Needle-Free Generex Oral-lyn(tm) Approved by Lebanese Ministry of
Public Health for Diabetes Management
Benta SAL Will Distribute Product
WORCESTER, Mass., Dec. 23, 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, today announced that Lebanon's Ministry of Public Health has approved Generex Oral-lyn, the Company's proprietary oral insulin spray product, for importation, marketing, distribution, and commercial sale in the Republic of Lebanon for the treatment of adults and children with Type-1 or Type-2 diabetes mellitus.
Benta SAL (www.bpi.com.lb), the Company's licensee in Lebanon and the holder of the largest market share in the supply of pharmaceuticals, medical supplies, and equipment to Lebanese hospitals and public health institutions, is poised to commence the marketing and sale of Generex Oral-lyn in Lebanon early in 2009.
Generex Oral-lyn is designed to offer a simple, convenient, fast, effective, flexible, familiar and pain-free alternative to prandial injections of insulin. Benta's sales force will offer the product throughout Lebanon, covering 1700 pharmacies, 175 hospitals and 23 wholesalers, in addition to public health institutions and dispensaries. Benta also will implement a continuing medical education program to introduce the product to endocrinologists, diabetologists and physicians in Lebanon.
"We are thrilled to make Generex Oral-lyn available to patients with diabeties in Lebanon who are looking for a simpler, pain-free way to effectively manage their disease," said Anna Gluskin, President & Chief Executive Officer of Generex. "Studies have shown that earlier intervention with insulin therapy may delay the onset and progression of diabetes and its numerous complications, and we believe that a convenient alternative to prandial insulin injections could encourage insulin therapy among patients who currently avoid injections."
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 India and Ecuador 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.
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.