SOURCE: Generex Biotechnology

June 22, 2006 09:00 ET

Generex Biotechnology Signs Agreement With Cardinal Health for Generex Oral-lyn™ Manufacturing for Clinical Trials

TORONTO -- (MARKET WIRE) -- June 22, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it has entered into contractual arrangements with Cardinal Health, Inc. (NYSE: CAH), the leading provider of products and services supporting the health-care industry, to manufacture clinical trial batches of Generex Oral-lyn™, a proprietary oral insulin spray product.

Under the terms of the contract, Cardinal Health will formulate and fill clinical trial batches of the canisters at its manufacturing and analytical services facility in Research Triangle Park, NC. Additional terms of the agreement were not disclosed.

Ranked No. 19 on the Fortune 500, Cardinal Health manufactures or packages products for nine out of the top 10 pharmaceutical companies and most leading biotechnology companies. The company manufactures or packages more than half a billion doses of pharmaceuticals every day.

"Cardinal Health's expertise in pharmaceutical manufacturing will be of great value during the remaining trials of our Generex Oral-lyn product," said Anna Gluskin, President and CEO of Generex. "We hope to continue to utilize their proven capabilities as we move forward with the global commercialization of Generex Oral-lyn."

About Generex Oral-lyn™

Generex's flagship product, Generex Oral-lyn™, is an oral insulin spray for the treatment of diabetes. Generex Oral-lyn is a liquid formulation of regular human insulin that is delivered to the buccal mucosa by way of the RapidMist™ device, where absorption is limited to the mouth with no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Generex Oral-lyn an ideal prandial insulin as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia. Generex Oral-lyn can be used as a preventative pharmacologic agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes. The product is already approved for use in Ecuador.

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 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 Web site at 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 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
    (416) 364-2551
    Andrew Hellman
    CEOcast, Inc.
    Phone: (212) 732-4300