The new product, called Oral-lyn, takes the form of an oral insulin spray and has been approved for sale by the Ecuadorian Ministry of Public Health for the treatment of both type 1 and type 2 diabetes. The regulatory applications in Ecuador were carried out by Generex' local development partner PharmaBrand, which will launch the product onto the market later this year.
In bringing the first non-injectable insulin to market, Generex has achieved something that has eluded some of the top pharmaceutical companies, although it is unlikely to beat them to the major pharmaceutical markets of the US and Europe.
In the latter territories, Pfizer and Sanofi-Aventis filed for approval of their inhaled insulin product Exubera in the US last month, after delays caused by regulatory requests for data to support the safety of delivery the peptide into the lungs. Last September, the companies presented data suggesting that diabetics taking the drug exhibited no decline in lung function after two years.
Meanwhile, other inhaled insulins are in Phase III clinical development from Eli Lilly/Alkermes and Novo Nordisk/Aradigm, while a rival product from Mannkind is in Phase II.
Generex said it intends to start Phase III trials of Oral-lyn in Canada and Europe later this year, and that the Ecuadorian approval will serve as a springboard for its efforts to decure a multionational marketing partner for the drug.
Oral-lyn is delivered via Generex' proprietary RapidMist device into the human mouth where it is rapidly absorbed into the bloodstream through the buccal mucosa, with no lung deposition.
The RapidMist system looks just like a regular inhaler but delivers aerosolised formulations of peptides or proteins using a pressurised fluorocarbon carrier. Studies have shown that the system can achieve therapeutic plasma levels of insulin within 20 minutes of dosing, making it suitable as an alternative to prandial insulin injections.
Anna Gluskin, Generex's CEO, said: "This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales. Oral-lyn stands ready to improve the quality of life for patients with diabetes through improved comfort and compliance which will also delay the onset of the many complications associated with this incurable disease."
Last year, researchers from Generex subsidiary Antigen Express showed that the RapidMist device was able to deliver two peptide vaccines against cancer and HIV to animals and stimulate an immune response.