Canada’s Generex Biotechnology said it is planning to launch its Oral-lyn (insulin) product for the treatment of types 1 and 2 diabetes by the end of the month, following approval of the product in Ecuador [[14/10/05a]].

The launch of the orally-bioavailable insulin – the first non-injectable version of the drug to reach the market – will be followed by submissions for approval in other countries in South America, according to Generex. The company presented data in September showing that Oral-lyn cut blood glucose levels after a meal by 15% compared to placebo in patients with type 2 diabetes who were already receiving treatment with a sulfonylurea drug and metformin [[15/09/05g]].

Generex said it had ordered the manufacturing equipment required to supply Oral-Lyn to its Ecuadorian joint venture partner, PharmaBrand SA. The product is delivered via an oral spray device, looking much like an inhaler, called RapidMist. The drug delivery device is also being evaluated as a means of administering peptide vaccines.

In bringing the first non-injectable insulin to market, Generex has achieved something that has so far eluded the best efforts of some of the top pharmaceutical companies, although it is unlikely to beat them to the major pharmaceutical markets of the US and Europe. Analysts have suggested that the first non-injectable insulin to reach the major pharmaceutical markets could quickly achieve sales in excess of $1.5 billion dollars a year.

Generex said it intends to start Phase III trials of Oral-lyn in Canada and Europe within the next few months, and that the Ecuadorian approval will serve as a springboard for its efforts to secure a multinational marketing partner for the product.

Currently leading the non-injectable insulin pack in the world’s major drug markets are Pfizer and Sanofi-Aventis with their inhaled insulin product Exubera, which was recommended for approval in the US and Europe earlier this year [[14/10/05a]] [[09/09/05a]].

This product has been subject to a number of delays, mainly caused by regulatory requests for data to support the safety of delivering the peptide into the lungs [[03/03/05c]]. Last year, the companies presented data suggesting that diabetics taking the drug exhibited no decline in lung function after two years, and they are committed to carrying out long-term lung function studies out to 2019.

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.