Large-scale commercial production of Oral-lyn will begin in January, with the goal of producing 50,000 cans per month for the first year, to support initial sales in Ecuador. The company already has 20,000 cans ready for the launch, prepared by their pilot plant in Canada.
Generex is also preparing to file for approval of Oral-lyn in Columbia, Peru and Bolivia, and will further scale-up production in the second half of next year to produce over 2 million cans per year to service commercial sales in those additional markets.
The production of Oral-lyn will be carried out by PharmaBrand, Generex's joint venture partner, at it's existing manufacturing plant in Quito, Ecuador.
For years, the big pharmaceutical companies have been chasing the holy grail of diabetes therapies – non-injectable insulin. A range of such products are set to explode on to the market in the next few years, ensuring a bitter grapple for market share.
Surprisingly, small independent company Generex has beaten them all to market launch, receiving approval for Oral-lyn in Ecuador in May this year. However, it is unlikely to beat them to the major pharmaceutical markets of the US and Europe.
Companies who have developed pulmonary inhaled insulins are hot on the heels of Generex, with Exubera developed by Pfizer, Sanofi-Aventis and Nektar Therapeutics just been given US FDA approval, and similar products in Phase III clinical development from Eli Lilly/Alkermes and Novo Nordisk/Aradigm.
Interestingly, Generex was originally partnered with Eli Lilly to develop and market Oral-lyn but the deal that lasted only three years broke down prematurely in 2003.
Oral-lyn is a novel oral (buccal) insulin spray product, which is delivered into the human mouth by way of the company's proprietary RapidMist drug delivery system.
Non-injectable insulin will revolutionize 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.
“We expect to have captured 20–30 percent of the injectable diabetes market within 2–3 years,” Fabio Chianelli, development manager, Generex, told In-PharmaTechnologist.com. However, this will all depend on whether the company is able to break into more lucrative markets by getting their product approved by the tougher regulatory authorities of EU and US.
The approval of Oral-lyn was based on the results of clinical trials in Ecuador involving more than 250 patients with diabetes.
However, the large-scale Phase III clinical trials required by regulators in the US, Europe, and elsewhere have not yet begun. These studies will involve well over a thousand patients, and must include a sizeable number of patients with over at least a year's exposure to the product.
The company is preparing to start Phase III studies in Canada and Europe early next year and in the US in the second half of next year, said Chianelli.
This raises the important question as to why, if the company is confident of the quality of their product, they chose to launch their product in South America.
“Regulatory approval in South America is much more relaxed than in other parts of the world. Lunching here first is part of our aggressive two pronged strategy, to generate revenue from sales of the product in Ecuador, in order to finance larger costly Phase III trials,” said Chianelli.
“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.