Pharma MNC Novo Nordisk has received the DCGI permission for the phase III clinical trials of its promising diabetes molecule detemir or levemir, which is one of the latest molecule in the discovery basket of the company. The company will soon be conducting phase III trials in the country. "As the molecule has undergone successful phase I&II trials abroad, DCGI is satisfied and the company is expected to produce only phase III trial results here. Novo should be completing the trials within the next 12-18 months," said industry sources.
Insulin detemir belongs to a new class of basal insulin analogs with a neutral pH and unique mechanism for prolonging action (protraction). Studies have proved that the currently available basal insulin preparations may produce variable blood glucose responses to the same dose given on different days. The distinct chemical structure of insulin detemir allows for a slower and more stable absorption from the injection site. The molecule has a fatty acid attached, enabling it to bind to albumin within the subcutaneous tissue and bloodstream and release insulin detemir at a slow, consistent rate. The risk of hypoglycaemia for insulin detemir was 0.1 per cent, while for NPH insulin and insulin glargine the risk was dramatically higher: 6.5 and 2.7 per cent respectively.
Novo Nordisk has completed successful clinical trials on detemir in US and Europe and is on the verge of marketing approval by the US FDA and the European approval authorities or EMEA. Switzerland is the only country, where the company has received the final approval towards marketing of the product, however, Novo Nordisk plans to await final approval from the European approval authorities, EMEA, before the new basal insulin analogue is launched in Switzerland.
With the broadest diabetes product portfolio in the industry, Novo Nordisk is a leading player in the field of diabetes with a market share of 14 per cent, reflecting 5 per cent in the USA, 35 per cent in Europe and 25 per cent in Japan.
The company is a fairly new player in the Indian insulin market. Eli Lilly, and Aventis are the other MNCs marketing insulin in the country. Aventis' Lantus is the advanced of the human insulin available in India today. The Indian insulin market is valued at around Rs2.5bn. Nearly, 90 per cent of insulin sold in India are derived from slaughtered pancreas of pigs and cows. USV, Wockhardt and Biocon are the largest domestic manufacturers of insulin.
India is the home to 40 million diabetics. There are currently more than 194 million people with diabetes worldwide, according to WHO.