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Madhumathi D.S.

Bangalore , Oct. 14

INSULIN sans the tears and the pain could well be the stuff of medical fantasies. That is just the dream that the who's-who of the pharma world is chasing.

The good news for the millions of insulin-pricking Type 1 diabetics is that in a few years' time, they may be either inhaling or orally consuming their medicine, courtesy the likes of Eli Lilly, Novo Nordisk and Pfizer-Aventis. The Bangalore-based Biocon India, with plans to be a major insulin player, is the only Indian company to join the non-invasive insulin race.

For each of them, an injectionless insulin will be a big breakthrough and at least one contender may touch the post first around 2005.

The challenges to the product stage are too many and each of the majors has tied up with a third company for technology or insulin.

Eli Lilly is working with Alkermes to develop inhaled formulations. The pulmonary insulin programme based on Alkermes' AIR technology is undergoing Phase 2 clinical trials and the product could be ready in 2006-07 at the earliest, according to Mr Rajiv Gulati, CMD of Eli Lilly & Co (India).

Its Danish rival Novo Nordisk is developing its pulmonary delivery system AERx iDMS in collaboration with Aradigm Corporation, US. Aradigm holds the patent for the breath guidance technology that conveys the precise amount of the drug to the targeted spot in the lung and its technology has gone beyond the lab stage. Novo said it had an edge over the others in the non-invasives race as its inhalable version would use strips with insulin in liquid form - which is said to offer a better dose adjustment than as in powder form.

Pfizer is developing its inhalable type Exubera and has tied up with Aventis to source insulin crystals.

India, with its highly diabetes prone population, could also figure high on the clinical trials of these projects. In February this year, Biocon announced it has tied up with technology holder for oral insulin, Hannah Research Institute of Scotland, and its offspring venture, FFAST Solutions. Biocon's subsidiary, Clinigene, will conduct the human clinical trials. The CMD, Ms Kiran Mazumdar-Shaw, expects the product to be ready around 2005-06.

As for Eli Lilly, "There are no firm plans at the moment with regard to Lilly India participating in (the global Lilly clinical trials). As the programme progresses, Lilly India would be open to the possibility of conducting a trial" within the country, Mr Gulati told Business Line.

The spend on the non-invasive option is as high as the aspirations. If Lilly has put in $1 billion in its US plant to ramp up insulin crystal capacity, Biocon is investing nearly $2 million (around Rs 10 crore) in R&D and clinical development.

Ms Mazumdar-Shaw said globally, theirs will be only the second such project on an oral version for both Type 1 and 2 diabetes. The project "will only start generating some indicative data in 12-18 months' time."

According to her, "Oral insulin is a daunting challenge and the chances of commercial success are really slim. We have so far conducted animal model studies with our oral insulin preparations which have confirmed hypoglycaemia" - results that are encouraging but still have way to go.

Juvenile diabetics would be the biggest beneficiaries of a non-invasive insulin option. With the incidence of diabetes growing each year and feared to go over 330 million patients worldwide by 2025, new therapies like inhaler insulin can make a big difference in treating them, Mr Gulati said.

The bad news: as if to counter the ease of delivery, the non-injectable insulin will definitely not be a mass product. The inhalable or the oral delivery system will be much more costly that a simple injection as it will need at least five times or more of the drug.

"The best bioavailability (amount of drug delivered to the body) that we can hope to aim for in an oral preparation is 5-10 per cent compared with 70-75 per cent for an injection," Ms Mazumdar-Shaw said.

There are other hurdles like safety. The pulmonary version, for example, has to clear doubts about lung fibrosis as insulin is a growth factor. "If inhaled insulin is approved by 2005, this is a great success for non-invasive insulins," said an industry watcher.

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