SOURCE: Generex Biotechnology

November 14, 2006 09:45 ET

First Metformin Gum Patent Granted to Generex Biotechnology

TORONTO -- (MARKET WIRE) -- November 14, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has been granted the first patent for its medicinal gum platform titled "Compositions for Oral Transmucosal Delivery of Metformin." The patent covers claims to the composition, processes, and methodologies for the delivery of an oral transmucosal metformin composition via the oral mucosal membrane for absorption.

This patent was issued by the Lebanese Ministry of National Economy Intellectual Property Protection Office. As a consequence of Lebanon's accession to the international Patent Co-operation Treaty, this patent will open the door to further filings in the other PCT signatory countries.

Metformin is a generic drug used to regulate blood glucose (sugar) levels by reducing the amount of glucose produced by the liver, and by making the insulin produced by the body work more effectively to reduce the amount of glucose already in the blood. Metformin has been in use around the world for more than 30 years. It remains the most prescribed drug for Type-2 diabetes, a testimony to its efficacy and its prominent place in diabetes therapy. The total US market sales of all forms of metformin are approximately $1.8 Billion (IMS-MAT: December 2003).

The patent relates to an oral transmucosal metformin composition comprising a pharmaceutically acceptable carrier being capable of delivering a pharmaceutically effective amount of metformin to the oral mucosal membrane for absorption.

"We are very pleased to receive the first patent for our metformin gum product, a product that complements our flagship product, Generex Oral-lyn™, and related diabetes pipeline," said Rose C. Perri, the Generex Chief Operating Officer.

The Company currently holds an aggregate of 80 patents worldwide (20 of which are United States Patents) and has an aggregate of 60 patent applications pending in various jurisdictions.

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™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. For more information, visit the Generex website at

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 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 Information

  • Contacts:

    Shayne Gilliatt
    Generex Biotechnology Corporation
    Phone: (800) 391-6755
    or (416) 364-2551

    Andrew Hellman
    CEOcast, Inc.
    Phone: (212) 732-4300

    Dolores Naney
    Rubenstein Public Relations
    Phone: (212) 843-8018
    Email Contact