Hyderabad, Dec. 18
DIABETICS on insulin can hope to soon overcome their daily agony of injections if the Hyderabad-based Transgene Biotek Ltd succeeds in its efforts to commercialise the new drug delivery system of oral insulin.
At present, insulin is administered only by injection. The company claims to be the first in the world to develop oral delivery technology that combines several approaches.
"This technology is developed by us jointly with the scientists at the Indian Institute of Chemical Technology, Hyderabad. It involves using biodegradable novel polymeric nano-particles loaded with the target drug such as human insulin or hepatitis-B surface antigen as a new carrier to ferry the drug across the intestinal epithelial tissues," the Chairman and Managing Director, Dr K. Koteswara Rao, said.
He told presspersons here that the team of scientists has optimised the development of nano-particles encapsulating the desired protein/peptide. The specific drugs used in the oral delivery technology were insulin and hepatitis-B antigen.
"Both drugs (insulin and hepatitis-B) demonstrated, in the animal models, high stability and good bio-availability providing the desired clinical and immunological activities. With the pre-clinical trials providing the necessary data, we have now initiated steps to take it to the next stage of clinical trials in India and Europe simultaneously. It may consume four-five years for taking it to commercial scale and launch the product in the market. The chances of failure in the process are very minimum," Dr Rao claimed.
The Transgene management has initiated negotiations with a leading global pharma giant to out-license the oral delivery of insulin. "At present, the technical due-diligence process is going on and we expect the process to complete shortly. If succeeded, we are likely to get substantial amount as upfront payments and milestone payments."
The company also claims to have obtained similar pre-clinical results on oral delivery of hepatitis-B vaccine.
According to Dr Rao, the trials demonstrated the generation of anti-body titres to a single dose of oral delivery compared to that of injectable hepatitis-B vaccine.
"Transgene is the first company in the world to have developed this technology to deliver hepatitis-B vaccine through oral route," he claimed.
Further, Dr Rao said the company is currently working on four different technology platforms human vaccines, new drug delivery systems, bio generics and oncology products and expects good revenues from out-licensing technologies and molecules in the years to time.