Performance, Unethical Practices, Performance, Products, and Services

1. BIOCON – India’s Own Home-
Grown Biotech Company

2. Two subsidiary companies – Syngene and
Clinigene International Limited
Integrated Innovation Approach
Leading Indian Biopharmaceutical company, established in 1978 by
Kiran Mazumdar-Shaw
BIOCON – AN OVERVIEW
Over the 30 years, have evolved from enzyme manufacturing unit to
fully integrated biopharmaceutical enterprise, focusing on health
care.

3. Biocon’s Performance
Biocon, India’s home grown biotechnology company, has
shown exemplary performance since its inception.

4. Biocon’s Performance
Increase in its net profit
at INR 475.1 million for
3rd qtr, 2006
Revenue and profit of
INR 1080 million in
2006-07
Growth of Biocon scrip
on both bourses
Closing at 410.25 at
BSE and 410.45 at NSE
Passed phase I of human
clinical trials and was
about to enter phase II
44%
INR 8630
Million
10%
INR 75
Oral Insulin
program

5. Biocon’s Performance
Biocon becomes
the first Indian
biotech company to
receive US funding
for proprietary
technologies.
1989 1993 1994 1997
ISO 9001 Certification
from RWTUV,
Germany, is given to
Biocon’s R&D &
Manufacturing
facilities in Bangalore.
Biocon establishes
its subsidiary –
Syngene
International Pvt.
Ltd.
Biocon takes
initiatives in human
healthcare through
a dedicated
manufacturing
facility.
Biocon becomes
the first company
to manufacture and
export enzymes to
US and Europe.
1979
Biocon’s highly
successful IPO in
March 2004 exceeds
the $1 billion mark
on the day of listing a
record
2004 2006 2012 2016
Biocon Ltd. Launches
India’s first cancer drug
BIOMABb EGFR
Biocon reports
revenue of Rs. 2087
Crore
Biocon sets up
another subsidiary –
Clinigene, to pursue
clinical research and
development
2000
Becomes the first
Indian company to
launch
a biosimilar Insulin
Glargine pen in
Japan

6. Biocon in news recently
Chairperson- BIOCON
India’s mother of
invention
India’s Biotech Queen
Biocon’s Syngene enters
into research
partnership with
Bristol-Myers Squibb
on 14 March 2007
Biocon Limited
unveiled
comprehensive
portfolio of renal
therapy products on 8
March 2007
Biocon grants exclusive
marketing license for
BIOMAb EGFR for
Pakistan on 18 January
2007.

7. Biocon in news recently
Biocon Limited and
Neopharma signed
MoU for a joint venture
on 5 January 2007
Biocon buys US-based
start-up IATRICa Inc in
a sub- $10 million deal.
Biocon buys 70 per cent stake
of the German pharma
AxiCorp in a €30-million deal
to market its injectible
insulin, generics, biosimilars
and biologics

8. Biocon & its subsidiaries
• 99.99 Percent owned
subsidiary of Biocon
Incorporated.
• Paid-up capital was
INR 28.75 million.
• 100 percent owned
subsidiary of Biocon
Ltd.
• Paid-up capital was
INR 5,00,000.
• BBPL is a joint
venture company of
Biocon.
• Paid-up capital of
BBPL was INR 8.8
million.

9. Products & Services
Kiran Mazumdar
Shaw, the founder of
Biocon, firmly
believes that India
should make full use
of her intellectual
capital.
The policy perspective
that trigged the growth
of Biocon over the past
three decades.
Biocon’s range of
products and partnered
services continue to build
a robust pipeline of
biosimilar and discovery-
led biological programs.
Mazumdar Shaw
announced on 18 June
2007 that the company
decided to sell the division
to the Danish firm
Novozymes for $115
million.
Biocon will put some
of the sale proceeds
into R&D and some
for acquisitions.

10. Products & Services
BIOPHARMACEUTICALS - Biocon manufactures
a wide spectrum of biopharmaceuticals.
ENZYMES - Biocon manufactures and markets a
broad range of industrial enzymes, food additives
and process aids.
FOOD ADDITIVES - Food additives
manufactured and marketed by Biocon include
emulsifiers, hydrocolloids, natural colours,
speciality fats and specialized proteins.

11. Services
CUSTOM RESEARCH CLINICAL RESEARCH BIOCON’S CORPORATE
SOCIAL RESPONSIBILITY
(CSR) ACTIVITIES
Leverages its synthetic
chemistry skills to carry
out custom research in
early stage drug discovery
and development
Clinigene, conducts phases
I– IV clinical trials and
longitudinal research to
discover novel biomarkers.
Biocon Foundation that has been
established with the aim of
identifying and implementing
projects that impact the social and
economic scenario in the country.
It main focus areas are to provide
quality healthcare and health
education for the betterment of
Indian society

12. Clinical Trials & drug testing in India
Biocon Outsourcing Clinical
Trials
Clinical research was
estimated to be a $5–6
billion in market
2002
Clinical research was
estimated to be a $20
billion in market
2007

13. $ 25.6 Billion
2006
2011
$32.1 billion
14%peryear
2006
2010
$ 300 Million
$1.5-2 Billion
•Human beings from developing
countries are being used as
guinea pigs and are paid a
pittance for the huge losses in
health and life suffered by
them.
This is because in countries
like India, there are teeming
millions of people who are
extremely poor and could be
paid a small compensation
compared to the citizens of
developed countries.
The drug industry has also
involved uninformed, non-
consenting people from
developing countries as
human volunteers.
Clinical Trials & drug testing in India

14. The Indian Advantage
Cost Savings
40% of the drug development cost incurred in clinicals trials in India offers
immense savings
India’s 34 Million Diabetic population and the no. keeps increasing every
year
India’s Health Infrastructure
Illegal Clinical Trials

15. Why are MNC Drug companies flocking
to India ?
Medical
scientists mostly
reverse-
engineered
drugs already
developed in
advanced
countries.
multinational
pharmaceutical
companies have
assured profits
in the Indian
market, and the
country has
suddenly
become a
profitable
location for the
expensive tests
required for
FDA’s clearance
of any drug.
multinational
drug companies
are resorting to
illegal clinical
tests in India
because of the
ever increasing
cost of drug
research both in
Europe and the
United States
India and China,
governments are
not too careful
to ensure that
such clinical
tests do not lead
to human
suffering and
death.
the
compensation
paid to the
victims’ families
work out to be a
small fraction of
what it would
have cost them
in developed
countries.
Companies are
attracted to
India not only
because of the
huge patient
pool and skilled
workers, but also
because many
potential study
volunteers are
‘treatment
naive’.
doctors here are
easier to recruit
for trials because
they do not have
to go through
the same ethics
procedures as
their Western
counterparts.
in countries like
India patients
ask fewer
questions about
what is going on.

16. Unethical
Practices of
Biocon
Rave reviews in the Media for innovative
initiatives in Biotechnology
It attracted adverse critical comments
for underplaying ethical issues
The ethical lapses have been reported
in the media
Biocon has accepted some lapses,
justified some & contested others

17. Illegal clinical trails by Biocon
Biocon + Shanta Biotech conducted illegal
clinical trials leading to 8 deaths.
Shanta failed to obtain proper consent from
patients while testing a drug meant to treat
heart attacks
Biocon tested genetically modified insulin
without approval of DCGI & GEAC

18. Environmental Infractions
• Biocon set up a manufacturing
facility at Vishakapatnam,
Andhra Pradesh in 2007
• It had also decided to set up 10
acre plot in Hyderabad biotech
SEZ by APIIC which has an
advanced marine discharge
facility with uninterrupted
power & water supply
• Biocon’s Bengaluru plant still
runs without effluent treatment
plant which is the alleged reason
to move the company to Andhra
Pradesh.

19. Biocon enhances trade operations in
Bangladesh
• Bangladesh has an increasing dependence on lifestyle
disorder drugs e.g. Cardiovascular & anti-diabetics
• It is an attractive destination for (API’s) Active
Pharmaceutical ingredients
• Biocon’s products are manufactured under ‘stringent
standards’ & therefore company’s API’s are accepted
globally by leading companies
• Biocon’s statin portfolio, oral anti-diabetics and
immuno-suppressants are on the list of exports to
Bangladesh
• 50% of Earnings constitute of Exports, for Biocon
• Biocon finds ease in business establishment in
Bangladesh due to lack of pollution norms and ease of
conducting clinical trials without objection from the
government

20. Procedural lapses at Biocon
• Biocon skipped steps and changed the process of
making Methylcobalamin, (a form of vitamin B12 used
to treat nervous problems) by using an intermediate
drug dimethyl benzimidazole imported from China
• The State Drugs Controllerate cancelled Biocon’s
license in January 2006
• On 10 February 2006, Biocon applied for a fresh licence
and received it in March
• Company admitted its procedural lapses and restarted
production of Methylcobalamin with the new license

21. • Though Indians are happy about Biocon’s achievements, criticisms against
unethical practices would tarnish the image of the country’s producers &
their products.
• Biocon must focus on providing affordable medicines available through its
innovative practices.
Conclusion

22. Thank You