Generex Biotechnology Corporation Oral-lyn™, the Company’s proprietary oral insulin spray formulation, and its RapidMist™ Diabetes

TORONTO, October 5, 2004 – Generex Biotechnology Corporation (NasdaqSC:
GNBT) announced today that Oral-lyn™, the Company’s proprietary oral insulin spray formulation, and its RapidMist™ Diabetes Management System were featured by PharmaBrand S.A. at its exhibit at the Latin American Diabetes Association 12th Latin American Diabetes Congress held in São Paolo, Brazil, September 26 – 29, 2004. PharmaBrand, a pharmaceuticals company based in Quito, Ecuador, is the Company’s joint venture partner for the commercialization of Oral-lyn™ in Central and South America. Attendee interest in Oral-lyn™ was high, with more than 2,500 pieces of information on Oral-lyn™ being distributed from the exhibit.

“This congress represents a successful introduction of the concept of Oral-lyn™ as a diabetes treatment in Central and Latin America and we are pleased by the enthusiastic reception of the healthcare professionals attending the congress,” said Dr. Roberto Cid, President of PharmaBrand. 
“We look forward to the prosecution of the Oralin™ dossier for marketing and distribution submitted to the Ecuadorian Ministry of Public Health in August.”

The International Diabetes Federal (IDF) estimates that there are approximately 11 million adults with diabetes in Central and South America, representing a prevalence of 4.8%.

Diabetes Action Now is a joint program of the World Health Organization and the IDF. In a Diabetes Action Now podium presentation at the congress, diabetes was described as an “international epidemic” requiring long-term management of risks and co-morbidities across the boundaries of many specialties such as nephrology, neurology, cardiology, perinatology, and surgery. A partnership has been proposed between Diabetes Action Now and the International Diabetes Center (IDC) which will focus on prevention, early detection and intensive treatment to prevent complications associated with diabetes.

Oral-lyn™ is a liquid formulation of regular human insulin that is delivered to the buccal mucosa by way of the RapidMist™ device, a device similar to an asthma device, however, absorption is limited to the buccal mucosa with no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Oral-lyn™ an ideal prandial insulin as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia.

In an IDC podium presentation at the congress entitled “Diabetes and Obesity in America”, it was noted that approximately 20 million Americans suffer from pre-diabetes. People who have blood glucose levels that are higher than normal but not high enough to be type 2 diabetes have pre-diabetes, also know as “impaired glucose tolerance” (IGT). In individuals with IGT, the body does not use insulin efficiently, forcing the pancreas to work harder to reduce blood glucose levels. Eventually, the pancreas tires and type 2 diabetes begins. In addition, conventional oral medications currently used to treat patients with type 2 diabetes accelerate the degradation of pancreatic function and the consequent insulin dependence, resulting in insulin requiring type 2 diabetes.

Generex believes that Oral-lyn™ can be used as a preventative pharmacologic agent by people with pre-diabetes to delay the onset of diabetes and by patients with type 2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes that can affect the eyes, heart, kidneys, feet and sexual function, primarily due to blood vessel damage. Data from the 10-year Diabetes Control and Complications Trial concluded in 1993 and the United Kingdom Prospective Diabetes Study that ended in 1999 showed that keeping A1C in target helps to prevent or slow the progress of diabetes complications. Just a 1% drop in A1C can decrease the risk of eye, kidney and nerve damage by 25 – 30%.

About Generex
Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs. This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward- looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.