Spray insulin war heats up

>Biocon​ will also produce the insulin that is used in Bentley's novel product and the two companies have already been working together for several years on this project.

>Bentley​ already entered into a similar licensing agreement in April this year with Dong Sung Pharmaceuticals for the South Korean market, where they have since been making plans to place a regulatory filing for the product there.

This is another in a series of non-injectable insulin products that has blockbuster potential and works by the insulin particles being inhaled through the nose, which are then absorbed by the nasal mucous membrane.

Non-injectable insulin will revolutionise the lives of countless diabetics and improve diabetes control, as the idea of injection deters many sufferers from taking the insulin they need.

Current estimates put the number of people with diabetes worldwide at nearly 180 million, a number which is expected to jump to 300 million in the next 20 years, and analysts predict that that first non-injectable insulin to reach major world markets stands to achieve sales upwards of $1.5 billion (€1.28 billion) a year.

For years, the big pharmaceutical companies have been racing to develop a marketable non-injectable insulin product. A range of such products are soon set to explode on to the market, ensuring a range of choice for consumers and a bitter grapple for market share.

A number of pulmonary inhaled products are already in late-stage trials and one, Pfizer and Sanofi-Aventis' Exubera, has just been given US Food and Drug Administration (FDA) approval.

However, fear of side effects seen with these inhaled products - the result of lung function testing in animals - could limit the use of these products and leave room for other delivery approaches.

Small player Generex has recently launched its novel oral (buccal) insulin spray product, Oral-lyn, in South America, however, its launch on the lucrative US and EU markets could be years away as larger Phase III trials have not yet begun.

Bentley appears to have taken a similar approach to Generex, by launching its product first on less regulated markets before coming back to tackle the EU and US.

"We chose to work in India because Biocon is one of the world's largest producers of insulin and can provide us with a ready source of the insulin that is used in our product that is already approved in India and Asia,"​ James Murphy, Bentley's chairman and CEO, told In-PharmaTechnologist.com.

"The company is currently in discussions with regulatory authorities and potential licensing partners in EU and US,"​ he said.

At this stage the company has no plans to move into South America, and compete head to head with Generex's buccal delivery product.

Scientists have known for years that the intranasal route of administration of therapeutic agents was a highly efficient route, but success in this route of administration has been difficult due to low delivery payload, poor reproducibility and/or mucosal irritation.

"We have successfully developed an intranasal product that is more bioavailable than both the pulmonary inhaled and buccal insulin products coming on to market,"​ said Murphy.

"Initial studies have shown that our product has a bioabsorption of 20 per cent compared with only 6-8 per cent for pulmonary inhaled insulin - that is a 3-4 times greater bioabsorption,"​ he said.

The company also expects its product to be cheaper compared to other non-injectable insulins, as it requires less insulin delivery. Because of this it will also be a more compact product, measuring 2.5 inches compared to other inhaled products that measure about 8 inches, said Murphy.

"We believe we can be very competitive in this market,"​ he said.

However, Phase III trials will only begin after initial characterisation trials have been completed in early 2006.

These trials will be conducted in India and the company hopes the product will be available on the market there shortly after the trials are completed.