Generex Awarded Five New Patents for Its Proprietary Drug Delivery Systems

Company Expands Patent Protection in Canada, Australia, New Zealand, Brazil and Lebanon


WORCESTER, Mass., June 12, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has received five new patents in Canada, Australia, New Zealand, Brazil and Lebanon.

The patents provide additional protection for Generex's proprietary compositions and methodologies for delivering pharmaceuticals in buccal applications. With the addition of these patents, Generex now holds an aggregate of 146 patents worldwide, including 21 in the United States, and has an aggregate of 116 patent applications pending in various jurisdictions throughout the world.

Commenting on the patent awards, Anna Gluskin, the Company's President & Chief Executive Officer, stated, "Generex continues to bolster its intellectual property as we begin to commercialize our revolutionary drug delivery systems throughout the world. We have invested significant resources in developing and protecting our processes and these patents represent another step forward as we continue toward building a solid foundation for the future of our Company."

The Canadian Intellectual Property Office granted the Company its tenth Canadian patent, titled "Micellar Pharmaceutical Compositions for Buccal and Pulmonary Application." The patent contains composition and process claims to pharmaceutical compositions comprising macromolecule pharmaceuticals in micellar form effective in buccal and pulmonary applications.

The Intellectual Property Office of Australia granted the Company a patent titled "Methods of Administering and Enhancing Absorption of Pharmaceutical Agents". This is the fifth Australian patent granted to the Company.

The Intellectual Property Office of New Zealand granted the Company a patent titled "Composition and Method for Raising Blood Glucose Level."

The National Institute of Industrial Property in Brazil granted the Company a patent titled "Mixed Micellar Delivery System and Method of Preparation." The patent contains formulation claims to an improved delivery system for the administration of large molecule pharmaceuticals which may be administered through the oral and nasal membranes. This is the Company's first Brazilian patent.

The patent titled "Pharmaceutical Formulation, Uses of Metered Dose Dispenser Containing Same" was granted to the Company by the Lebanese Intellectual Property Office. The patent contains method, formulation and metered dose dispenser claims for a pharmaceutical formulation for absorption through oral mucosae in mixed micellar form.

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 device. The Company's flagship product, oral insulin (Generex Oral-lyn), which is available for sale in India 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. For more information, visit the Generex website at http://www.generex.com.

The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.



            

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