Date:22/07/2005 URL: http://www.thehindu.com/2005/07/22/stories/2005072217480300.htm

Karnataka - Bangalore

Oral insulin in the offing

Special Correspondent

Biocon developing what could be the most effective way to treat diabetes

BANGALORE: Pharmaceutical major Biocon is close to developing oral insulin that will free millions of insulin-dependent diabetic patients from taking insulin shots two or three times a day.

"Orally delivered insulin could perhaps be the most medically effective and easy-to-use treatment for diabetes. It has the potential to become a proprietary 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 end of the year, 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.

Oral insulin when consumed gets absorbed to the extent possible and the rest is rejected by the body as waste. "It targets the liver which is the main organ for the control of sugar in the body," a company official said.

He said Biocon was discussing with two pharma majors for licensing rights though many have lined up.

"At present, we are in discussion with two parties for licensing rights. If we get a great offer, we will look at licensing opportunities by next year," Ms. Shaw said.

Insulin is most beneficial when it is given as soon as a person is afflicted with diabetes. Pancreatic failure can happen early, even when one is in the early 30s.

"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 bioavailability in an oral dose is likely to be in the range of five per cent to 10 per cent when compared with 70 per cent to 75 per cent for an injection.