Biocon, the publicly held biotechnology company, on Tuesday announced that it has received marketing authorisation from the Drugs Controller General of India (DCGI) for Novel Biologic Itolizumab, an 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 has 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 Alzumab in India, later during 2013. Alzumab is a differentiated biologic drug with a better safety profile compared to other approved biologic therapies given its low opportunistic infection rates.
A novel biologic indicated for the treatment of Moderate-to-Severe Psoriasis, Alzumab will be marketed by Biocon’s Immunotherapy Division.
Alzumab, will be manufactured and formulated as an infusion drug at Biocon’s Biopharma manufacturing facility at Biocon Park, Bangalore.
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Commenting on this development, Kiran Mazumdar-Shaw, CMD, Biocon, said, “We are excited to receive this marketing authorisation 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,” she added.
Alzumab is expected to provide a safe and effective treatment option for Psoriasis, a socially debilitating disease affecting 2-3% of Indian population.
The global market size for Psoriasis 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.