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Generex Sees Favorable Results From MetControl(tm) Chewing Gum Bio-equivalency Study Leading to Global Product Submissions
Company Plans to Begin Global Product Submissions Into the Multi-billion Dollar Metformin Market in the First Quarter of 2010
Press Release
Source: Generex Biotechnology Corp.
On Monday June 29, 2009, 9:30 am EDT
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Companies:Generex biotechnology corp.
WORCESTER, Mass., June 29, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News; www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that the company has reviewed the positive data from its bioequivalent study with MetControl(tm), its proprietary metformin chewing gum product study conducted in November 2008. Results of the fully compliant ICH-GCP conducted study indicate that MetControl(tm) 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(tm) and Metformin tablets are therapeutically equivalent and therefore interchangeable.

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{"s" : "gnbt","k" : "c10,l10,p20,t10","o" : "","j" : ""} 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(tm) 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(tm) 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."

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 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.

Contact:
American Capital Ventures, Inc.Investor Relations Contact:Howard Gostfrand1-877-918-0774Avalanche Strategic CommunicationsMedia Contact:Angelene Taccini201-488-0049​