Biocon receives marketing authorization for its Novel Biologic Itolizumab for Psoriasis

08 Jan 2013 Evaluate

Biocon, Asia’s premier biotechnology company 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 Alzumab in India, later during 2013. Alzumab 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, Alzumab will be marketed by the company’s Immunotherapy Division. Alzumab, will be manufactured and formulated as an infusion drug at Biocon’s Biopharma manufacturing facility at Biocon Park, Bangalore.

Alzumab is expected to provide a safe & effective treatment options for Psoriasis, a socially debilitating disease affecting 2-3% of Indian population. The global Psoriasis market is estimated to cross $8 billion 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.

Biocon is India’s premier biotechnology company with a strategic focus on biopharmaceuticals and research services. Biocon produces anti-diabetic agents like Acarbose, Pioglitazone, Repaglinides and Rosiglitazone. In the biological segment it produces Insulin, Erythropoietin (EPO), Filgrastim (GCSF), Streptokinase and Monoclonal Antibodies.

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