WORCESTER, Mass., Oct. 15, 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 an update from its Middle Eastern master licensee, Leosons General Trading Company, a leading distributor of North American healthcare products in the region, on the status of regulatory filings for Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product.
Leosons has filed submissions of the Generex Oral-lyn dossier with regulatory agencies in Kuwait, Qatar, Jordan, Yemen, and the United Arab Emirates. The objective of these submissions is to procure requisite governmental approvals for the importation, marketing, distribution, and sale of Generex Oral-lyn in those jurisdictions.
According to the International Diabetes Federation, the UAE has the second highest incidence of diabetes in the world, affecting 70% of the population. Other countries in the region also have significant incidences of diabetes, with Saudi Arabia ranked third, Bahrain fourth, Kuwait fifth, and Oman sixth. Leosons, based in the UAE, has responsibility for the procurement of all Middle Eastern governmental approvals for the importation, marketing, distribution, and sale of Generex Oral-lyn. Following receipt of approvals, Leosons will market, distribute, and sell the product through its extensive distribution networks in the region. Leosons will, at its sole expense, design and implement plans for the education and training of patients and physicians in the region in respect of the Company's RapidMist(tm) Diabetes Management System and the use of Generex Oral-lyn. Leosons will also be obligated to achieve minimum quarterly sales of the product.
"We are pleased about the progress being made by our master licensee in the Middle East," says Anna Gluskin, Generex's President and Chief Executive Officer. "It reflects the quality of the Company's Generex Oral-lyn dossier that Leosons' review determined that the dossier meets all the necessary requirements for the Middle Eastern regulatory agencies. We believe Generex Oral-lyn will address a major unmet medical need in the region for its large population living with diabetes."
About Leosons
Leosons is a 25-year-old private multinational operating company in the Middle East focusing on the pharmaceutical and healthcare industry. Leosons distributes 15 healthcare-related products which are considered category leaders.
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)), 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. In June, 2007 the Company announced the commencement of a global Phase III clinical trial of Generex Oral-lyn(tm) in the third quarter of 2007 with patient dosing to commence before yearend. 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.