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Generex Biotechnology Announces Successful Equipment & Filling Line Installation for Commencement of Generex Oral-Lyn(TM) Commercial Production


2006-03-27 07:30 ET - News Release

TORONTO -- (MARKET WIRE) -- 03/27/06

http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=114646&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, today announced the successful completion of the delivery and installation of a turnkey Generex Oral-lyn(TM) filling operation at the facilities of PharmaBrand, S.A. (www.pharmabrand.com.ec) in Quito, Ecuador. PharmaBrand is the Company's joint venture partner for the commercialization of Generex Oral-lyn in Latin America. Generex Oral-lyn is the Company's proprietary oral insulin spray product which is designed to replace prandial subcutaneous injections of insulin by delivering insulin into the human body via a spray applied to the buccal mucosa using the Company's proprietary RapidMist(TM) device.

A regulatory compliance and quality control team from Generex will attend at the PharmaBrand facilities early next month to assist in the training of PharmaBrand personnel in respect of the operation of the filling equipment. The Company anticipates that the first commercial production run of 50,000 canisters of Generex Oral-lyn will be completed in April, 2006. Prior to the commencement of that production run, PharmaBrand will have completed the training of its sales force in respect of the new diabetes treatment paradigm offered by Generex Oral-lyn's safe, simple, fast, effective, familiar, and pain-free alternative to prandial insulin injections for patients with either Type-1 or Type-2 diabetes.

The Generex team will also undertake an evaluation of the PharmaBrand manufacturing facilities with a view to assessing the prospect of utilizing those facilities for the production of proteins and peptides to support ongoing research and development in respect of the Antigen Express immunotherapeutic vaccines program.

The Company also responded to a story which appeared on an Internet site Friday afternoon that contained factual inaccuracies. The article referred to the Company's "financial struggles." As indicated in the Company's Form 10-Q Quarterly Report for the fiscal quarter ended January 31, 2006, Generex had cash and short-term investments in excess of $21 million as of January 31, 2006. As at the close of business on March 24, 2006, the Company had cash and short-term investments in excess of $41 million, the strongest financial condition in the Company's history.

The article states that "for the past year, Generex hasn't been able to pay off its debt." That statement is false.

The article states that Generex failed to repay two promissory notes and that "[a]s a result the noteholders (sic) were allowed to convert the debt" into shares of common stock. That statement is false. Had the author reviewed the terms of the debt, he would have seen that the conversion entitlements were included in the promissory notes from the outset. The promissory notes were not repaid in cash on the maturity dates in the context of then on-going negotiations in respect of related transactions. The author states that "Generex also agreed to such terms with other lenders." That is another false statement.

The author makes derisive reference to the Company's losses. Generex is a development stage biotechnology corporation; accordingly, its function has been to spend money on research and development activities which expenditures are recorded as losses. He fails to mention that all of the other small biotechnology companies in the article incurred substantial losses for similar reasons. The author is correct, however, when he makes reference to the Company's expectation of receiving revenue from the sale of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product, by August, 2006.

The author states that Generex is "a stock that faces the threat of delisting." That statement is false. On November 15, 2005, the Company announced that it had received written confirmation from the Nasdaq Stock Market that the Company had achieved compliance with the continued listing requirements in accordance with Nasdaq Marketplace Rule 4310(c)(4). At the present time, Generex very comfortably meets all of the Nasdaq Stock Market quantitative continued listing requirements.

The article is correct when it states that the Antigen Express avian flu vaccine is in pre-clinical development (following a pre-IND meeting with the FDA on February 10, 2006) and that the Antigen Express breast cancer vaccine is in Phase 1 human clinical trials (at Walter Reed Army Medical Center).

"We do not seek to discourage critical review; however, we consider that such review should be based on accurate facts," stated Anna Gluskin, Generex's President & Chief Executive Officer. "The Company made its executives available for the author to speak with. Unfortunately, whatever his underlying motives were, he chose to misstate and distort the facts thereby portraying the Company in an unjustifiably negative manner."

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(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), 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. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.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:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: [phone]
and [phone]

Ed Lewis
CEOcast, Inc.
Phone: [phone]