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Biocon close to developing oral insulin

Special Correspondent

This could perhaps be the most effective and easy-to-use treatment for diabetes

Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon Limited

BANGALORE: Pharma major Biocon is close to developing an oral insulin that will free millions of insulin-dependent diabetic patients from the misery of taking insulin shots three times a day for the rest of their lives.

"Orally delivered insulin could perhaps be the most medically effective and easy-to-use treatment for diabetes. It has the potential to become a proprietory block-buster drug in the future," according to Kiran Mazumdar-Shaw, chairperson and managing director of Biocon Ltd.

Pre-clinical studies

Biocon has commenced pre-clinical studies in animals to evaluate the safety and efficacy of the oral insulin molecule IN 105 being developed in conjunction with a Scottish research institute, Hannah, and its offspring, FFAST Solutions. If everything goes as planned, the company expects to file an Investigational and New Drug Application (INDA) with national and global regulatory authorities by the year-end, Ms. Shaw said.

Company officials believe that the oral insulin has a better chance of getting approval from the food and drugs administrations in the U.S. and Europe. Biocon was discussing with two pharma majors for licensing rights though many have lined up.Insulin is most beneficial when it is given as soon as a person is afflicted with diabetes. Pancreatic failure can happen very early, even in early 30s, which means that a diabetic requires insulin shots thrice daily for the rest of his life. "Oral insulin opens up an entire new paradigm for the treatment of diabetes with high probability of success," Ms. Shaw said.

She, however, admits that cost would be a major factor in oral insulin treatment as it would require at least five times or more of the drug than in the case of a simple injection. The best bio-availability in an oral dose is likely to be in the range of 5-10 per cent when compared with 70-75 per cent for an injection.

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