SOURCE: Generex Biotechnology

March 03, 2006 08:45 ET

Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn™

Company Now Has Clear Roadmap to NDS

TORONTO -- (MARKET WIRE) -- March 3, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn™, the Company's proprietary oral insulin spray product for the treatment of diabetes.

The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn™ with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn™ to be marketed and distributed in Canada.

"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn™ and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."

The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn™ by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).

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 (Oral-lyn™), which has been approved for commercial 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

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

    Ed Lewis
    CEOcast, Inc.
    Phone: 1 (212)732-4300