Biocon in talks with pharmaceutical majors

Efforts on to licence its oral insulin molecule

Bangalore-based biotech major Biocon is in talks with two pharma majors to out licence the oral insulin molecule it is developing.

Acknowledging the development, Kiran Mazumdar-Shaw, chairman and managing director Biocon group said, "We are in discussions with two pharma majors and we are unable to disclose at this point in time the status of those discussions because it is still too early to talk about it."

Biocon's oral insulin has the potential to be India's first proprietary biotech blockbuster drug and the company has initiated discussions with pharma majors for licensing the oral insulin molecule for global markets, she added.

She expalined that "I think we will decide on when we want to licence this molecule depending on the valuation that we can arrive at, during these discussions. If we are not satisfied with the kind of value they are willing to ascribe to this programme, at this stage we would rather take it up the value chain and the development chain and then re-address the licencing opportunity."

But, if the licensing deal "sounds attractive at this stage, we don't mind taking a look at it," she added.

"Data generated so far is extremely encouraging and we also expect to file an investigational new drug application with USFDA, the European regulatory authorities and the Indian regulatory authority by the end of this year," said Kiran Mazumdar-Shaw.

"This means that we will be able to conduct human clinical trials early next year," she added.

The success of this programme will open up a large global opportunity that has potential of addressing both Type I and Type II diabetes.

Currently the company has taken its oral insulin to pre-clinical development in the animal model.

The animal model study is being carried out simultaneously in US and India to evaluate safety, efficacy and to develop a proof of concept.

For oral insulin, the peptide oral-delivery model is being pursued.

For this, the manufacturing technology of US-based Nobex with the proven peptide production capabilities of Biocon is being explored.