The Hindu Business Line : Biocon to begin phase 2 nasal insulin trials

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Bangalore Feb. 20 Biocon Ltd has announced that Nasulin, an intra-nasal insulin spray it is developing with Bentley Pharmaceuticals Inc., will enter phase 2 trials in the country in March this year.

The Drugs Controller General of India has cleared Nasulin for phase 2 trials on type-2 diabetic patients, a company release said.

Biocon's subsidiary, Clinigene International, will conduct and complete clinical trials by the end of the year. Bentley has completed pharmacokinetic clinical studies with Nasulin in India and expects to close a significant portion of the US phase 2 studies by the end of 2007.

Nasulin is the second non-injectable insulin that Biocon is working on, besides the oral tablet-form insulin IN 105, which is almost on a parallel track at phase 1C. Both the drugs may be 3-4 years from commercial stage, according to Mr Rakesh Bamzai, President, Marketing. "Biocon truly believes that non-injectable insulins will drive the future of diabetes therapy the world over," he said. The company wants to play a big role in the insulin market, currently valued at nearly Rs 300 crore in the country, he said.

Insulin major Novo Nordisk is pursuing Aerx, its inhaled version, expected to be out in two years; Pfizer has already released its inhaled insulin, Exubera, in the US. Mr Bamzai said Nasulin would be absorbed through the mucus membrane into the blood stream.

According to Dr A.S. Arvind, Clinigene COO, "Phase 2 clinical studies for this product will consist of 80 patients and will be conducted in six centres in India under the direction of top clinical investigators. The patients will self-administer Nasulin spray three times a day for 12 weeks."

As per their licence agreement, Biocon is to develop and market the product in India and other markets. It has provided basic insulin crystals for the studies and Cardinal Health has packaged them for use.

Bentley is focussed on advanced drug delivery. Its President, Mr John Sedor, said: "This expansion marks an incremental milestone in the clinical development of Nasulin."

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