Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has reviewed the positive data from its bioequivalent study with MetControl, its proprietary metformin chewing gum product study conducted in November 2008. Results of the fully compliant ICH-GCP conducted study indicate that MetControl chewing gum and traditional Metformin tablets are bioequivalent in respect of both the rate and the extent of systemic absorption. Management believes the results provide convincing evidence that MetControl and Metformin tablets are therapeutically equivalent and therefore interchangeable.

The company is currently preparing the data in a form for submission to various regulatory authorities throughout the world. Management intends to complete a marketing assessment in the coming months in order to determine the number and order of regulatory submissions it will undertake and anticipates making submissions beginning in the first quarter of 2010.

Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving the insulin sensitivity of cells. Through this action, Metformin allows the insulin produced by the body to be used more effectively and ultimately reduces the amount of glucose in the blood. Metformin is the backbone of almost all treatments for type-2 diabetes mellitus. It has a broad range of beneficial qualities for this extremely complex disease.

While Metformin is currently the most prescribed drug for type-2 diabetes, there is a significantly large population of diabetics who do not use it for a variety of reasons, including gastrointestinal side effects, large pill size and bitter taste. These are particularly important factors when considering the expanding population of children with type-2 diabetes. Management believes MetControl overcomes these obstacles making the drug more acceptable to patients which will not only lead to more compliance with the therapy but also increase its usage substantially among the diabetic population.

Commenting on the review of results, Anna Gluskin, the company's president & chief executive officer, stated, "This study and our review of results have strengthened our belief that MetControl will have a huge positive impact in the company's near term future. We intend to use all the resources available to us to expedite our process to determine those regulatory authorities we wish to target and prepare submissions to achieve necessary approvals. This product represents an opportunity to enter a multi-billion dollar market with a product we believe possesses substantial advantages over what is on the market today."

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies.