Generex Biotechnology Demands Retraction of False and Misleading Article

The article states, "Nifty technology, except none of the Oral-Lyn data collected by Generex has not been peer-reviewed in credible medical journals, nor has it been presented at the top-flight diabetes meetings."

• FACT: A number of independent, peer-reviewed studies of Generex Oral-lyn(TM) have been published in journals including Diabetes Care. In addition, Generex Oral-lyn(TM) trial data has been presented in podium posters and abstracts at the annual meetings of the American Diabetes Association (ADA), The Endocrine Society, the European Association for the Study of Diabetes (EASD) and the International Diabetes Federation (IDF) on a regular basis over the past ten years.

The article indirectly attributes to a third-party source that he "is a skeptic because absorption of insulin through the lining of the mouth is too erratic and potentially dangerous."

• FACT: Scientific data contradicts such statements, underscored by the U.S. Food & Drug Administration (FDA) stamp of approval on Generex Oral-lyn(TM) with its inclusion in the Treatment Investigational New Drug (IND) program. The absorption of insulin through the buccal mucosa is much more consistent than through subcutaneous injection, because it is absorbed directly into the blood stream. Absorption through subcutaneous injection is less consistent, as insulin collects at the injection site while it is being absorbed.

The article states, "Oral-Lyn is approved as an alternative to insulin injections in Ecuador, India, Lebanon and Algeria, claims Generex, although the company has not yet recognized revenue from the product."

• FACT: Pursuing regulatory approvals overseas is an ordinary course of action for biotech and pharma companies while the U.S. FDA process in ongoing. The company will continue to pursue regulatory approvals around the globe while the Phase III study continues.

The article quotes a third-party source, "Oral insulin, respiratory insulin, buccally delivered insulin are all marketing driven technologies, they are not driven by the real need of diabetes patients."

• FACT: Multiple independent studies published in Diabetes Research and Clinical Practice, Diabetic Medicine and other journals demonstrate that non-injectable insulin does address a real need of diabetes patients.

Generex Oral-lyn(TM) delivers insulin via the membranes of the oral cavity by a small device that looks like an asthma inhaler. However, unlike inhaled insulin, there is no pulmonary (lung) deposition, nor does the insulin ever enter the GI tract; it is absorbed directly into the bloodstream through the lining of the mouth. Generex Oral-lyn(TM) is in Phase III clinical trials at multiple sites in the U.S. and around the world.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which has been launched in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at