The approval of Oral-lyn, an oral (buccal) insulin spray, which is delivered into the mouth by the company's proprietary RapidMist system, was mainly based on the results of clinical trials in Ecuador involving only 250 Type 2 diabetics.
Oral-lyn is now available in Ecuador for Type 2 diabetics and the company hopes to soon have it approved there for Type 1 diabetes and is now conducting a six-month study in this patient population.
In addition, the firm is planning to roll Oral-lyn out in several other South American countries later this year, however, Oral-lyn's success will ultimately depend on whether it is able to break into the more lucrative international markets.
The large-scale Phase III clinical trials required by regulators in the US, Europe, and elsewhere have not yet begun and whether >Generex's product can stand up to the much tougher international standards remains to be seen.
Generex does however provide a nice case study of a biotech company going it alone and so far achieving a degree of success.
When asked the important question as to why, if the company is confident of the quality of their product, it chose to launch its product in South America, Fabio Chianelli, business development, Generex, told www.In-PharmaTechnologist.com:
"Regulatory approval in South America is much more relaxed than in other parts of the world. We launched here first to generate revenue from sales of the product in Ecuador, in order to finance larger costly global Phase III trials."
"Other small biotechnology companies are usually partnered with large pharmaceutical companies and do not need to take this route. For us, money is sensitive," he said.
Oral-Lyn also tests the water of the potential for non-injectable insulin, as the rate of uptake in Ecuador may provide some indication of how popular the big pharma's new products will be when they are eventually unleashed onto the world market.
Meanwhile, nasal insulin sprays, where insulin particles are inhaled through the nose and are then absorbed by the nasal mucous membrane, are another area of budding development.
Scientists have known for years that the nasal route of administration of is highly efficient, but successful nasal insulin products have been difficult due to low delivery payload, poor reproducibility or mucosal irritation.
Drug development firm >Bentley believes that its intranasal product has conquered these problems and is more bioavailable than both the pulmonary inhaled and buccal insulin products coming on to market.
"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," according to James Murphy, Bentley's chairman and CEO.
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.
Phase III trials will begin in early 2006 and Bentley recently signed a license agreement with Korea's Dong Sung and India's Biocon to develop and market the product in 85 countries throughout Asia, Africa, and the Middle East upon approval.
However, Dr Nancy Bohannon, who specialises in research in and treatment of diabetes in the US remains skeptical of nasal insulin sprays, due to the small area of absorption in the nose and the number of variables that could interfere with dosing such as mucous, colds and allergies.
Budding biotech firm Coremed has recently unveiled a drug-delivery platform technology, IVE (in-vivo encapsulation) that improves absorption of certain proteins and macromolecules such as insulin within the gastrointestinal tract and may pave the way for the first insulin capsule. This is still in the early stages of development.
However, again, Dr Bohannon is skeptical, as she believes that insulin absorption within the gastrointestinal tract would be too unpredictable with an insulin capsule.
Finally, transdermal insulin technologies are also in the early development phase. Japan's KSL is working on a process that uses electrical currents like insulin, across the skin. This process may be able to move up to 70 per cent of an insulin dose into the bloodstream, but at this stage appears to be a relatively slow method of insulin delivery.
As yet, none of these products pose an immediate threat to the big players in pulmonary insulin, the biotech pipeline is clearly buzzing and may well be the seeding ground of the next generation of insulin.