Bangalore: The global phase III study for Biocon's recombinant human insulin (Insugen(R)), in Type 1 diabetes mellitus patients, has demonstrated comparable safety and efficacy with the innovator product. Bangalore-headquartered Biocon is one of Asia's premier biotechnology companies.

Research and development expenditure has risen significantly for Biocon this fiscal. The amount invested stood at approximately $14.6 million* (Rs 79 crore) for the first half of 2012-13, a 54 percent increase over the same period last fiscal. "This reflects the progress made by our various biosimilars and novel molecule programs in the clinic, including a European phase III trial for rh-Insulin which has generated positive interim data," said Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon. " Whilst this has muted profitability, research and development remains a key investment to drive exponential growth in the future."

Biocon posted close to five percent year-on-year (YoY) jump in net profit in the second quarter of fiscal 2012-13. Dr Mazumdar-Shaw commented that the company has delivered good performance across verticals this fiscal (2012-13). "At the half year, we have seen a 23 percent YoY increase in revenues attributable to both volume growth as well as better export realization on account of a depreciating rupee. APIs and biosimilar insulins have seen significant business expansion in the emerging markets. Branded formulations and research services continue to deliver strong growth," she said.

The multi-center, randomized study of the recombinant human insulin was conducted in nearly 300 patients to compare efficacy, safety and immunogenicity of Insugen R(R)) and Isophane human Insulin (Insugen N(R)) against the innovator products (Actrapid(R) and Insulatard(R)) sourced from Europe. The trial met its efficacy end-point by demonstrating non-inferiority in HbA1c endpoint at 6 months. Immunogenicity and safety as evaluated by hypoglycemic events at the 6 month time point were also similar.

The part II of the study to demonstrate additional safety and immunogenicity over one year is on and is expected to be completed by next year with the final results expected in first half of fiscal 2013-14.