Generex Biotechnology gets approval to market oral insulin spray
Canadian buccal delivery specialist Generex Biotechnology Corporation says that Oral-lyn, its proprietary oral insulin spray formulation, has been approved for commercial marketing and sale by the Ecuadorian Ministry of Public Health for the treatment of both Type-1 and Type-2 diabetes.
Canadian buccal delivery specialist Generex Biotechnology Corporation says that Oral-lyn, its proprietary oral insulin spray formulation, has been approved for commercial marketing and sale by the Ecuadorian Ministry of Public Health for the treatment of both Type-1 and Type-2 diabetes.
Oral-lyn is delivered via the company's proprietary RapidMist device into the human mouth where it is absorbed with no lung deposition. Generex believes that Oral-lyn offers a safe, simple, convenient, fast and effective alternative to prandial insulin injections.
Generex's South American joint venture partner, PharmaBrand, is making preparations for the commercial launch of Oral-lyn in Ecuador this year. There are approximately 360,700 adult patients with diabetes in Ecuador, according to International Diabetes Federation figures for 2003).
In addition, the company is continuing its efforts to secure the participation of a multinational pharmaceutical co-marketing partner for the rest of South America. Generex believes that this approval will pave the way for additional jurisdictional approvals around the world. It expects to be in a position to commence Phase III clinical trials of Oral-lyn in Europe and Canada later this year.
'This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales,' said Anna Gluskin, Generex's president and ceo. 'It will also enhance our ability to procure additional similar jurisdictional approvals around the world.'