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Published on 12/6/2005 in the Prospect News Biotech Daily.

Generex's oral insulin spray Oral-lyn available in Ecuador in early 2006

By E. Janene Geiss

Philadelphia, Dec. 6 - Generex Biotechnology Corp. said Tuesday that its proprietary oral insulin spray product Oral-lyn is being introduced to physicians in Ecuador and will soon be available through physician referrals.

Oral-lyn is the first non-injectable form of recombinant human insulin available for commercial distribution in the world, according to a company news release.

It is designed to improve the quality of life for patients with diabetes by allowing them to manage the disease more effectively. Oral-lyn is delivered by the company's proprietary RapidMist device into the mouth of the patient, where it is absorbed with no lung deposition. Oral-lyn offers a safe and effective alternative to prandial insulin injections, officials said.

Following equipment validation, Oral-lyn will be produced for commercial distribution at the manufacturing facilities of PharmaBrand SA, the company's South American joint venture partner in Quito, Ecuador.

The company said it expects the product to be widely available in Ecuador in the first quarter of 2006.

Generex and PharmaBrand have begun education and marketing programs to support the sale of Oral-lyn in the country. According to International Diabetes Federation statistics for 2003, there were more than 3.2 million patients with diabetes in the Andean community, nearly 700,000 of which were insulin users.

Oral-lyn, an aerosolized liquid insulin formulation, is rapidly and safely absorbed into the human body through the lining of the inner mouth, called the buccal cavity, when delivered using the company's proprietary RapidMist device, which resembles an asthma inhaler. Unlike certain other alternative insulin-delivery products under development, Oral-lyn does not enter the lungs, officials said.

Toronto, Ont.-based Generex is engaged in the research and development of drug delivery systems and technologies.


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