som in Mumbai