Bangalore
November 10, 2004 :
Biocon Limited, India's premier Biotechnology company
today announced the launch of INSUGENTM, the new generation
bio-insulin. INSUGENTM
is the world's first recombinant human (r-DNA) insulin
using a unique Pichia Expression - a yeast expression
system that secretes pro-insulin in an extra-cellular
manner and thereby enables an elegant purification process
for Insulin. Biocon is also the first Indian Insulin
producer to submit a DMF (Drug Master File) to the USFDA
(United States Food and Drug Administration). Manufactured
in Asia's largest Human Insulin Plant, INSUGENTM
is notably India's most clinically validated r-DNA insulin.
INSUGENTM will
be available in 10 ml vials of 40 iu/ml for an introductory
price of Rs. 126/-in India. The three different formulations
of INSUGENTM in
the market for the treatment of Diabetes are INSUGEN
R (regular), INSUGEN (NPH) and INSUGEN 30/70 (Biphasic).
During the first phase of the launch, INSUGENTM will be available
in Delhi, Punjab, Rajasthan, Maharashtra, Gujarat, Goa,
Karnataka, Tamil Nadu, Andhra Pradesh and Kerala.
Announcing the launch of Biocon's INSUGENTM in the Indian market,
Ms. Kiran Mazumdar Shaw,
Chairman and Managing Director, Biocon Limited said,
"The launch of INSUGENTM marks a significant
milestone in Biocon's foray into protein therapeutics.
Our focus areas are diabetes and oncology and this is
the first major step towards diabetes care. Biocon's
INSUGENTM meets the highest
global standards and we are confident of our success
in this area. The launch of INSUGENTM is the fruition of
an integrated effort of our scientists, engineers and
clinicians at Biocon. This launch reiterates our commitment
to providing biotechnology solutions for worldwide diseases".
Biocon has recently announced a tie-up with Nobex Corporation,
USA to explore and develop oral insulin for diabetes
treatment. Biocon also has a global supply agreement
for human insulin with Bristol Myers-Squibb. In addition,
the company has announced a 'Winning with Diabetes'
walk with Wasim Akram on November 14, 2004 (World Diabetes
Day) to spread diabetes awareness. Biocon also plans
to launch a dedicated portal for diabetes:
http://www.insugen.com/
on November 14, 2004.
Ajay Bhardwaj, President
Marketing, Biocon Limited said, "The launch of INSUGENTM
by Biocon represents our foray into a challenging market
environment with tremendous potential. Biocon's INSUGENTM is competitively priced
and we have the required marketing and sales teams in
place to expand the Insulin market in India as well
as promote INSUGENTM
in the international markets. We anticipate a positive
response to this product."
Added Dr. Arvind Atignal, Chief Operating Officer,
Clinigene International Private Limited, "INSUGENTM is India's most clinically
validated r-DNA insulin. Biocon has conducted a comparative,
multi-centric clinical trial on 450 patients as against
the norm of a sample size of 360 patients. In addition
to this, INSUGENTM
has also been tested for non-inferiority with existing
marketed drugs in India and is at par with global brands."
India's 32 million diabetics account for one-fourth
of the global diabetic population. The numbers are estimated
to grow to 57.2 million by year 2025. Diabetes mellitus
is a chronic disease caused by inherited and/or acquired
deficiency in production of insulin by the pancreas,
or by the ineffectiveness of the insulin produced. Biocon
now plans to expand the availability of INSUGENTM globally.
For further information contact :
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