eyes R&D and brand building
hedging strategy would allow it to face the challenges in future with a
sense of confidence and resilience.
Established in 1978, Biocon and its two subsidiary
companies, Syngene International Pvt Ltd and Clinigene International
Pvt Ltd form a fully integrated biotechnology enterprise, specializing
in biopharmaceuticals, custom research and clinical research. With
successful initiatives in clinical development, bio-processing and
global marketing, Biocon delivers products and solutions to partners
and customers across the globe. Many of these products have US Food and
Drug Administration and European Medicines Agency acceptance. Biocon
launched the world’s first recombinant human insulin,
INSUGEN, in November 2004, using Pichia expression and
India’s first indigenously produced monoclonal antibody,
BIOMAb-EGFR, in 2007.
Biocon posted a consolidated revenue of Rs 912.34 crore for the year
ending March 31, 2009 as against Rs 876.93 crore in 2007-08. The Biocon
Group’s consolidated revenue (including AxiCorp) have
increased 53 percent from Rs 1,090 crore in FY 2007-08 to Rs 1,673
crore in FY 2008-09. Consolidated revenue (excluding AxiCorp) increases
10 percent from Rs 1,090 crore to Rs 1,194 crore. The EBITDA (including
AxiCorp) grew 16 percent from Rs 335 crore to Rs 388 crore.
Unpredictable rupee depreciation induced by the global economic crisis
has adversely impacted its consolidated FY 2009 earnings, wherein
losses of Rs 147 crore on account of MTM were incurred. “The
financial year 2009 has been one of our most challenging years where
foreign currency volatility made it difficult to manage a sharply
depreciating rupee resulting in large MTM losses. This has been a
learning for us and our new hedging strategy enables us to address the
years ahead with a sense of confidence and resilience,”
stated Kiran Mazumdar Shaw, CMD, Biocon.
“Our branded formulations business under our healthcare
umbrella has made rapid strides in garnering market share for our key
brands in cardiology, diabetology, nephrology and oncology. We see this
as a high growth segment in our business strategy in future,”
The German pharma company, AxiCorp Gmbh, has contributed 29 percent to
Biocon’s revenue. AxiCorp has recently won the German AOK
tender for Metformin, which is an important milestone both in terms of
making inroads into the generics market as well as laying the
foundation for Biocon’s diabetes franchise in
The company’s future prospects are being driven by a robust
R&D engine which is making good progress in both biogenerics
and novel biologics programs. The company is all set for
significant incremental investments in these segments.
In a recent development the company’s conjugated insulin
molecule, IN-105, has successfully completed early phase clinical
trials for safety and efficacy. Currently a phase-III pivotal study for
oral insulin (IN-105) has been initiated across various hospitals in
India, consequently patient enrollment is in progress.
Biocon’s T1h (Anti CD6) monoclonal antibody program has also
completed patient recruitment for phase-II clinical trials for both
rheumatoid arthritis as well as psoriasis. On the biogenerics front,
Biocon’s development plan for regulatory acceptance of
recombinant human insulin by EMEA and US FDA is also in progress. Its
Insulin analogue, Glargine, is now set to enter into a similar
development path for global registrations.
Commenting on the outcome of the US Biosimilar Bill, Kiran
Mazumdar Shaw said, “Obama’s call for biogenerics
and affordable healthcare heralds a new era for biotherapeutics. Our
pipeline of biogeneric monoclonal antibodies and insulins supported by
a strong manufacturing base provides us with a unique opportunity to
build partnerships with key players in this segment.”
Biocon also recently launched Basalog, a long acting (24 hours) peak
less human insulin analogue, Glargine, in India. The key advantage of
this product is that it replaces other long acting insulins that do not
act for 24 hours, therefore diminishing the discomfort of multiple
insulin shots and the possibility of developing hypoglycemia (low blood
sugar). Hence, Basalog offers better glucose control with the
compliance of a single shot. The company is offering the drug at a cost
which is 40 percent lower than what is being offered by the innovators.
The affordable pricing which Biocon brings to the Indian market will
provide greater access to such a vital drug.
Biocon has tied up with Bayer for their latest technology glucometer,
Breeze 2, which allows a more convenient system of glucose monitoring.
This new glucometer has been designed to incorporate a cartridge of 10
strips which needs to be loaded just once. Patients can therefore test
themselves frequently with ease, avoiding periodic insertion of
individual strips and thereby ensure better compliance in terms of
blood glucose checks.
Biocon’s BIOMAb-EGFR, a therapeutic monoclonal antibody-based
drug, for treating solid tumors of epithelial origin, received the
BioSpectrum Asia Pacific Product of the Year Award 2008. Biocon has
also won the 2009 BioSingapore Asia Pacific Biotechnology Award for the
Best Listed Company. Biocon was selected for the award on the basis of
its significant market capital, sound business model and excellent