Biotech major Biocon Ltd. said it had 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 claimed to be first in class therapy with a unique Mechanism of Action (MoA) and an excellent safety profile as indicated during a 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.
The approval paves the way for the launch of the company's Alzumab in India, later in 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 Biocon's immunotherapy division. Alzumab will be manufactured and formulated as an infusion drug at the company's biopharma manufacturing facility at Biocon Part, Bangalore, the company said.
Itolizumab has shown promising preclinical and clinical efficacy in other auto immune diseases like RA, MS. Biocon aims to file a US IND in 2013 to facilitate global clinical trials in psoriasis, RA and other indications as a subcutaneous formulation. It plans to develop this molecule with a global partner for various markets across the world.
Alzumab is expected to provide a safe and effective treatment option for psoriasis, a socially debilitating disease affecting two to three percent of the Indian population. The global psoriasis market size is estimated to cross $8 billion by 2016, the company said.
Biocon Chairman & Managing Director Kiran Mazumdar-Shaw 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."
She added, "This approval paves the way for us to extend clinical development for other indications like Rheumatoid Arthritis, Multiple Sclerosis and Vitiligo. We also intend to file a US IND shortly to enable us to embark on a global clinical development plant. This is a defining moment for Biocon as it reaches a significant milestone in its mission of delivering affordable innovation to patients worldwide."
At the BSE, Biocon shares are currently trading at Rs.297.15, down Rs.1.52 or 1.61 percent on a volume of around 196,000 shares.
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