Download Oral-Lyn - Oral Insulin for Types 1 and 2 Diabetes

Oral-Lyn - Oral Insulin for Types 1 and 2 Diabetes
Under development by Canadian company Generex Biotechnology, Oral-Lyn is an oral spray
formulation of human insulin indicated for the treatment of type 1 and 2 diabetes.
Having secured regulatory approval in 2005 for clinical use of Oral-Lyn in type 2 diabetics in
Ecuador, the company is keen to progress phase III trials in the major North American and
European markets, where it hopes eventually to achieve comparable success.
The announcement to start Phase III for Oral-Lyn in North America was made on 7 April 2008,
beginning with patient screening. The first screening was carried out in Texas in late March 2008.
Other clinical sites taking part in the study are located in Maryland, Minnesota, California and in
the province of Alberta in Canada.
Generex's Oral-Lyn is a liquid formulation of human insulin that is sprayed into the mouth using
its proprietary RapidMist device. In the mouth the insulin is absorbed via the buccal mucosa, an
area with a rich vasculature. Generex believes that Oral-Lyn will provide an effective alternative to
prandial insulin injections and improve patient compliance with insulin therapy.
"The need for regular daily injections is a major drawback for diabetic patients and can reduce
compliance with treatment."
Plans are underway for Phase III trials in Canada and Europe to be followed by similar largescale studies in the US. On 11 March 2008 Generex announced that the labelling and packaging
of cannisters for Oral-Lyn had been completed. The cannisters will be used for Phase III clinical
trials in the US, Canada and Ukraine.
Generex has received approval for commercial sale of Oral-Lyn in several countries. In India,
approval was obtained in November 2007. The first commercial order was made by Generex's
Indian distributor Shreya Life Sciences in March 2008 for 210,000 cannisters of Oral-Lyn.
On 1 April 2008, Generex signed a licence and distribution agreement with SciGen. Under this
agreement, SciGen will acquire approvals for importing, marketing, distributing and selling OralLyn in China, Hong Kong, Indonesia, South Korea, Malaysia, the Philippines, Singapore, Thailand
and Vietnam. SciGen will use its own recombant human insulin product for the sale of Oral-Lyn in
these countries.
On 14 May 2009, Oral-Lyn was launched in Lebanon by Benta SAL. It is available on the market
as a box containing one canister and one actuator. The cannister contains 400IU of recombinant
human insulin, while an actuator is a device that is used for managing the drug.