Biocon Receives Marketing Authorization for its Novel Biologic

Bangalore, Karnataka, India, Tuesday, January 08, 2013 -- (Business Wire India) 
Biocon, Asia's premier biotechnology company today announced that it has
received Marketing Authorization from the Drugs Controller General of India
(DCGI) for its Novel Biologic Itolizumab, anti CD6 molecule, for the treatment
of chronic plaque Psoriasis. 
Itolizumab, is a first in class therapy with a unique Mechanism of Action (MOA)
and an excellent safety profile as indicated during the 52 week Phase III
multi-centric clinical study conducted in India. It is the second Novel Biologic
developed by Biocon at Asia's largest Biotech hub in Bangalore.  
This approval paves the way for the launch of Biocon's AlzumabTM in India, later
during 2013. AlzumabTM is a differentiated biologic drug with a superior safety
profile compared to other approved biologic therapies given its very low
opportunistic infection rates. A novel biologic indicated for the treatment of
Moderate-to-Severe Psoriasis, AlzumabTM will be marketed by Biocon's
Immunotherapy Division. AlzumabTM, will be manufactured and formulated as an
infusion drug at Biocon's Biopharma manufacturing facility at Biocon Park,
Commenting on this development Ms. Kiran Mazumdar-Shaw, Chairman & Managing
Director, Biocon said, “We are very excited to receive this marketing
authorization for Itolizumab from DCGI which will enable Biocon to introduce
this novel, first in class biologic for the treatment of psoriasis patients in
India. This is our Second novel biologic that we have developed in India, BioMab
EGFR, an anti-cancer monoclonal antibody, being the first. This approval paves
the way for us to extend clinical development for other indications like
Rheumatoid Arthritis (RA), Multiple Sclerosis (MS) and Vitiligo. We also intend
to file a US IND shortly to enable us to embark on a global clinical development
plan. This is a defining moment for Biocon as it reaches a significant milestone
in its mission of delivering affordable innovation to patients worldwide.” 
AlzumabTM is expected to provide a safe & effective treatment option for
Psoriasis, a socially debilitating disease affecting 2-3 % of Indian population.
The global Psoriasis market size is estimated to cross $8 bn by 2016.  
Itolizumab has shown promising preclinical and clinical efficacy in other auto
immune diseases like RA, MS. The company aims to file a US IND in 2013 to
facilitate global clinical trials in Psoriasis, RA and other indications as a
subcutaneous formulation. Biocon plans to develop this molecule with a global
partner for various markets across the world.  
About Itolizumab 
Itolizumab is a ‘first in class' humanized IgG1 monoclonal antibody that
selectively targets CD6 cells. CD 6 is a pan T cell marker involved in
co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to
CD6, down regulates T cell activation, causes reduction in synthesis of
pro-inflammatory cytokines and possibly plays an important role by reducing T
cell infiltration at sites of inflammation. In addition to TREAT-PLAQ study, two
positive Phase 2a dose finding studies have been conducted one each in RA and
About Biocon Limited 
Established in 1978, Biocon Limited (BSE code: 532523, NSE Id: BIOCON, ISIN Id:
INE376G01013) is India's largest biotechnology company by revenue. The Group,
promoted by Ms. Kiran Mazumdar-Shaw, is a fully-integrated, innovation-driven
healthcare enterprise with strategic focus on biopharmaceuticals and research
services. Biocon's value chain traverses the entire length of discovery,
development and commercialization of novel therapeutics. Biocon's robust product
offering includes the world's first Pichia-based recombinant human Insulin,
INSUGEN(R) and India's first indigenously produced monoclonal antibody
Media contact details 
Seema Ahuja, Head-Corporate Communications,
Biocon Limited,
+91 (80) 2808-2222/ +91 9972317792, 
Sweta Pachlangiya, Investor Relations,
Biocon Limited,
+91 (80) 2808-2045/ +91 9686509372, 
Contributed via: Bloomberg Publisher WEB Service 
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-0- Jan/08/2013 09:44 GMT
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