This is the second novel biologic, a medicinal preparation created by a biological process, developed by Biocon at its research and development unit in Bangalore. Biocon's first biologic to enter the market was BioMab EGFR, used in the treatment of cancer.
The company said Itolizumab is a first in class therapy for the treatment of moderate-to-severe psoriasis and has an excellent safety profile as indicated during the 52-week phase III multi-centric clinical study that was conducted in India.
Biocon will market the novel biologic under the name Alzumab in India, during the latter half of 2013. Alzumab will be manufactured and formulated as an infusion drug at Biocon's manufacturing facility at Biocon Park in Bangalore.
Psoriasis is a socially debilitating disease affecting 2% to 3 % of the Indian population. Global estimates suggest that the treatment of psoriasis will have a market value of $8 billion by 2016.
Commenting on the regulatory approval, Kiran Mazumdar-Shaw, CMD, Biocon, said, "This approval paves the way for us to extend clinical development for other indications like rheumatoid arthritis, multiple sclerosis and vitiligo." The biologic Itolizumab has shown promising pre-clinical and clinical efficacy in other auto-immune diseases like rheumatoid arthritis and multiple sclerosis, Biocon said.
Shaw added, "We also intend to file a US IND (Investigational New Drug) filing 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."
Biocon plans to develop Itolizumab with a global partner for various markets across the world.
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