WORCESTER, Mass., Nov. 5, 2008 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, submitted its product dossier to the Ministry of Health in Damascus, Syria on Sunday.
The dossier was submitted by Leo Ohanian, managing director of Generex MENA, and Dr. Mustafa Aljabi of Aljabi Drug Store, Damascus. The dossier includes Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product that provides a safe, effective and pain-free alternative to subcutaneous injections of prandial insulin for the treatment of Type I and Type II diabetes. It is estimated that among Syria's population of 20 million, between 3 million and 3.5 million people have diabetes.
Generex also submitted a file to register its proprietary over-the-counter products, including Glucose RapidSpray(tm), 7-Day Diet Aid Spray(tm) and BaBOOM!(tm) Energy Spray. Glucose RapidSpray(tm) is conveniently packaged to be carried in a purse, pocket, car or other convenient place and is designed for use at the first sign of needing additional glucose. 7-Day Diet Aid Spray(tm) can help dieters satisfy cravings between meals, and BaBOOM!(tm) Energy Spray is an instant and sustaining energy alternative to beverages or shots. All three products are sprayed into the mouth and absorbed into the bloodstream for rapid action.
The Syrian Ministry of Health will review the dossier and inform Generex of any additional requests for information that they may have. There have been no immediate queries, and Generex anticipates registration before the end of 2009.
Generex Oral-lyn(tm) was featured last week at the 2nd International Diabetes Federation Regional MENA Diabetes Conference and 17th Annual Meeting of the Syrian Diabetes Association in Lattakia, Syria. The international conference brings together four hundred doctors and endocrinologists from throughout the Middle East and North Africa, whose population suffers from an average diabetes rate of over 20 percent.
About Generex Biotechnology Corporation
Generex is engaged in the research, development and commercialization 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 and approved for sale in India for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
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Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 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.