In anticipation of the submission to the Medicines and Healthcare products Regulatory Agency (MHRA) of a protocol for the commencement of phase III clinical trials evaluating diabetes treatment Oral-lyn in Europe, Generex has established a satellite office in the UK from which the company’s European clinical and regulatory development program will be administered.
Generex anticipates that its MHRA application for Oral-lyn phase III approval will be the cornerstone of its European registration program.
In addition, Generex, with the assistance of local consultants, is aggressively sourcing and evaluating prospective Oral-lyn licensing opportunities in the Middle East. In order to more effectively and efficiently facilitate the establishment of such arrangements and the consequent product registration initiatives, Generex has established a satellite office in Beirut, Lebanon.
Generex anticipates that, with the assistance of its local consultants, the Beirut office will act as a bridge for the introduction of Oral-lyn and other new and innovative medical and pharmaceutical technologies and products to the Middle East, a region often overlooked by multinational pharmaceutical concerns.
Oral-lyn is Generex’s proprietary oral insulin formulation, delivered via the company’s proprietary RapidMist device into, and absorbed by, the buccal mucosa in the mouth (with no lung deposition).