The Hyderabad-based Saket Biotechnologies is all set to license out its NDDS technology for the oral delivery of proteins and peptides, which has huge potential in the biopharmaceuticals market.

The technology, which was developed in collaboration with the Indian Institute of Chemical Technologies (IICT), has already been granted US patent to deliver Insulin and Hepatitis B vaccine through the oral route, expected to be granted patents in the PCT countries shortly.

The technology developed by Saket involves a unique carrier system that utilizes nano-particulate encapsulation of the drug using Bio-polymer linkers and Vitamin B12 analogues. Saket jointly owns the IPR and patent rights with CSIR and has an agreement with CSIR, which gives it exclusive, perpetual and global marketing, sales, licensing and production rights over the NDDS and all the associated intellectual property.

The company, which has already completed animal safety, toxicity and bio-efficacy studies on the human recombinant insulin, has mandated Frost & Sullivan and APITCO to out-license this technology to a major global pharma company, said Srinivas Kollipara, vice-president of Transgene. "The phase I human trials are to commence during the first quarter of 2005," he added.

Saket is currently in the process of being merged with the Hyderabad-based Transgene Biotek Ltd, subject to statutory clearances. The merger is expected to take place by the end of January 2005.

Globally, diabetes has evolved into one of the most common non-communicable diseases and has taken the form of an epidemic in most developed and industrialized countries. According to the International Diabetes Federation, it is the fifth leading cause of death in most developed nations.

According to the World Health Organization, approximately 177 million people worldwide suffer from diabetes today, with associated economic costs estimated at more than $150 billion per year, and that number may double by 2025.

The formidable task of administering insulin orally has been pursued over the last several decades with a view to helping ease the pain and stress caused during delivery of insulin injections to the millions of diabetic patients worldwide. The convenience of an oral insulin product would be of significant benefit to patients and may increase their compliance in taking insulin, so important to the long-term control of diabetes, but so far no one has succeeded in bringing an oral product into the market.

Scientists have long been stymied by the difficulty of creating an oral insulin pill, mainly because the powerful enzymes in the digestive system destroy the insulin before enough can be absorbed into the bloodstream to be effective.

Srinivas said, while diabetes has evolved into one of the major non-communicable diseases, hepatitis B is fast developing into one of the major infectious diseases in the world. A study by the World Health Organization (WHO) indicates that of the two billion people infected with the virus, nearly eighteen per cent have chronic infections. These chronic infected patients are at a high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year.

The hepatitis B vaccine is currently given as a series of three intramuscular doses at specified intervals of time. The oral delivery of the hepatitis B vaccine will make it more acceptable to a wider range of people, by virtue of it being more convenient, painless and potentially safer, he added.