WORCESTER, Mass., July 10, 2007 (PRIME NEWSWIRE) -- 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 entered into an exclusive Product Licensing & Distribution Agreement with the Armenian Development Agency (ADA) (www.ada.am) and Canada Armenia Trading House Ltd. (CATH) for the commercialization of Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product, in the Republic of Armenia, Georgia, and the Republic of Kazakhstan. ADA and CATH will bear any and all costs associated with the procurement of governmental approvals for the sale of the product, including any clinical and regulatory costs.
The ADA was established in 1998 by the Government of the Republic of Armenia. The Armenian Government considers the ADA to be the main national intermediary for bridging gaps between policy development and implementation and the public and private sectors. The Chairman of the Board of the ADA is the Prime Minister of the Republic of Armenia. It is estimated that more than 8.1% of the people in Armenia, 9% of the people in Georgia, and 5.5% of the people in Kazakhstan suffer from diabetes and its complications.
"We are pleased to have established this relationship with the Armenian Development Agency and Canada Armenia Trading House," said Anna Gluskin, the Company's President & Chief Executive Officer. "We hope that with the growing prevalence of diabetes that more than one million people in Armenia, Georgia and Kazakhstan will eventually treat their diabetes with Generex Oral-lyn(tm). We will continue to pursue international governmental approvals of Generex Oral-lyn around the world as we proceed with the Phase 3 trials in the United States, Canada, and Europe."
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 (Generex Oral-lyn(tm)), is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, and before the end of 2007 the Company expects to begin Phase 3 trials of the product in the United States, Canada, and Europe. For more information, visit the Generex website 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.