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Generex Biotechtechnology Files Provisional Application For Oral/Buccal Metformin Patent

Posted on: Thursday, 31 March 2005, 09:00 CST

TORONTO, March 31 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation , a leader in the area of buccal drug delivery, announced today that it has filed a provisional patent application with the United States Patent and Trademark Office for its oral/buccal metformin formulation.

The Company has developed a proprietary platform technology for the delivery of pharmaceuticals into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow pharmaceuticals typically administered by injection or ingestion (i.e. tablets, capsules) to be absorbed into the body by the lining of the inner mouth.

Generex has developed an application of this platform technology to metformin. The Company's liquid metformin formulation, which is the subject matter of the provisional patent application, is designed to facilitate the absorption of the metformin by the oral mucosal membrane in the mouth. The formulation is designed for delivery by way of a lozenge/candy or a chewing gum.

The Company believes that its formulation will offer a much more rapid absorption of metformin than the tablets presently in use and will avoid the adverse gastrointestinal side-effects associated with the tablet form (e.g. nausea, bloating, vomiting, occasional diarrhea) which have a negative impact on patient compliance.

Metformin is indicated for the treatment of diabetes mellitus which cannot be controlled by dietary management, exercise and weight reduction, or when insulin therapy is not appropriate. Metformin is prescribed for the treatment of patients with Type II diabetes, including children. It assists patients in achieving control of elevated blood sugar levels without stimulating insulin production (i.e. no hypoglycemia). Metformin can also be of value in the treatment of obese patients with diabetes due to its appetite suppression effects and it may ameliorate polycystic ovary disease. The total US market sales of all forms of metformin are approximately $1.8 billion (IMS-MAT: December 2003).

"We are very excited about the prospects for this latest application of our drug delivery platform developed by our in-house research team," said Anna Gluskin, Generex's President & Chief Executive Officer. "This new application should improve patient compliance, thereby enhancing the efficacy of this important diabetes therapy."

In connection with the clinical and regulatory development program for Oral-lyn(TM), the Company's proprietary oral insulin formulation, the Company sponsored several clinical studies involving Oral-lyn(TM) - metformin combination therapies. The Company believes that a combination therapy of oral insulin and oral metformin will present an opportunity for a significant new therapeutic paradigm for the treatment of II diabetes mellitus which will improve patient compliance and quality of life and postpone the complications associated with diabetes.

About Generex

Generex is engaged in the research and development 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 (Oral- lyn(TM)), is in various stages of clinical trials around the world.

For more information, visit the Generex Web site at http://www.generex.com/ .

Safe Harbor Statement: 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.

Generex Biotechnology Corporation

CONTACT: Shayne Gilliatt of Generex Biotechnology Corporation,1-800-391-6755, or +1-416-364-2551; Ed Lewis of CEOcast, Inc., +1-212-732-4300, elewis@ceocast.com, for Generex Biotechnology Corporation

Web site: http://www.generex.com/

Source: PRNewswire-FirstCall

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